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The digital placebo effect: Mobile mental health meets clinical psychiatry

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... Here, we report the findings of effectiveness pilot intervention studies that tested the capacity of Sun Safe to affect sun health knowledge and behaviors of young adolescents under real-world conditions. This research was conducted in 2020, with data collected across 3 pilot trials because of the impact of the COVID-19 pandemic (Multimedia Appendix 1) [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32]. Our objectives are to obtain end user responses to Sun Safe, pilot-test its capacity to improve the sun health knowledge and behaviors of young adolescents (aged 12-13 years), estimate its likely acceptance and effectiveness, provide data to estimate sample sizes, and test recruitment strategies and methods for future definitive trials. ...
... The placebo app selected was the SunDial iOS app (version 6.2, 2020), which notifies the user when sunrise and sunset events occur [15]. A placebo app was required to control for the digital placebo effect, which may occur when being involved in a digital intervention study [16]. Participants were blinded to which were the test (Sun Safe) and placebo (SunDial) apps and were initially encouraged to download and use either app (for free) through email or information provided during an in-class session. ...
... Results were analyzed using Microsoft Excel (version 16 ...
Article
Background A balanced approach toward sun exposure and protection is needed by young people. Excessive sun exposure increases their risk for skin cancers such as melanoma, whereas some exposure is necessary for vitamin D and healthy bones. We have developed a new iOS smartphone app—Sun Safe—through a co-design process, which aims to support healthy and balanced decision-making by young teenagers (aged 12-13 years). Objective The aim of this study was to test the capacity of Sun Safe to improve sun health knowledge and behaviors of young teenagers in 3 pilot intervention studies completed in 2020. Methods Young teenagers (aged 12-13 years; N=57) were recruited through the web or through a local school via an open-access website and given access to Sun Safe (29/57, 51%) or a placebo (SunDial) app (28/57, 49%). Participants completed sun health questionnaires and knowledge quizzes before and after the 6-week intervention (either on the web or in class) and rated the quality of the app they used via a survey. Results Of the 57 participants, 51 (89%) participants (26, 51% for placebo arm and 25, 49% for the Sun Safe arm) completed these studies, with most (>50%) reporting that they used a smartphone to access their designated app either “once a fortnight” or “once/twice in total.” Improved sun health knowledge—particularly about the UV Index—was observed in participants who were given access to Sun Safe compared with those who used the placebo (−6.2 [percentage correct] difference in predicted means, 95% CI –12.4 to –0.03; P=.049; 2-way ANOVA). Unexpectedly, there were significantly more sunburn events in the Sun Safe group (relative risk 1.7, 95% CI 1.1-1.8; P=.02; Fisher exact test), although no differences in time spent outdoors or sun-protective behaviors were reported. COVID-19 pandemic–related community-wide shutdowns during April 2020 (when schools were closed) reduced the time spent outdoors by >100 minutes per day (–105 minutes per day difference in predicted means, 95% CI –150 to –59 minutes per day; P=.002; paired 2-tailed Student t test). Sun Safe was well-rated by participants, particularly for information (mean 4.2, SD 0.6 out of 5). Conclusions Access to the Sun Safe app increased sun health knowledge among young teenagers in these pilot intervention studies. Further investigations with larger sample sizes are required to confirm these observations and further test the effects of Sun Safe on sun-protective behaviors.
... Further considerations that we have not elaborated on relate to mobile Health (or "mHealth") including apps aimed at helping patients to manage their illnesses or symptoms. Artifactual features of mobile devices, for example, might augment the size of placebo effects (Torous and Firth, 2016;Pontén et al., 2019). Similarly, incidental features in the design of mHealth apps, for example, how sophisticated the imagery or graphic design aremight also be conceived of as non-medical physical artifacts -that might augment (or diminish) placebo effects. ...
... This is especially important as there are measurable effects of smartphone-based interventions for several health conditions, such as depression (Firth et al., 2017), and owing to their potential, the U.S. Food and Drug Administration (FDA) has already approved some health applications as digital-based drugs (Waltz, 2018). Hence, we suggest that design features of eHeath innovations may influence artifactual placebo effects (Torous and Firth, 2016), a consideration that warrants further exploration. ...
Article
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Research in social psychology demonstrates that physical environmental factors – or “artifacts” such as provider clothing and office décor – can influence health outcomes. However, the role of artifacts in augmenting or diminishing health outcomes is under-explored in the burgeoning discipline of placebo studies. In this paper, we argue that a careful consideration of artifacts may carry significant potential in informing how placebo effects can be maximized, and nocebo effects minimized in clinical settings. We discuss the potential mechanisms, including classical conditioning, response expectancy, and mindsets, by which artifacts might enhance or diminish these effects. Next, we propose testable hypotheses to investigate how placebo and nocebo effects might be elicited by artifacts in care settings, and conclude by providing innovative research designs to advance this novel research agendum.
... Despite these advancements, there is still a lack of consensus on how to determine the efficacy and safety of these apps. 55 ...
... It is widely recognized that there is a high risk of bias in clinical trials in this area because of the inability to blind the intervention, thus triggering the phenomenon that some authors call the digital placebo effect. 55 The rapid pace of innovation of digital technology might hinder the use of this methodology to assess the impact. 60 The extended period from recruitment to publication, the high costs, and a rigid protocol make randomized controlled clinical trials an impractical evaluation methodology for most mHealth apps. ...
Article
Background: The recent mobile technology advancements, such as the development of applications (apps) for mobile phones and tablets, can assist in the development of low-cost platforms to monitor therapeutic adherence or complications, providing easily accessible information or guidelines in self-care focused on the care recipient. Objective: The aim of this study was to gather scientific evidence about the efficacy of the use of mobile apps during chemotherapy treatments. Methods: A systematic review of quantitative studies was performed. All articles published until May 31, 2019 were identified in databases MEDLINE, CINAHL Psychology and Behavioral Sciences Collection, and Cochrane Library. Results: A total of 10 quantitative studies were included. A set of metrics was identified that essentially analyze issues related to the devices' functionalities. The metrics associated with engagement and related to behavioral dimensions, associated with the use of/adherence to the mobile app, are predominant. The clinical metrics represent 25 of a total of 53 identified metrics. Beneficial and statistically significant results were identified related to fatigue, self-efficacy, and improvements in reports of complications. Conclusion: Based on the available research, mobile apps are likely to be a useful and acceptable tool to monitor interventions and complications. In addition, mobile apps can help in the self-management of treatment-related complications. Importantly, these apps need to bridge the academic context and clinical practice, by evaluating the impact of the use of mobile apps in patients. Implications for practice: The concept of prescribing apps is being addressed to ensure that apps work and have fair privacy and data security policies that address safety requirements.
... Within two meta-analyses, effect sizes were smaller when comparing interventions with active, rather than wait-list control conditions, suggesting change may not be underpinned by psychotherapeutic elements of interventions. However, it is difficult to estimate the size and efficacy of potential expectancy effects due to the lack of methodologically robust research (Torous and Firth, 2016); thus, such effects are yet to be understood. Given the risk of bias associated with poor allocation concealment within RCTs (Gellatly et al., 2007;Schulz, 1995), more attention should be paid to ensure the quality of studies. ...
... Additionally, research investigating the longevity of effects was recommended, as effects have yet to demonstrate long-term efficacy (Batra et al., 2017;Menon et al., 2017;Rathbone et al., 2017;Wickersham et al., 2019). Whilst these investigations would enable validation of apps, and potentially highlight iatrogenic effects, they would not demonstrate the processes fundamental to change (Torous and Firth, 2016). Whilst mechanisms may be investigated within RCTs via mediational analyses (Kraemer et al., 2002), it should be noted that mediation does not equate to mechanism (Nock, 2007). ...
Article
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Purpose: A rapid increase in global smartphone ownership and digital health technologies offers the potential for mobile phone applications to deliver mental health interventions. The purpose of this umbrella review was to bring together evidence reporting on mental health mobile applications to gain an understanding of the quality of current evidence, the positive and adverse effects of applications, and the mechanisms underlying such effects. Design/methodology/approach: A systematic search was carried out across six databases, for any systematic reviews or meta-analyses conducted up to 2020. Review quality was assessed using the Assessment of Multiple Systematic Reviews (AMSTAR 2). Findings: Across a total of 24 articles, a variety of clinical outcomes were assessed. Most compelling support was shown for applications targeting anxiety symptoms; some evidence favoured the use of applications for depression symptoms. Less evidence was available for the remaining clinical symptoms such as bipolar disorder, schizophrenia, post-traumatic stress disorder, sleep disorders, and substance use. Overall, there was limited evidence pertaining to adverse effects and change mechanisms, and a lack of quality reporting across a large proportion of included reviews. The included reviews demonstrate the need for further robust research before applications are recommended clinically. Originality: This umbrella review makes a valuable contribution to the current status of research and reviews investigating mental health mobile apps. Recommendations are made for improved adherence to review guidelines, to ensure risk of bias is minimised.
... As it was not possible to blind participants, the groups differed in their expectation of improvement, and a placebo effect in the intervention group could have inflated ESs or made a type I error more likely. In particular, a so-called digital placebo has been suggested by some researchers, in that the observed benefits could arise from the increased use of the electronic device itself [44]. Nevertheless, this intervention requires such little investment on the part of distributors and patients alike that this would not discredit its use entirely, particularly for those who are waiting for another treatment. ...
Article
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Background Depression and anxiety symptoms are common among university students, but many do not receive treatment. This is often because of lack of availability, reluctance to seek help, and not meeting the diagnostic criteria required to access services. Internet-based interventions, including smartphone apps, can overcome these issues. However, a large number of apps are available, each with little evidence of their effectiveness. Objective This study aims to evaluate for the first time the effectiveness of a self-guided mobile app, Feel Stress Free, for the treatment of depression and anxiety symptoms in students. Methods A web-based randomized controlled trial compared a cognitive behavioral therapy (CBT)–based mobile app Feel Stress Free with a wait-list control. University students self-identified as experiencing symptoms of anxiety or depression and were randomized to 6 weeks of intervention (n=84) or control (n=84), unblinded. The app is self-guided and incorporates behavioral relaxation activities, mood tracking and thought challenging, and minigames. Participants completed the Hospital Anxiety and Depression Scale online at baseline and every fortnight. Results At week 6, the primary end point, there was evidence that the Feel Stress Free app reduced depression symptoms (mean difference −1.56; 95% CI −2.67 to −0.44; P=.006) but only very weak evidence that it reduced anxiety symptoms (mean difference −1.36; 95% CI −2.93 to 0.21; P=.09). At week 4, there was evidence to support the effectiveness of the intervention for anxiety symptoms (mean difference −1.94; 95% CI −3.11 to −0.77; P=.001) and, though weaker, depression symptoms (mean difference −1.08; 95% CI −2.12 to −0.04; P=.04). At week 6, 83% (34/41) of participants indicated that they were using the app weekly or more frequently. Conclusions The Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT. Further research is needed to establish its effectiveness at and beyond 6 weeks. Trial Registration ClinicalTrials.gov NCT03032952; https://clinicaltrials.gov/ct2/show/NCT03032952
... It should, therefore, be easier for investigators to conceal group assignments from participants and investigators alike. It has previously been speculated that a "digital placebo effect" exists [79]. Designs including a digital control arm should have the additional benefit of controlling more effectively for such an effect than studies that do not include a digital control arm. ...
Article
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There is increasing interest in the use of technology to support social health in dementia. The primary objective of this systematic review was to synthesize evidence of effectiveness of digital technologies used by people with dementia to improve self-management and social participation. Records published from 1 January 2007 to 9 April 2020 were identified from Pubmed, PsycInfo, Web of Science, CINAHL, and the Cochrane Central Register of Controlled Trials. Controlled interventional studies evaluating interventions based on any digital technology were included if: primary users of the technology had dementia or mild cognitive impairment (MCI); and the study reported outcomes relevant to self-management or social participation. Studies were clustered by population, intervention, and outcomes, and narrative synthesis was undertaken. Of 1394 records identified, nine met the inclusion criteria: two were deemed to be of poor methodological quality, six of fair quality, and one of good quality. Three clusters of technologies were identified: virtual reality, wearables, and software applications. We identified weak evidence that digital technologies may provide less benefit to people with dementia than people with MCI. Future research should address the methodological limitations and narrow scope of existing work. In the absence of strong evidence, clinicians and caregivers must use their judgement to appraise available technologies on a case-by-case basis.
... Evidence from meta-analyses has already demonstrated some efficacy of smartphone-delivered therapies for reducing both depression and anxiety [60]. However, the extent to which benefits observed in these trials are due to active components of the therapies themselves, as opposed to individuals connection with their smart devices and expectations for benefit, has yet to be fully determined [61]. ...
Article
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The rapid uptake of the internet has provided a new platform for people to engage with almost all aspects of life. As such, it is currently crucial to investigate the relationship between the internet and cognition across contexts and the underlying neurobiological mechanisms driving this. We describe the current understanding of this relationship across the literature and outline the state of knowledge surrounding the potential neurobiological drivers. Through focusing on two key areas of the nascent but growing literature, first the individual- and population-level implications for attention processes and second the neurobiological drivers underpinning internet usage and memory, we describe the implications of the internet for cognition, assess the potential mechanisms linking brain structure to cognition, and elucidate how these influence behaviour. Finally, we identify areas that now require investigation, including (i) the importance of the variation in individual levels of internet usage, (ii) potential individual behavioural implications and emerging population-level effects, and the (iii) interplay between age and the internet–brain relationships across the stages of development.
... The lack of a follow-up assessment is another limitation, making it unclear whether any benefits were sustained. Furthermore, the lack of active control conditions makes it impossible to rule out effects due to a digital placebo [123]. Similarly, the included self-report measures are vulnerable to social desirability bias, although this may be less of an issue within a fully remote RCT [124]. ...
Article
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Background A growing number of randomized controlled trials (RCTs) suggest psychological benefits associated with meditation training delivered via mobile health. However, research in this area has primarily focused on mindfulness, only one of many meditative techniques. Objective This study aims to evaluate the efficacy of 2 versions of a self-guided, smartphone-based meditation app—the Healthy Minds Program (HMP)—which includes training in mindfulness (Awareness), along with practices designed to cultivate positive relationships (Connection) or insight into the nature of the self (Insight). Methods A three-arm, fully remote RCT compared 8 weeks of one of 2 HMP conditions (Awareness+Connection and Awareness+Insight) with a waitlist control. Adults (≥18 years) without extensive previous meditation experience were eligible. The primary outcome was psychological distress (depression, anxiety, and stress). Secondary outcomes were social connection, empathy, compassion, self-reflection, insight, rumination, defusion, and mindfulness. Measures were completed at pretest, midtreatment, and posttest between October 2019 and April 2020. Longitudinal data were analyzed using intention-to-treat principles with maximum likelihood. Results A total of 343 participants were randomized and 186 (54.2%) completed at least one posttest assessment. The majority (166/228, 72.8%) of those assigned to HMP conditions downloaded the app. The 2 HMP conditions did not differ from one another in terms of changes in any outcome. Relative to the waitlist control, the HMP conditions showed larger improvements in distress, social connectedness, mindfulness, and measures theoretically linked to insight training (d=–0.28 to 0.41; Ps≤.02), despite modest exposure to connection- and insight-related practice. The results were robust to some assumptions about nonrandom patterns of missing data. Improvements in distress were associated with days of use. Candidate mediators (social connection, insight, rumination, defusion, and mindfulness) and moderators (baseline rumination, defusion, and empathy) of changes in distress were identified. Conclusions This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social connectedness. Future studies should attempt to increase study retention and user engagement. Trial Registration ClinicalTrials.gov NCT04139005; https://clinicaltrials.gov/ct2/show/NCT04139005
... The potential mechanism by which smartphone interventions reduce symptoms of BD might be explained by using these devices to support and enhance the delivery of existing face-to-face therapy [25] . The use of smartphone-based interventions may provide creative and innovative interventions, filling the gap between feasibility and the demand for treatment [39] . Additionally, interventions via smartphone devices may remedy some limitations of existing traditional therapy in the future, with the advantages of convenience and lower treatment cost. ...
Article
Background: Recently, there has been a range of studies about smartphone-based interventions and monitoring for reducing symptoms of bipolar disorder (BD). However, their efficacy for BD remains unclear. Aim: To compare the effect of smartphone-based interventions and monitoring with control methods in treating patients with BD. Methods: A systematic literature search was performed on PubMed, Embase, Clinical trials, psycINFO, Web of Science, and Cochrane Library. Randomized clinical trials (RCTs) or single-group trials in which smartphone-based interventions and monitoring were compared with control methods or baseline in patients with symptoms of BD were included. Data were synthesized using a random-effects or a fixed-effects model to analyze the effects of psychological interventions and monitoring delivered via smartphone on psychiatric symptoms in patients with BD. The primary outcome measures were set for mania and depression symptoms. Subgroups were created to explore which aspects of smartphone interventions are relevant to the greater or lesser efficacy of treating symptoms. Results: We identified ten articles, including seven RCTs (985 participants) and three single-group trials (169 participants). Analysis of the between-group study showed that smartphone-based interventions were effective in reducing manic [g = -0.19, 95% confidence interval (CI): -0.33 to -0.04, P = 0.01] and depressive (g = -0.28, 95%CI: -0.55 to -0.01, P < 0.05) symptoms. In within-group analysis, smartphone-based interventions significantly reduced manic (g = 0.17, 95%CI: 0.04 to 0.30, P < 0.01) and depressive (g = 0.48, 95%CI: 0.18 to 0.78) symptoms compared to the baseline. Nevertheless, smartphone-based monitoring systems significantly reduced manic (g = 0.27, 95%CI: 0.02 to 0.51, P < 0.05) but not depressive symptoms. Subgroup analysis indicated that the interventions with psychoeducation had positive effects on depressive (g = -0.62, 95%CI: -0.81 to -0.43, P < 0.01) and manic (g = -0.24, 95%CI: -0.43 to -0.06, P = 0.01) symptoms compared to the controlled conditions, while the interventions without psychoeducation did not (P > 0.05). The contacts between therapists and patients that contributed to the implementation of psychological therapy reduced depression symptoms (g = -0.47, 95%CI: -0.75 to -0.18, P = 0.01). Conclusion: Smartphone-based interventions and monitoring have a significant positive impact on depressive and manic symptoms of BD patients in between-group and within-group analysis.
... Such "observational studies" are experiencing rediscovery and support not only by patients and patient organizations but also by approval authorities. However, eliminating placebos in drug testing does not eliminate the placebo response that is inherent to all medical (and psychological) interventions, even when provided by computerized algorithms-the digital placebo response (11). It has recently been proposed that even with open-label observational studies, proper control of some of the mediators of the placebo response is feasible (12) and thereby insists on a scientific rather than a pragmatic approach. ...
Article
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Much has been written about the placebo effects in functional gastrointestinal disorders (FGD), especially in irritable bowel syndrome (IBS), driven by the early hypothesis that in randomized controlled trials (RCTs) of IBS, the placebo effect might be specifically high and thus, corrupts the efficacy of novel drugs developed for this condition. This narrative review is based on a specific search method, a database (www.jips.online) developed since 2004 containing more than 4,500 papers (data papers, meta-analyses, systematic reviews, reviews) pertinent to the topic placebo effects/placebo response. Three central questions—deducted from the body of current literature—are addressed to explore the evidence behind this hypothesis: What is the size placebo effect in FGD, especially in IBS, and is it different from the placebo effect seen in other gastrointestinal disorders? Is the placebo effect in FGD different from other functional, non-intestinal disorders, e.g. in other pain syndromes? Is the placebo effect in FGD related to placebo effects seen in psychiatry, e.g. in depression, anxiety disorders, and alike? Following this discussion, a fourth question is raised as the result of the three: What are the consequences of this for future drug trials in FGD? In summary it is concluded that, contrary to common belief and discussion, the placebo effect seen in RCT in FGD is not specifically high and extraordinary as compared to other comparable (i.e. functional) disorders. It shares less than expected commonalities with the placebo effect in psychiatry, and very few predictors have yet been identified that determine its effect size, especially some that are driven by design features of the studies. Current practice of RCT in IBS seems to limit and control the placebo effect quite well, and future trial practice, e.g. head-to-head trial, still offers options to maintain this control, even in the absence of placebos used.
... As it was not possible to blind participants, the groups differed in their expectation of improvement, and a placebo effect in the intervention group could have inflated ESs or made a type I error more likely. In particular, a so-called digital placebo has been suggested by some researchers, in that the observed benefits could arise from the increased use of the electronic device itself [44]. Nevertheless, this intervention requires such little investment on the part of distributors and patients alike that this would not discredit its use entirely, particularly for those who are waiting for another treatment. ...
Preprint
BACKGROUND Depression and anxiety symptoms are common among university students, but many do not receive treatment. This is often because of lack of availability, reluctance to seek help, and not meeting the diagnostic criteria required to access services. Internet-based interventions, including smartphone apps, can overcome these issues. However, a large number of apps are available, each with little evidence of their effectiveness. OBJECTIVE This study aims to evaluate for the first time the effectiveness of a self-guided mobile app, Feel Stress Free, for the treatment of depression and anxiety symptoms in students. METHODS A web-based randomized controlled trial compared a cognitive behavioral therapy (CBT)–based mobile app Feel Stress Free with a wait-list control. University students self-identified as experiencing symptoms of anxiety or depression and were randomized to 6 weeks of intervention (n=84) or control (n=84), unblinded. The app is self-guided and incorporates behavioral relaxation activities, mood tracking and thought challenging, and minigames. Participants completed the Hospital Anxiety and Depression Scale online at baseline and every fortnight. RESULTS At week 6, the primary end point, there was evidence that the Feel Stress Free app reduced depression symptoms (mean difference −1.56; 95% CI −2.67 to −0.44; P =.006) but only very weak evidence that it reduced anxiety symptoms (mean difference −1.36; 95% CI −2.93 to 0.21; P =.09). At week 4, there was evidence to support the effectiveness of the intervention for anxiety symptoms (mean difference −1.94; 95% CI −3.11 to −0.77; P =.001) and, though weaker, depression symptoms (mean difference −1.08; 95% CI −2.12 to −0.04; P =.04). At week 6, 83% (34/41) of participants indicated that they were using the app weekly or more frequently. CONCLUSIONS The Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT. Further research is needed to establish its effectiveness at and beyond 6 weeks. CLINICALTRIAL ClinicalTrials.gov NCT03032952; https://clinicaltrials.gov/ct2/show/NCT03032952
... However, some would argue that similar effects on empowerment would be seen after any kind of supportive, digital encounter with a patient. Indeed, awareness of the digital placebo effect is important, as positive outcomes have been found from a patient just using a smart device for health purposes (44). Interestingly, patients in our video-group experienced nonsignificant higher levels of empowerment compared to patients in the telephone-group which differs from the findings in a systematic review where most studies did not show differences between telephone and video appointments (18). ...
Article
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This study reports the process and preliminary findings of rapid implementation of telegenetic counseling in the context of Swedish healthcare and COVID-19 pandemic, from both a patient and a provider perspective. Fourty-nine patients and 6 healthcare professionals were included in this feasibility study of telegenetic counseling in a regional Department of Clinical Genetics in Sweden. Telegenetic counseling is here defined as providing genetic counseling to patients by video (n = 30) or telephone (n = 19) appointments. Four specific feasibility aspects were considered: acceptability, demand, implementation, and preliminary efficacy. Several measures were used including the Genetic Counseling Outcome Scale 24 (collected pre- and post-counseling); the Telehealth Usability Questionnaire; a short study specific evaluation and Visiba Care evaluations, all collected post-counseling. The measures were analyzed with descriptive statistics and the preliminary results show a high level of acceptance and demand, from both patients and providers. Results also indicate successful initial implementation in the regional Department of Clinical Genetics and preliminary efficacy, as shown by significant clinically important improvement in patients' empowerment levels.
... The links and references should be analyzed the ensure the app strives for net benefit and does not misrepresent facts. In addition, an assessment of clinical foundation should consider both that apps appearing to be effective in research contexts may perform differently in the real world and evidence of app effectiveness may be inflated by the digital placebo effect, by which users report improvements in symptoms when using any digital product, regardless of whether the piece of technology in use is a digital intervention or merely a control 31 . Overall, studies with an active control group involving a digital control may better represent actual app effectiveness; however, given the various concerns, a With beneficence in mind, the framework at this level poses questions about the app's alignment with its claims, as well as evidence of specific benefit from academic institutions, publications, end user feedback, or research studies. ...
Article
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As use and availability of mobile health apps have increased, so too has the need for a thorough, accessible framework for app evaluation. The American Psychiatric Association’s app evaluation model has emerged as a way to critically assess an app by considering accessibility, privacy and security, clinical foundation, engagement, and interoperability; however, there is no centralized database where users can view how various health apps perform when assessed via the APA model. In this perspective, we propose and outline our effort to translate the APA’s model for the evaluation of health apps into a set of objective metrics that can be published online, making the framework actionable and accessible to a broad audience. The questions from the APA model were operationalized into 105 objective questions that are either binary or numeric. These questions serve as the foundation of an online database, where app evaluation consists of answering these 105 questions and can be crowdsourced. While the database has yet to be published and crowdsourced, initial internal testing demonstrated excellent interrater reliability. The database proposed here introduces a public and interactive approach to data collection that is guided by the APA model. The published product enables users to sort through the many mobile health apps and filter them according to individual preferences and priorities, making the ever-growing health app market more navigable.
... Future studies should investigate: (1) at what stage apps are most effective (e.g., prevention); (2) whether findings can be replicated in patients with more severe psychopathologies; (3) whether benefits can be sustained in the long-term; (4) what specific features of the app contribute to psychological changes; and (5) whether improvements can be attributed to individuals' expectations of apps. This phenomenon, coined the digital placebo effect, is an overlooked area which also merits future investigation (49). ...
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Background: Limited evidence suggests that mobile mood-monitoring can improve mental health outcomes and therapeutic engagement in young people. The aim of this mixed methods study was to explore the clinical impacts of mobile mood-monitoring in youth with mental health problems, using a publicly accessible app. Methods: Twenty-three patients with mental health problems and 24 young people without mental health problems participated in the quantitative study. Participants monitored their mood using a mood-monitoring app twice a day for 3 weeks, which was preceded by a 3-week baseline period. Outcome measures included momentary and retrospective assessments of affect regulation (all participants) and therapeutic engagement (patients only). Following the quantitative study, patients ( n = 7) and their clinicians ( n = 6) participated in individual interviews. Interview data was analysed using thematic analysis. Results: Use of the mood-monitoring app significantly reduced momentary negative mood ( p < 0.001) and retrospectively assessed impulsivity across all 47 participants ( p = 0.001). All other outcomes showed no significant difference. Qualitative feedback similarly indicated the potential of apps to improve problems with impulsivity in patients. Furthermore, apps may aid communication, promote empowerment, and ameliorate memory difficulties in clinical appointments. Conclusions: This mixed methods study demonstrated the potential utility of apps for clinical practice. Apps may potentially be an interventional tool, or at a minimum, an adjunct to existing treatments. Data was collected from a small sample size over a short study duration, limiting the generalisability of findings and inferences regarding long-term effects. Potential sources of bias in the qualitative study (e.g., researcher bias) should also be considered.
... There are studies, that report results on feasibility of digital intervention and users' satisfaction (Dennison et al., 2013;Terp et al., 2018;Wartena & van Dijk, 2013), which requires further investigations of clinical efficacy. Representativity of clinical effects in another studies is a challenge due to a low number of participants (only six technologies were tested on more than 100 participants; Bain et al., 2017;Berrouiguet et al., 2017;Španiel et al., 2012), lack comparisons with control group or 'digital placebo' effect (Torous & Firth, 2016) and unknown efficacy of long-term follow-up. ...
Article
Background: Various types of computational technologies can be used to access, store and wirelessly share private and sensitive user-related information. The 'big data' provided by these technologies may enable researchers and clinicians to better identify behavioral patterns and to provide a more personalized approach to care. The information collected, however, can be misused or potentially abused, and therefore could be detrimental to the very people who provided their medical data with the hope of improving care. This article focuses on the use of emerging mobile technologies that allow the collection of data about patients experiencing schizophrenia spectrum and related disorders. Schizophrenia has been recognized by the Sustainable Development Goals of the United Nations for its burden on our health care system and society [1]. Our analysis provides an overview of the range of available mobile technologies for people with schizophrenia and related conditions along with the technology's reported capabilities and limitations, and efficacy of mHealth interventions based on the data from articles. Thus, the focus of this review is first and foremost to update the scope of existing technologies as previous systematic reviews such as the ones by Alvarez-Jimenez et al. and by Firth and Torous are outdated [2, 3]. Although we also examine the ethical issues arising from the use of these technologies, for an in-depth analysis of the ethical implications of mobile Health technologies (mHealth), we refer the readers to our follow-up article. In terms of the ubiquitous availability of technology on the internet, our article summarizes significant information for mental health specialists and apprises the reader about the existence of these technologies. Objectives: In terms of the ubiquitous availability of technology on the internet, our article summarizes significant information for mental health specialists and apprises the reader about the existence of these technologies.
... At present, 81% of the US population own a smartphone, a rate that has more than doubled since 2011 [8]. Not surprisingly, therefore, there is mounting enthusiasm among clinical researchers for developing and deploying smartphone CBT treatments [9,10]. ...
Preprint
BACKGROUND Smartphone-delivered cognitive behavioral therapy (CBT) is becoming more common, but research on the topic remains in its infancy. Little is known about how people typically engage with smartphone CBT or which engagement and mobility patterns may optimize treatment. Passive smartphone data offer a unique opportunity to gain insight into these knowledge gaps. OBJECTIVE This study aimed to examine passive smartphone data across a pilot course of smartphone CBT for body dysmorphic disorder (BDD), a psychiatric illness characterized by a preoccupation with a perceived defect in physical appearance, to inform hypothesis generation and the design of subsequent, larger trials. METHODS A total of 10 adults with primary diagnoses of BDD were recruited nationally and completed telehealth clinician assessments with a reliable evaluator. In a 12-week open pilot trial of smartphone CBT, we initially characterized natural patterns of engagement with the treatment and tested how engagement and mobility patterns across treatment corresponded with treatment response. RESULTS Most participants interacted briefly and frequently with smartphone-delivered treatment. More frequent app usage ( r =–0.57), as opposed to greater usage duration ( r =–0.084), correlated strongly with response. GPS-detected time at home, a potential digital marker of avoidance, decreased across treatment and correlated moderately with BDD severity ( r =0.49). CONCLUSIONS The sample was small in this pilot study; thus, results should be used to inform the hypotheses and design of subsequent trials. The results provide initial evidence that frequent (even if brief) practice of CBT skills may optimize response to smartphone CBT and that mobility patterns may serve as useful passive markers of symptom severity. This is one of the first studies to examine the value that passively collected sensor data may contribute to understanding and optimizing users’ response to smartphone CBT. With further validation, the results can inform how to enhance smartphone CBT design.
... At present, 81% of the US population own a smartphone, a rate that has more than doubled since 2011 [8]. Not surprisingly, therefore, there is mounting enthusiasm among clinical researchers for developing and deploying smartphone CBT treatments [9,10]. ...
Article
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Background Smartphone-delivered cognitive behavioral therapy (CBT) is becoming more common, but research on the topic remains in its infancy. Little is known about how people typically engage with smartphone CBT or which engagement and mobility patterns may optimize treatment. Passive smartphone data offer a unique opportunity to gain insight into these knowledge gaps. Objective This study aimed to examine passive smartphone data across a pilot course of smartphone CBT for body dysmorphic disorder (BDD), a psychiatric illness characterized by a preoccupation with a perceived defect in physical appearance, to inform hypothesis generation and the design of subsequent, larger trials. Methods A total of 10 adults with primary diagnoses of BDD were recruited nationally and completed telehealth clinician assessments with a reliable evaluator. In a 12-week open pilot trial of smartphone CBT, we initially characterized natural patterns of engagement with the treatment and tested how engagement and mobility patterns across treatment corresponded with treatment response. Results Most participants interacted briefly and frequently with smartphone-delivered treatment. More frequent app usage (r=–0.57), as opposed to greater usage duration (r=–0.084), correlated strongly with response. GPS-detected time at home, a potential digital marker of avoidance, decreased across treatment and correlated moderately with BDD severity (r=0.49). Conclusions The sample was small in this pilot study; thus, results should be used to inform the hypotheses and design of subsequent trials. The results provide initial evidence that frequent (even if brief) practice of CBT skills may optimize response to smartphone CBT and that mobility patterns may serve as useful passive markers of symptom severity. This is one of the first studies to examine the value that passively collected sensor data may contribute to understanding and optimizing users’ response to smartphone CBT. With further validation, the results can inform how to enhance smartphone CBT design.
... We feel RCTs comparing mHealth apps to normal practice (eg, in-person follow-up, telephone follow-up, or no follow-up) would be particularly beneficial in assessing the domains of satisfaction and usefulness. It has also been suggested that mHealth app interventions are associated with a falsely heightened level of user satisfaction due to patients' affinities for their digital devices [62]. This could be minimized by comparing postoperative mHealth apps to a sham app. ...
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Background Mobile health (mHealth) apps are increasingly used postoperatively to monitor, educate, and rehabilitate. The usability of mHealth apps is critical to their implementation. Objective This systematic review evaluates the (1) methodology of usability analyses, (2) domains of usability being assessed, and (3) results of usability analyses. Methods The A Measurement Tool to Assess Systematic Reviews checklist was consulted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline was adhered to. Screening was undertaken by 2 independent reviewers. All included studies were assessed for risk of bias. Domains of usability were compared with the gold-standard mHealth App Usability Questionnaire (MAUQ). Results A total of 33 of 720 identified studies were included for data extraction. Of the 5 included randomized controlled trials (RCTs), usability was never the primary end point. Methodology of usability analyses included interview (10/33), self-created questionnaire (18/33), and validated questionnaire (9/33). Of the 3 domains of usability proposed in the MAUQ, satisfaction was assessed in 28 of the 33 studies, system information arrangement was assessed in 11 of the 33 studies, and usefulness was assessed in 18 of the 33 studies. Usability of mHealth apps was above industry average, with median System Usability Scale scores ranging from 76 to 95 out of 100. Conclusions Current analyses of mHealth app usability are substandard. RCTs are rare, and validated questionnaires are infrequently consulted. Of the 3 domains of usability, only satisfaction is regularly assessed. There is significant bias throughout the literature, particularly with regards to conflicts of interest. Future studies should adhere to the MAUQ to assess usability and improve the utility of mHealth apps.
... Furthermore, most users who wrote comments found the apps to be beneficial (median = 76.2%), and app usage was similar to that of evidence-based apps in most cases. The question is if users' positive experiences can be attributed to a digital placebo effect (Torous and Firth, 2016). According to Torous and Firth, many people place positive expectations on the capability of mobile devices and the apps stored on them; it could be that the high levels of expectation, trust, and personalization intrinsic to these devices or apps causes such an effect. ...
Article
Background Recent studies have utilized available online data to examine the impact of depression- and anxiety-related apps that incorporate evidence-based techniques; however, the impact of apps incorporating non-evidence-based techniques is unknown. Understanding this impact is important in order to assess the potential benefits or harm from their use. Methods We systematically reviewed apps incorporating relevant techniques aimed at depression- and anxiety-related conditions, found through Google Play search. We conducted quantitative and qualitative analyses of user reviews, and analyzed app usage utilizing an independent user panel. Results Compared to apps incorporating evidence-based techniques (n=14), user ratings of apps classified as non-evidence-based (n=27) were lower (4.0 versus 4.5, p=.001, η²=.24) and a smaller percentage of users found these apps to be beneficial for mental health (76.2% versus 100%, p=.003, η²=.23). Users found apps incorporating non-evidence-based techniques to be mostly helpful in providing in-the-moment relief; however, some users described these apps as containing content that could be harmful for a person in such a mental state. Limitations The data do not enable the differentiation of user experiences based on user groups (e.g. according to the severity of symptoms), which should be examined in future studies. Conclusions This study indicates that depression and anxiety apps incorporating non-evidence-based techniques are viewed less favorably and have more potential to cause harm. However, many users found them helpful mostly in providing in-the-moment relief. Examining user experiences with these apps is an important way to learn about unmet user needs and potential benefits or harm.
... Investigations of the design principles behind these functionalities are critical because patients with mental illness are often sensitive to personal health information collected and shown by apps [97]. Poor design also leads to poor adherence, with most end users stopping using an app two weeks after download [113]. For ED patients, in particular, placing attention on one's eating or weight may trigger symptoms, relapses, and even denial of one's condition [87]. ...
Conference Paper
Eating disorders (EDs) constitute a mental illness with the highest mortality. Today, mobile health apps provide promising means to ED patients for managing their condition. Apps enable users to monitor their eating habits, thoughts, and feelings, and offer analytic insights for behavior change. However, not only have scholars critiqued the clinical validity of these apps, their underlying design principles are not well understood. Through a review of 34 ED apps, we uncovered 11 different data types ED apps collect, and 9 strategies they employ to support collection and reflection. Drawing upon personal health informatics and visualization frameworks, we found that most apps did not adhere to best practices on what and how data should be collected from and reflected to users, or how data-driven insights should be communicated. Our review offers suggestions for improving the design of ED apps such that they can be useful and meaningful in ED recovery.
... [7][8][9][10][11] Additionally, nonspecific factors are associated with patients' engagement in the therapeutic process such as invested time and effort [12][13][14][15] and adherence to the treatment regimen (e.g., homework assignments). 16,17 So far, nonspecific factors have largely been neglected in the e-health literature 18,19 and their effects remain unknown. To optimize the effectiveness of applied games to its best potential, it is crucial to examine and harness the benefits of nonspecific factors. ...
Article
Objective: Applied games are considered a promising approach to deliver mental health interventions. Nonspecific factors such as expectations and motivation may be crucial to optimize effectiveness yet have not been examined so far. The current study examined the effect of expectations for improvement on (1) experienced fun and positive affect, and (2) in-game play behaviors while playing MindLight, an applied game shown to reduce anxiety. The secondary aim was to examine the moderating role of symptom severity and motivation to change. Materials and Methods: Fifty-seven participants (47 females; 17-21 years old) preselected on anxiety symptoms viewed a trailer in which MindLight was promoted as either a mental health or an entertainment game. These trailers were used to induce different expectations in participants. Participants subsequently played the game for 60 minutes. Before playing, participants filled out questionnaires about their general anxiety symptoms, motivation to change, state anxiety, affect, and arousal. While playing, in-game behaviors and galvanic skin response (GSR) were recorded continuously. After playing, state anxiety, affect, and arousal were measured again as well as experienced fun. Results: Participants in both trailer conditions showed increases in state anxiety, arousal, and GSR. Expectations did not influence experienced fun and positive affect, nor in-game behaviors. In addition, no moderation effects of motivation to change and symptom severity were found. Conclusion: Experiences and engagement with MindLight were not influenced by expectations, motivation to change, and symptom severity. For future research, it is recommended to examine individual differences in these effects, and long-term and more distal outcomes and processes.
... Sources of high risk of bias in the RCTs included failure to blind participants and personnel to the online intervention and inadequate reporting of allocation concealment. Failing to blind participants, which can be difficult in online intervention studies, can lead to the "digital placebo effect" (Torous and Firth, 2016). One possible way of mediating this effect in future studies is to create a sham or static online program for control groups, therefore, reducing the risk of the digital placebo effect. ...
Article
Background: Tic disorder is a highly debilitating condition that is more common in children and young people (CYP) than adults. A parent and therapist-supported intervention called Online Remote Behavioural Intervention for Tics (ORBIT) was developed to meet the demand for behavioural therapy for CYP with tic disorders. Whilst a randomised controlled trial (RCT) assesses overall efficacy, a process evaluation is necessary to establish how and for whom an intervention works. Methods: First, a systematic review and meta-analysis was conducted to assess the overall effectiveness of online interventions delivered to CYP with neurodevelopmental disorders (NDDs). Following this, the Medical Research Council’s (MRC) 2015 guidelines were used for this two-part mixed-methods process evaluation. This involved analysing quantitative data, such as participants’ usage of the intervention and baseline demographics as well as purposively sampled, semi-structured interviews. The first part explored the implementation and contextual factors of engagement whilst the second part analysed the mechanisms of impact underpinning the ORBIT intervention. Results: A systematic review of 10 trials found that six (two aimed at tic disorders) were effective in improving outcomes in CYP. Part one of the process evaluation found the intervention was implemented with high fidelity, and participants deemed the intervention acceptable and satisfactory. Engagement was high with child participants completing an average of 7.5/10 chapters and 99/112 (88.4%) participants completing the minimum of first four chapters: the pre-defined threshold for effective dose. Parental engagement was the only significant independent predictor of child engagement. Part two demonstrated reduced tic severity post intervention and 36% of CYP had their overall clinical condition rated as being very much or much improved post-treatment. Improvement was not moderated by the relationship between demographic or baseline clinical factors and engagement and no mediators were found. However, level of parental engagement was associated with overall clinical improvement and this relationship was illuminated by the qualitative data. Conclusions: The findings provide promising evidence that an online behavioural intervention is acceptable and accessible amongst CYP with tic disorders, and engaging parents is the key to effective implementation and positive outcomes whilst highlighting that there is no particular subgroup that is more or less likely to engage or to find this treatment beneficial.
... This concept was discussed in a previously published study that suggested that mobile apps create a digital placebo effect on patient and the beliefs about technology support and perceptions of being constantly connected with health care providers lead to clinical improvements. 29 Therefore, future studies could explore this digital placebo effect to ensure medication adherence by app interventions. Overall, future studies should use evidence-based measures and meticulously plan the clinical study protocols to assess the effectiveness of mobile apps in enhancing medication adherence among the T2DM patients. ...
Article
Background Medication adherence in type 2 diabetes mellitus (T2DM) patients is often suboptimal resulting in complications. There has been a growing interest in using mobile apps for improving medication adherence. Objective The objective of this work was to systematically review the clinical trials that have used mobile app–based interventions in T2DM patients for improving medication adherence. Methodology A systematic search was performed to identify published clinical trials between January 2008 and December 2020 in databases—PubMed, Cochrane Library, and Google Scholar. All studies were assessed for risk of bias using quality rating tool from the Cochrane Handbook for Systematic Reviews of Interventions. Results Seven clinical studies having 649 participants were studied. The median sample size was 58 (range = 41-247) and the median age of participants was 53.2 (range = 48-69.4) years. All studies showed improvements in adherence; however, only three studies reported statically significant improvements in adherence measures. Selected studies were deemed as unclear in their risk of bias and the most common source of risk of bias among the studies was the absence of objective outcome assessment. Conclusions Mobile apps appear to be effective interventions to help improve medication adherence in T2DM patients compared with conventional care strategies. The features of the App to improvise medical adherence cannot be defined based on the meta-analysis because of heterogeneity of study designs and less number of sample size. Systematically planned studies would set up applicability of mobile apps in the clinical management of T2DM.
... Furthermore, the Hawthorne effect warns for the effects of awareness of conscious observation, as it can be manipulated accordingly and, therefore, considered an intervention already. This applies to digital phenotyping and induces biases accordingly, e.g., registration of mood symptoms, already affects mood symptoms through increased self-awareness ( Victory et al., 2020 ) and even induce a digital placebo-effect ( Torous and Firth, 2016 ). Also, the medium used is not neutral. ...
Article
Depression is an invalidating disorder, marked by phenotypic heterogeneity. Clinical assessments for treatment adjustments and data-collection for pharmacological research often rely on subjective representations of functioning. Better phenotyping through digital applications may add unseen information and facilitate disentangling the clinical characteristics and impact of depression and its pharmacological treatment in everyday life. Researchers, physicians, and patients benefit from well-understood digital phenotyping approaches to assess the treatment efficacy and side-effects. This review discusses the current possibilities and pitfalls of wearables and technology for the assessment of the pharmacological treatment of depression. Their applications in the whole spectrum of treatment for depression, including diagnosis, treatment of an episode, and monitoring of relapse risk and prevention are discussed. Multiple aspects are to be considered, including concerns that come with collecting sensitive data and health recordings. Also, privacy and trust are addressed. Available applications range from questionnaire-like apps to objective assessment of behavioural patterns and promises in handling suicidality. Nonetheless, interpretation and integration of this high-resolution information with other phenotyping levels, remains challenging. This review provides a state-of-the-art description of wearables and technology in digital phenotyping for monitoring pharmacological treatment in depression, focusing on the challenges and opportunities of its application in clinical trials and research.
... Although Franklin and colleagues [16] did also use a control application, there is no evidence to suggest it mirrored the intervention program. By creating a robust digital placebo, we were able to test whether the therapeutic content contributed to improvements in key outcomes above and beyond participant expectations about LifeBuoy (i.e., the digital placebo effect) [39]. The potential for the digital placebo effect to influence efficacy is demonstrated in a prior study of a smartphone application for adolescents to self-monitor symptoms of depression; the study found that without any direct therapeutic intervention, self-monitoring significantly reduced symptoms [40]. ...
Article
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Background Suicidal ideation is a major risk for a suicide attempt in younger people, such that reducing severity of ideation is an important target for suicide prevention. Smartphone applications present a new opportunity for managing ideation in young adults; however, confirmatory evidence for efficacy from randomized trials is lacking. The objective of this study was to assess whether a therapeutic smartphone application (“LifeBuoy”) was superior to an attention-matched control application at reducing the severity of suicidal ideation. Methods and findings In this 2-arm parallel, double-blind, randomized controlled trial, 455 young adults from Australia experiencing recent suicidal ideation and aged 18 to 25 years were randomly assigned in a 2:2 ratio to use a smartphone application for 6 weeks in May 2020, with the final follow-up in October 2020. The primary outcome was change in suicidal ideation symptom severity scores from baseline (T0) to postintervention (T1) and 3-month postintervention follow-up (T2), measured using the Suicidal Ideation Attributes Scale (SIDAS). Secondary outcomes were symptom changes in depression (Patient Health Questionnaire-9, PHQ-9), generalized anxiety (Generalized Anxiety Disorder-7, GAD-7), distress (Distress Questionnaire-5, DQ5), and well-being (Short Warwick–Edinburgh Mental Well-Being Scale, SWEMWBS). This trial was conducted online, using a targeted social media recruitment strategy. The intervention groups were provided with a self-guided smartphone application based on dialectical behavior therapy (DBT; “LifeBuoy”) to improve emotion regulation and distress tolerance. The control group were provided a smartphone application that looked like LifeBuoy (“LifeBuoy-C”), but delivered general (nontherapeutic) information on a range of health and lifestyle topics. Among 228 participants randomized to LifeBuoy, 110 did not complete the final survey; among 227 participants randomized to the control condition, 91 did not complete the final survey. All randomized participants were included in the intent-to-treat analysis for the primary and secondary outcomes. There was a significant time × condition effect for suicidal ideation scores in favor of LifeBuoy at T1 ( p < 0.001, d = 0.45) and T2 ( p = 0.007, d = 0.34). There were no superior intervention effects for LifeBuoy on any secondary mental health outcomes from baseline to T1 or T2 [ p -values: 0.069 to 0.896]. No serious adverse events (suicide attempts requiring medical care) were reported. The main limitations of the study are the lack of sample size calculations supporting the study to be powered to detect changes in secondary outcomes and a high attrition rate at T2, which may lead efficacy to be overestimated. Conclusions LifeBuoy was associated with superior improvements in suicidal ideation severity, but not secondary mental health outcomes, compared to the control application, LifeBuoy-C. Digital therapeutics may need to be purposefully designed to target a specific health outcome to have efficacy. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12619001671156
... LifeBuoy-C was used to control for a potential digital placebo effect seen in a trial of smartphone interventions. 23 The control intervention was designed to provide information for young people that matched the intervention in terms of duration and attention without providing any proven therapeutic content. As with LifeBuoy, each module will take 10 or more minutes to complete. ...
Article
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Introduction Youth suicidal ideation and behaviour is concerning due to its widespread prevalence, morbidity and potentially fatal consequences. Digital mental health interventions have been found to improve access to low-cost and high-quality support for a range of mental health issues, yet there are few digital interventions available for suicide prevention in young people. In addition, no studies have examined how digital engagement strategies may impact the engagement and efficacy of digital interventions in suicide prevention. The current protocol describes a three-arm parallel randomised controlled trial. A therapeutic smartphone application (‘LifeBuoy’; intervention condition) will be tested against a condition that consists of the LifeBuoy application plus access to a digital engagement strategy (‘LifeBuoy+engagement’; intervention condition) to determine whether the addition of the digital strategy improves app engagement metrics. To establish the efficacy of the LifeBuoy application, both of these intervention conditions will be tested against an attention-matched control condition (a placebo app). Methods and analysis 669 young Australians aged 17–24 years who have experienced suicidal ideation in the past 30 days will be recruited by Facebook advertisement. The primary outcomes will be suicidal ideation severity and level of app engagement. Primary analyses will use an intention-to-treat approach and compare changes from baseline to 30-day, 60-day and 120-day follow-up time points relative to the control group using mixed-effect modelling. A subset of participants in the intervention groups will be interviewed on their experience with the app and engagement strategy. Qualitative data will be analysed using an inductive approach, independent of a theoretical confirmative method to identify the group themes. Ethics and dissemination The study has been approved by the University of New South Wales Human Research Ethics Committee (HC210400). The results of the trial will be disseminated via peer-reviewed publications in scientific journals and conferences. Trial registration number ACTRN12621001247864.
... In addition, we hope our results sensitize both clinical trialists and meta-analysts to the importance of considering the comparison condition (for an exemplary meta-analytic treatment of comparison type, see Linardon et al. [21]). This literature would be strengthened through more studies including active and ideally specific active controls which are capable of identifying key intervention ingredients and disentangling intervention-specific elements from the effect of expectancy and other non-specific factors alone (although these non-specific elements are likely an important component worthy of study in their own right [64,65]). The quality of the primary study literature would be improved through the use of objective measures (to reduce bias due to unblinded outcome assessors), use of intention-to-treat analyses (to reduce bias due to incomplete outcome data), and preregistration of outcomes (to reduce selective reporting bias). ...
Article
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Mobile phone-based interventions have been proposed as a means for reducing the burden of disease associated with mental illness. While numerous randomized controlled trials and meta-analyses have investigated this possibility, evidence remains unclear. We conducted a systematic meta-review of meta-analyses examining mobile phone-based interventions tested in randomized controlled trials. We synthesized results from 14 meta-analyses representing 145 randomized controlled trials and 47,940 participants. We identified 34 effect sizes representing unique pairings of participants, intervention, comparisons, and outcome (PICO) and graded the strength of the evidence as using umbrella review methodology. We failed to find convincing evidence of efficacy (i.e., n > 1000, p < 10 ⁻⁶ , I ² < 50%, absence of publication bias); publication bias was rarely assessed for the representative effect sizes. Eight effect sizes provided highly suggestive evidence (i.e., n > 1000, p < 10 ⁻⁶ ), including smartphone interventions outperforming inactive controls on measures of psychological symptoms and quality of life ( d s = 0.32 to 0.47) and text message-based interventions outperforming non-specific controls and active controls for smoking cessation ( d s = 0.31 and 0.19, respectively). The magnitude of effects and strength of evidence tended to diminish as comparison conditions became more rigorous (i.e., inactive to active, non-specific to specific). Four effect sizes provided suggestive evidence, 14 effect sizes provided weak evidence, and eight effect sizes were non-significant. Despite substantial heterogeneity, no moderators were identified. Adverse effects were not reported. Taken together, results support the potential of mobile phone-based interventions and highlight key directions to guide providers, policy makers, clinical trialists, and meta-analysts working in this area.
... Fewer studies have conducted rigorous tests of whether chatbots lead to improvements in mental health outcomes, and most research conducted in this domain consists of single-arm studies with no control groups, or studies with control groups that may not be adequate placebo or attention-controls. This is particularly important given that some researchers have argued that individual features of DMHIs, such as the availability of chatbots, may be associated with a greater digital placebo effect [106]. For example, although one meta-analysis found chatbots were effective for improving depression, distress, stress, and acrophobia, their evidence was considered weak due to the lack of studies, conflicting results across studies, and high estimated risk of bias in the included studies [107]. ...
Article
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Introduction Increasing demand for mental health services and the expanding capabilities of artificial intelligence (AI) in recent years has driven the development of digital mental health interventions (DMHIs). To date, AI-based chatbots have been integrated into DMHIs to support diagnostics and screening, symptom management and behavior change, and content delivery. Areas covered We summarize the current landscape of DMHIs, with a focus on AI-based chatbots. Happify Health’s AI chatbot, Anna, serves as a case study for discussion of potential challenges and how these might be addressed, and demonstrates the promise of chatbots as effective, usable, and adoptable within DMHIs. Finally, we discuss ways in which future research can advance the field, addressing topics including perceptions of AI, the impact of individual differences, and implications for privacy and ethics. Expert opinion Our discussion concludes with a speculative viewpoint on the future of AI in DMHIs, including the use of chatbots, the evolution of AI, dynamic mental health systems, hyper-personalization, and human-like intervention delivery.
... A further complication in evaluating apps which target specific behaviors is difficulty separating reinforcement of the target behavior once it has commenced versus reinforcement of the behavior which is provided (i.e., initiated) by the app. Moreover, commentators in this field have highlighted the need to elucidate the role of a potential "digital placebo effect" (Torous & Firth, 2016) in clouding the picture of the effectiveness of mental health apps. Finally, trials evaluating apps are often characterized by low rates of overall usage and particularly longer term retention (Torous et al., 2019). ...
Article
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Emergency services are under enormous pressure to offer programmes that could protect their staff from the psychological impact of stressors encountered in their roles. There has been a surge in the number of pre-incident training programmes aimed at first responders to maintain their psychological wellbeing after critical incidents. These include pre-employment screening programmes, psychoeducation, operational training, line manager training and interventions aimed at improving resilience, wellbeing or stress management. Whilst developed with the best intentions, these programmes vary in efficacy. Therefore, knowing what training to offer first responders prior to exposure to critical incidents is far from clear. In this review, we critique the available evidence and make recommendations about what to offer and what to avoid offering first responders prior to exposure to critical incidents. We found no evidence of the effectiveness of pre-employment screening or psychoeducation offered as a standalone package, and little evidence for interventions aimed to improve wellbeing and resilience to stress - although current trials of empirically-driven interventions for first responders are underway and show promise in preventing stress-related psychopathology. Operational and line manager training showed the most promise but need to be evaluated in high quality trials with sufficient follow-up to draw conclusions about their preventative benefits.
... Positive mood significantly increased and negative mood significantly decreased across the 10-day intervention for participants in both the experimental and active control conditions, beginning largely on Days 9 and 10 of the intervention. These results may be reflective of the phenomenon known as digital placebo effects, by which benefits are derived from regular engagement with a digital device or app rather than from the intervention itself (Torous and Firth, 2016). As such, these findings may highlight the importance of utilizing active control conditions in studies assessing the effects of mobile apps. ...
Article
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Mobile mindfulness interventions represent a promising alternative to traditional in-person interventions that are resource demanding and have limited accessibility, preventing use by many populations. Despite greater accessibility and popularity of mobile mindfulness applications (apps), research is needed testing the effectiveness of brief interventions delivered via these platforms. The present study assessed the efficacy of a brief mobile mindfulness intervention compared to an active control for increasing state and trait mindfulness and improving mood, as well as the acceptability of the app, in a sample of undergraduate students. Participants ( N =139; M age =19.43years, 80.6% female, 83.5% White) were randomly assigned to either a 10-day mobile mindfulness (Headspace) or cognitive training (Peak) condition. Trait mindfulness was measured pre- and post-intervention. During the 10-day intervention, participants completed 10-min daily exercises on the assigned app, responded to daily questionnaires of state mindfulness and mood, and completed a daily written log of their reactions to the app exercises. Attrition was low (90% completion rate) and did not differ by condition. Participants in the mindfulness condition spent an average of 88.15min ( SD =24.75) meditating out of the full 100min prescribed by the intervention. State mindfulness significantly increased across the 10-day intervention for participants in the mindfulness, but not the cognitive training, condition beginning around days 5 and 6. Some aspects of trait mindfulness increased and mood improved from pre- to post-intervention, but these changes were observed in both conditions (i.e., no significant differences were observed by condition). Qualitative analysis of open-ended reactions to the mindfulness app indicated that participants reported more likes than dislikes. Common themes for likes were that participants experienced feelings of calm and focus following the daily mindfulness exercises. Dislikes included discomfort and anxiety associated with increased awareness of thoughts and physical sensations. These findings suggest that while a brief mobile mindfulness intervention is acceptable to undergraduate college students and effective at increasing state mindfulness, a longer intervention may be needed in order to elicit corresponding changes in trait-level mindfulness or mood.
Article
High quality mobile health applications (mhealth apps) have the potential to enhance the prevention, diagnosis and treatment of burns. The primary aim of this study was to evaluate whether the quality of mhealth apps for burns care is being adequately assessed. The secondary aim was to determine whether these apps meet regulatory standards in the UK. We searched AMED, BNI, CINAHL, Cochrane library, Embase, Emcare, Medline and PsychInfo to identify studies assessing mhealth app quality for burns. The PRISMA reporting guideline was adhered to. Two independent reviewers screened abstracts to identify relevant studies. The quality of identified studies was assessed according to the framework proposed by Nouri et al, including design, information/content, usability, functionality, ethical issues, security/privacy and user-perceived value. Of the 28 included studies, none assessed all seven domains of quality. Design was assessed in 4/28 studies; information/content in 26/28 studies; usability in 12/28 studies; functionality in 10/28 studies; ethical issues were never assessed in any studies; security/privacy was not assessed; subjective assessment was made in 9/28 studies. 17/28 studies included apps that met the definition of ‘medical device’ according to MHRA guidance, yet only one app was appropriately certified with the UK Conformity Assessed (UKCA) mark. The quality of mHealth apps for burns are not being adequately assessed. The majority of apps should be considered medical devices according to UK standards, yet only one was appropriately certified. Regulatory bodies should support mhealth app developers, so as to improve quality control whilst simultaneously fostering innovation.
Article
Objective: Apps purporting to assist with the management of eating disorders are proliferating; although less is known about (a) the safety or efficacy of the apps on the marketplaces and (b) if the research evidence supports dissemination of these apps. In this research forum, we seek to synthesize the current data and provide practical considerations around the use and research of these apps. Methods: A search of the iOS and Google Play stores was conducted in June 2021 to identify publicly available apps targeting eating disorders. A PubMed search was also conducted in June 2021 to identify relevant publications around smartphone apps for eating disorders. Results: Sixty-five apps that support the treatment of eating disorders were identified and coded across 105 data points on the publicly available mindApps.org website. The literature search revealed 13 articles. Seven percent of marketplaces apps offered any research support and the 13 published studies focused on only four apps. Discussion: There is a need for more translational research on smartphone apps for eating disorders. Current marketplace offerings present risks that may not be balanced by their limited evidence. Research efforts should focus on offering evidenced-based apps for the marketplace. Clinicians should weigh known and emerging risks and benefits of these apps within the context of research gaps when making decisions around use.
Article
Clinical and research interest in the potential of mobile health apps for the management of mental health conditions has recently been given added impetus by growing evidence of consumer adoption. In parallel, there is now a developing evidence base that includes meta-analyses demonstrating reductions in symptoms of depression and anxiety, and reduction in suicidal ideation. While these findings are encouraging, recent research continues to identify a number of potential barriers to the widespread adoption of mental health apps. These challenges include poor data governance and data sharing practices; questions of clinical safety relating to the management of adverse events and potentially harmful content; low levels of user engagement and the possibility of ‘digital placebo’ effects; and workforce barriers to integration with clinical practice. Current efforts to address these include the development of new models of care, such as ‘digital clinics’ that integrate health apps. Other contemporary innovations in the field such as digital sensing and just-in-time adaptive interventions are showing early promise for providing accessible and personalised care.
Article
Well before COVID-19, there was growing excitement about the potential of various digital technologies such as tele-health, smartphone apps, or AI chatbots to revolutionize mental healthcare. As the SARS-CoV-2 virus spread across the globe, clinicians warned of the mental illness epidemic within the coronavirus pandemic. Now, funding for digital mental health technologies is surging and many researchers are calling for widespread adoption to address the mental health sequelae of COVID-19. Reckoning with the ethical implications of these technologies is urgent because decisions made today will shape the future of mental health research and care for the foreseeable future. We contend that the most pressing ethical issues concern (1) the extent to which these technologies demonstrably improve mental health outcomes and (2) the likelihood that wide-scale adoption will exacerbate the existing health inequalities laid bare by the pandemic. We argue that the evidence for efficacy is weak and that the likelihood of increasing inequalities is high. First, we review recent trends in digital mental health. Next, we turn to the clinical literature to show that many technologies proposed as a response to COVID-19 are unlikely to improve outcomes. Then, we argue that even evidence-based technologies run the risk of increasing health disparities. We conclude by suggesting that policymakers should not allocate limited resources to the development of many digital mental health tools and should focus instead on evidence-based solutions to address mental health inequalities.
Article
Background: Transcranial electrical stimulation (tES) is considered effective and safe for depression, albeit modestly, and prone to logistical burdens when performed in external facilities. Investigation of portable tES (ptES), and potentiation of ptES with remote psychological interventions have shown positive, but preliminary, results. Research design: We report the rationale and design of an ongoing multi-arm, randomized, double-blind, sham-controlled clinical trial with digital features, using ptES and internet-based behavioral therapy (iBT) for major depressive disorder (MDD) (NCT04889976). Methods: We will evaluate the efficacy, safety, tolerability and usability of (1) active ptES + active iBT ("double-active"), (2) active ptES + sham iBT ("ptES-only"), and (3) sham ptES + sham iBT ("double-sham"), in adults with MDD, with a Hamilton Depression Rating Scale - 17 item version (HDRS-17) score ≥ 17 at baseline, during 6 weeks. Antidepressants are allowed in stable doses during the trial. Results: We primarily co-hypothesize changes in HDRS-17 will be greater in (1) "double-active" compared to "ptES-only", (2) "double-active" compared to "double-sham", and (3) "ptES-only" compared to "double-sham". We aim to enroll 210 patients (70 per arm). Conclusions: Our results should offer new insights regarding the efficacy and scalability of combined ptES and iBT for MDD, in digital mental health. Clinical trial registration: NCT04889976.
Article
Background Major Depressive Disorder (MDD) is a common and debilitating mood disorder. Individuals with MDD are often misdiagnosed or diagnosed in an untimely manner, exacerbating existing functional impairments. Ecological momentary assessment (EMA) involves the repeated sampling of an individual's symptoms within their natural environment and has been demonstrated to assist in illness assessment and characterization. Capturing data in this way would set the stage for improved treatment outcomes and serve as a complementary resource in the management and treatment of depressive symptoms. Methods Online databases PubMed/MedLine and PsycINFO were searched using PRISMA guidelines and combinations of the following keywords: EMA, depression, smartphone app, diagnosing, symptoms, phone, app, ecological momentary assessment, momentary assessment, data mining, unobtrusive, passive data, GPS, sensor. Results A total of nineteen original articles were identified using our search parameters and ten articles met inclusion criteria for full-text review. Among the ten relevant studies, three studies evaluated feasibility, seven evaluated detection, and three evaluated treatment of MDD. Limitations Limitations include that the design of all of the studies included in this review are non-randomized. It should be noted that most of the studies included were pilot studies and/or exploratory trials lacking a control group. Conclusions Available evidence suggests that the use of passive smartphone-based applications may lead to improved management of depressive symptoms. This review aids creation of new EMA applications, highlights the potential of EMA usage in clinical settings and drug development, emphasizes the importance for regulation of applications in the mental health field, and provides insight into future directions.
Article
Background Self-guided interventions may complement and overcome obstacles to in-person treatment options. The efficacy of app interventions targeting posttraumatic stress disorder (PTSD) is unclear, and results from previous studies on PTSD Coach—an app for managing trauma-related distress—are inconsistent. Objective This study investigates whether access to the Swedish version of the PTSD Coach affects posttraumatic stress, depressive, and somatic symptoms. In addition, we aim to assess the perceived helpfulness, satisfaction, negative effects, response, and remission related to PTSD Coach. Methods Adults who had experienced potentially traumatic events in the past 2 years were randomized (1:1) to have access to PTSD Coach (n=89) or be on the waitlist (n=90). We assessed clinical characteristics at baseline (semistructured interviews and self-rating scales) and after 3 months (self-rating scales). We analyzed the data in R software using linear mixed effects models, chi-square tests, and Fisher exact test. Results Intention-to-treat analyses indicated that access to PTSD Coach decreased posttraumatic stress and depressive symptoms but not somatic symptoms. More participants who had access to PTSD Coach responded with clinically significant improvement and fewer instances of probable PTSD after 3 months compared with waitlist controls. Overall, participants found that PTSD Coach was slightly to moderately helpful and moderately satisfactory. Half of the intervention group (36/71, 51%) reported at least one negative reaction related to using PTSD Coach (eg, disappointment with the app or its results, arousal of stress, or distressing memories). Conclusions Using PTSD Coach may trigger symptoms among a few users; however, most of them perceived PTSD Coach as helpful and satisfactory. This study showed that having access to PTSD Coach helped improve psychological trauma-related symptoms. In addition, we have discussed implications for future research and clinical practice. Trial Registration ClinicalTrials.gov NCT04094922; https://clinicaltrials.gov/ct2/show/NCT04094922
Thesis
A doença oncológica é hoje vista como uma doença crónica dada a elevada sobrevivência que lhe está associada. A quimioterapia destaca-se como uma das principais abordagens terapêuticas para o tratamento do cancro, causando nos doentes impactos relevantes, decorrentes da ocorrência de múltiplos sintomas em simultâneo, tanto físicos como psicológicos, muitos deles “sentidos” no domicílio com repercussões significativas no bem-estar e na qualidade de vida da pessoa, fazendo emergir necessidades específicas em cuidados de saúde. Assim, espera-se que a pessoa no seu domicílio, seja capaz de realizar uma autogestão da sintomatologia experienciada, de forma a manter a sua doença e o tratamento, monitorizados e controlados, contribuindo para o sucesso terapêutico e para a prevenção de complicações. Alicerçados nesta problemática, surge esta tese de doutoramento, que se encontra inserida no projeto iGestSaúde: aplicativo de autogestão da doença crónica, cuja finalidade é desenvolver um aplicativo informático, sob a forma de app iGestSaúde: módulo QT, que permita promover, monitorizar e apoiar o processo de autogestão dos sintomas, bem como a gestão do regime terapêutico, das pessoas com doença oncológica, em tratamento de quimioterapia. Para tal, foram delineadas duas etapas: na primeira foram realizadas revisões sistemáticas da literatura com diferentes propósitos, por forma a reunir todo o conhecimento necessário e atual, ao desenvolvimento da segunda etapa do processo de investigação. Assim, nessa primeira etapa, foi possível mapear o conhecimento existente nesta área, explorar as vivências dos doentes durante o processo de autogestão dos sintomas, identificar as app´s desenvolvidas como suporte durante o tratamento de quimioterapia e reunir a evidência disponível acerca da sua utilização. Na segunda etapa, procurou desenvolver-se um modelo base para uma aplicação informática que promova, monitorize e apoie o processo de a autogestão dos sintomas associados ao tratamento de quimioterapia, bem como a gestão do regime terapêutico associado. Durante esta etapa procurou identificar-se um conjunto de orientações terapêuticas de suporte à autogestão dos sintomas: fadiga/inatividade, dispneia, insónia, ansiedade, náuseas/vómitos, mucosite, anorexia, diarreia, obstipação, dor, alopecia, alterações da pele, alterações na sexualidade e distúrbios urinários, na pessoa com doença oncológica, em tratamento de quimioterapia, através da realização de várias revisões integrativas da literatura, para cada um dos sintomas em estudo, recorrendo a várias bases de dados científicas. De seguida, e após ter sido efetuada a organização das orientações terapêuticas em níveis de intervenção no autocuidado adotados (prevenção e tratamento), foi realizado um estudo de Delphi, com o objetivo de consensualizar, com um grupo de peritos, as orientações terapêuticas de suporte à autogestão dos catorze sintomas em estudo. Em continuidade foi realizado um estudo piloto com o objetivo de efetuar uma validação prévia das orientações terapêuticas, com um grupo de pessoas com doença oncológica em tratamento de quimioterapia, recorrendo ao uso do telefone e acompanhando os doentes durante um mês, por forma a validar as orientações terapêuticas preconizadas em função dos níveis de intervenção no autocuidado requeridos. Neste momento está a desenvolver-se o primeiro protótipo da app iGestSaúde: módulo QT, tendo por base todo o percurso de investigação realizado ao longo desta tese, para se poder dar seguimento ao processo de desenvolvimento da mesma, testando genericamente, a sua eficácia e segurança de utilização por parte dos utilizadores. Este não é um processo terminado, pelo que outras funcionalidades estão pensadas para serem desenvolvidas posteriormente. Esperamos que os estudos e o aplicativo que apresentamos, bem como a reflexão acerca dos resultados obtidos, as implicações para o doente, para a clínica, e para a investigação identificados, consigam constituir um ponto de referência para melhor compreender, intervir e investigar o fenómeno da autogestão dos sintomas associados ao tratamento de QT. O conhecimento e a proposta de solução, que aqui apresentamos, pretendem ser uma iniciativa com contributos importantes para a melhoria do conhecimento da disciplina de enfermagem e da excelência do cuidar, não só pela informação emergente, mas também pelo potencial de aplicabilidade em contexto clínico, tendo em vista a melhoria da qualidade de vida e o bem-estar das pessoas com doença oncológica, em tratamento de quimioterapia.
Article
The COVID-19 pandemic has heightened concerns about the impact of depression, anxiety, alcohol, and drug use on public health. Mobile apps to address these problems were increasingly popular even before the pandemic, and may help reach people who otherwise have limited treatment access. In this review, we describe pandemic-related substance use and mental health problems, the growing evidence for mobile app efficacy, how health systems can integrate apps into patient care, and future research directions. If equity in access and effective implementation can be addressed, mobile apps are likely to play an important role in mental health and substance use disorder treatment.
Article
Happiness has become a high‐profile goal for national governments, city authorities and technology developers finding new ways to map and measure emotions through happiness economics, urban management and digital emotion sensing. This paper advances critical geographical analysis of the neglected rationales, mechanisms and implications of promoting the emotion of happiness. Researchers, policy makers and publics alike are intrigued and troubled by how a growing concern with mapping and monitoring human happiness can co‐occur with increasing levels of social inequality, human suffering, anxiety and sadness. The paper outlines the intersection between three key trajectories (economisation, spatialization and technologization) in order to demonstrate how particular assumptions about space, time, scale and subjectivity are implied in the framing of happiness as an objective scientific construct to be measured, and as a problem of government. These trajectories combine to create what I term a new spatial science of emotions, which is yet to be defined, empirically documented and critically analysed. It considers what kind of economic futures and contested knowledge practices are laid out by this new spatial science of emotions. By bringing together insights from critical economic geographies of neuroscientific and behavioural forms of governance, geographies of wellbeing, and social theories of embodied technologies, the paper challenges researchers to shift attention from subjective wellbeing to public wellbeing.
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Background Internet-based cognitive behavioural treatment (iCBT) has shown positive short-term effects on depression in patients with cardiovascular disease (CVD). However, knowledge regarding long-term effects and factors that may impact the effect of iCBT is lacking. Aims This study therefore sought (i) to evaluate the effect of iCBT on depression in CVD patients at 6- and 12-month follow-ups and (ii) to explore factors that might impact on the effect of iCBT on change in depression at 12-month follow-up. Methods and results A longitudinal follow-up study of a randomized controlled trial evaluating the effects of a 9-week iCBT programme compared to an online discussion forum (ODF) on depression in CVD patients (n = 144). After 9 weeks, those in the ODF group were offered the chance to take part in the iCBT programme. The Patient Health Questionnaire (PHQ-9) and the Montgomery–Åsberg Depression Rating Scale—self-rated version (MADRS-S) measured depression at baseline, 9 weeks, 6 months, and 12 months. Linear mixed model and multiple regression analysis were used for statistical computing. The iCBT programme significantly improved depression at 9-week follow-up and this was stable at 6- and 12-month follow-ups (PHQ-9 P = 0.001, MADRS-S P = 0.001). Higher levels of depression at baseline and a diagnosis of heart failure were factors found to impact the effect of iCBT on the change in depression. Conclusion A 9-week iCBT programme in CVD patients led to long-term improvement in depression. Higher levels of depression scores at baseline were associated with improvement in depression, whereas heart failure had opposite effect. Clinical trial The trial is registered at ClinicalTrials.gov, NCT02778074.
Article
Several studies have shown that, due to their features, mobile applications have a great potential to address mental health in depression and anxiety. We carried out a systematic review of publications from the last 10 years: from 1 January 2010 until 31 March 2020. Systematic reviews and meta-analyses related to the research question were also selected to identify other potentially eligible studies. The literature search in selected databases returned a total of 3,011 records from which a total of 22 articles were finally selected. The main conclusion of the study is that most of the scientific evidence found supports the hypothesis that mobile applications significantly improve the symptoms associated with depression and anxiety. Therefore, their effectiveness as a digital tool in the treatment of such health problems is proven. However, further studies and further evaluations of mobile applications are required (also in other languages) to incorporate this resource into the healthcare context. In addition, since mobile applications allow reinforcing concepts such as patient empowerment, shared decision-making and health literacy, their use would be highly positive for depression and anxiety, where there is a strong element of self-managing the disease.
Article
Over the last decade there has been an explosion of interest in mindfulness-based self-help (MBSH) interventions. While widely available and extensively promoted, there is little consensus on their impact in public health or healthcare contexts. We present a systematic review and meta-analyses of 83 randomized controlled trials, comparing unguided MBSH to control conditions on outcomes of depression, mindfulness, anxiety, stress and/or wellbeing/ quality of life. A random effects model was used to compute post-intervention, between-groups effect sizes for each outcome. MBSH demonstrated small, statistically significant effects at post-interventions for outcomes of depression (g = −0.23), mindfulness (g = 0.37) anxiety (g = −0.25), stress (g = −0.41) and wellbeing/ quality of life (g = 0.34). Significant effects were retained at follow-up for mindfulness, stress and wellbeing/ quality of life but not for depression or anxiety. Planned moderator analyses demonstrated significantly larger effects of MBSH when compared to inactive, versus active-control conditions on all outcomes except wellbeing/ quality of life, and non-digital MBSH interventions demonstrated significantly greater effects on depression, mindfulness and wellbeing/ quality of life outcomes than digitally-delivered MBSH. When studies that utilised samples selected for mental and physical health-related difficulties were respectively compared to studies that utilised unselected samples, no significant moderation effects were observed. In sum, these findings provide evidence for the effectiveness of unguided MBSH in public health settings and the practical, access-related implications of this are discussed.
Article
This paper connects findings from the field of placebo studies with research into patients’ interactions with their clinician’s visit notes, housed in their electronic health records. We propose specific hypotheses about how features of clinicians’ written notes might trigger mechanisms of placebo and nocebo effects to elicit positive or adverse health effects among patients. Bridging placebo studies with (a) survey data assaying patient and clinician experiences with portals and (b) randomized controlled trials provides preliminary support for our hypotheses. We conclude with actionable proposals for testing our understanding of the health effects of access to visit notes.
Article
We aimed to determine the effectiveness of online mindfulness-based interventions (MBIs) for improving mental health in patients with physical health conditions. Randomized controlled trials (RCTs) in PubMed, Cochrane Library, Web of Science, Elsevier, and CINAHL published through September 2019 were searched. Two reviewers selected trials, conducted a critical appraisal, and extracted the data. Meta-analyses were performed. A total of nine RCTs were included. Analyses revealed that online MBIs was effective in improving depression [standardized mean difference (SMD)=-0.22, 95% confidence interval (CI) (-0.37, -0.07), p =0.004], anxiety [SMD = -0.19, 95%CI (-0.33, -0.04), p =0.01], and stress [SMD =-0.32, 95% CI (-0.52, -0.13), p = 0.001], and mindfulness [SMD=1.67, 95% CI (0.14, 3.20), p =0.03] in patients with physical conditions. We did not find any obvious effects on well-being [SMD =1.12, 95%CI (-0.11, 2.36), p =0.08]. Nevertheless, additional well-designed randomized clinical trials are further needed.
Preprint
En matière de santé mentale, l'utilisation d'outils technologiques tels que des applications mobiles, des objets connectés ou encore des chatbots est en plein essor. Ce nombre croissant d'outils invite les cliniciens et chercheurs à une réflexion et une évolution des pratiques cliniques. Comment et pourquoi sont créés de tels outils ? Quel est le contenu ? À qui peuvent-ils être utiles ? Comment les utiliser ? À partir de notre expérience clinique et du retour des usagers, nous souhaitons partager notre cheminement et expérience de terrain relative à la création du chatbot de soutien psychologique Owlie co-créé avec les utilisateurs. Le chatbot est un outil perçu comme positif et soutenant dans le quotidien des personnes, qui les accompagne vers le rétablissement et s'utilise en complément d'un suivi avec un professionnel. Des travaux scientifiques continuent d'être effectués sur sa pertinence et son usage en pratique clinique. Abstract In the field of mental health, the use of technological tools such as mobile applications,
Article
Background There is certain evidence on the efficacy of smartphone-based mental health interventions. However, the mechanisms of action remain unclear. Placebo effects contribute to the efficacy of face-to-face mental health interventions and may also be a potential mechanism of action in smartphone-based interventions. Objective This study aimed to investigate whether different types of efficacy expectancies as potential factors underlying placebo effects could be successfully induced in a smartphone-based digital placebo mental health intervention, ostensibly targeting mood and stress. Methods We conducted a randomized, controlled, single-blinded, superiority trial with a multi-arm parallel design. Participants underwent an Android smartphone-based digital placebo mental health intervention for 20 days. We induced prospective efficacy expectancies via initial instructions on the purpose of the intervention and retrospective efficacy expectancies via feedback on the success of the intervention at days 1, 4, 7, 10, and 13. A total of 132 healthy participants were randomized to a prospective expectancy–only condition (n=33), a retrospective expectancy–only condition (n=33), a combined expectancy condition (n=34), or a control condition (n=32). As the endpoint, we assessed changes in efficacy expectancies with the Credibility Expectancy Questionnaire, before the intervention and on days 1, 7, 14, and 20. For statistical analyses, we used a random effects model for the intention-to-treat sample, with intervention day as time variable and condition as two factors: prospective expectancy (yes vs no) and retrospective expectancy (yes vs no), allowed to vary over participant and intervention day. Results Credibility (β=−1.63; 95% CI −2.37 to −0.89; P<.001) and expectancy (β=−0.77; 95% CI −1.49 to −0.05; P=.04) decreased across the intervention days. For credibility and expectancy, we found significant three-way interactions: intervention day×prospective expectancy×retrospective expectancy (credibility: β=2.05; 95% CI 0.60-3.50; P=.006; expectancy: β=1.55; 95% CI 0.14-2.95; P=.03), suggesting that efficacy expectancies decreased least in the combined expectancy condition and the control condition. Conclusions To our knowledge, this is the first empirical study investigating whether efficacy expectancies can be successfully induced in a specifically designed placebo smartphone-based mental health intervention. Our findings may pave the way to diminish or exploit digital placebo effects and help to improve the efficacy of digital mental health interventions. Trial Registration Clinicaltrials.gov NCT02365220; https://clinicaltrials.gov/ct2/show/NCT02365220.
Article
Background Chronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear. Objective The aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone. Methods Smartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week’s average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain–related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used. Results We screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI −0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app. Conclusions The study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques. Trial Registration ClinicalTrials.gov NCT02019134; https://clinicaltrials.gov/ct2/show/NCT02019134 International Registered Report Identifier (IRRID) RR2-10.1186/1745-6215-15-490
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Background: There is increasing interest in using mobile technologies such as smartphones for improving the care of patients with schizophrenia. However, less is known about the current clinical evidence for the feasibility and effectiveness of smartphone apps in this population. Objective: To review the published literature of smartphone apps applied for the care of patients with schizophrenia and other psychotic disorders. Methods: An electronic database search of Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, Health Technology Assessment Database, Allied and Complementary Medicine, Health and Psychosocial Instruments, PsycINFO, and Embase was conducted on May 24, 2015. All eligible studies were systematically reviewed, and proportional meta-analyses were applied to pooled data on recruitment, retention, and adherence to examine the overall feasibility of smartphone interventions for schizophrenia. Results: Our search produced 226 results from which 7 eligible articles were identified, reporting on 5 studies of smartphone apps for patients with schizophrenia. All examined feasibility, and one assessed the preliminary efficacy of a smartphone intervention for schizophrenia. Study lengths varied between 6 and 130 days. Overall retention was 92% (95% CI 82-98%). Participants consistently used the smartphone apps on more than 85% of days during the study period, averaging 3.95 interactions per person per day. Furthermore, participants responded to 71.9% of automated prompts (95% CI 65.7-77.8%). Participants reported a range of potential benefits from the various interventions, and user experience was largely positive. Conclusions: Although small, the current published literature demonstrates strong evidence for the feasibility of using smartphones to enhance the care of people with schizophrenia. High rates of engagement and satisfaction with a broad range of apps suggest the nascent potential of this mobile technology. However, there remains limited data on the efficacy of such interventions.
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Background: There is growing evidence for the positive impact of mindfulness on wellbeing. Mindfulness-based mobile apps may have potential as an alternative delivery medium for training. While there are hundreds of such apps, there is little information on their quality. Objective: This study aimed to conduct a systematic review of mindfulness-based iPhone mobile apps and to evaluate their quality using a recently-developed expert rating scale, the Mobile Application Rating Scale (MARS). It also aimed to describe features of selected high-quality mindfulness apps. Methods: A search for “mindfulness” was conducted in iTunes and Google Apps Marketplace. Apps that provided mindfulness training and education were included. Those containing only reminders, timers or guided meditation tracks were excluded. An expert rater reviewed and rated app quality using the MARS engagement, functionality, visual aesthetics, information quality and subjective quality subscales. A second rater provided MARS ratings on 30% of the apps for inter-rater reliability purposes. Results: The “mindfulness” search identified 700 apps. However, 94 were duplicates, 6 were not accessible and 40 were not in English. Of the remaining 560, 23 apps met inclusion criteria and were reviewed. The median MARS score was 3.2 (out of 5.0), which exceeded the minimum acceptable score (3.0). The Headspace app had the highest average score (4.0), followed by Smiling Mind (3.7), iMindfulness (3.5) and Mindfulness Daily (3.5). There was a high level of inter-rater reliability between the two MARS raters. Conclusions: Though many apps claim to be mindfulness-related, most were guided meditation apps, timers, or reminders. Very few had high ratings on the MARS subscales of visual aesthetics, engagement, functionality or information quality. Little evidence is available on the efficacy of the apps in developing mindfulness.
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Background: Smartphone applications for mental illnesses offer great potential, although the actual research base is still limited. Major depressive disorder and bipolar disorder are both common psychiatric illness for which smartphone application research has greatly expanded in the last two years. We review the literature on smartphone applications for major depressive and bipolar disoders in order to better understand the evidence base for their use, current research opportunities, and future clinical trends. Methods: We conducted an English language review of the literature, on November 1st 2014, for smartphone applications for major depressive and bipolar disorders. Inclusion criteria included studies featuring modern smartphones running native applications with outcome data related to major depressive or bipolar disorders. Studies were organized by use of active or passive data collection and focus on diagnostic or therapeutic interventions. Results: Our search identified 1065 studies. Ten studies on major depressive disorder and 4 on bipolar disorder were included. Nine out of 10 studies on depression related smartphone applications featured active data collection and all 4 studies on bipolar disorder featured passive data collection. Depression studies included both diagnostic and therapeutic smartphone applications, while bipolar disorder studies featured only diagnostics. No studies addressed physiological data. Conclusions: While the research base for smartphone applications is limited, it is still informative. Numerous opportunities for further research exist, especially in the use of passive data for, major depressive disorder, validating passive data to detect mania in bipolar disorder, and exploring the use of physiological data. As interest in smartphones for psychiatry and mental health continues to expand, it is important that the research base expands to fill these gaps and provide clinically useful results.
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With increasing numbers of people with Alzheimer's and other dementias across the globe, many countries have developed national plans to deal with the resulting challenges. In the United States, the National Alzheimer's Project Act, signed into law in 2011, required the creation of such a plan with annual updates thereafter. Pursuant to this, the US Department of Health and Human Services (HHS) released the National Plan to Address Alzheimer's Disease in 2012, including an ambitious research goal of preventing and effectively treating Alzheimer's disease by 2025. To guide investments, activities, and the measurement of progress toward achieving this 2025 goal, in its first annual plan update (2013) HHS also incorporated into the plan a set of short, medium and long-term milestones. HHS further committed to updating these milestones on an ongoing basis to account for progress and setbacks, and emerging opportunities and obstacles. To assist HHS as it updates these milestones, the Alzheimer's Association convened a National Plan Milestone Workgroup consisting of scientific experts representing all areas of Alzheimer's and dementia research. The workgroup evaluated each milestone and made recommendations to ensure that they collectively constitute an adequate work plan for reaching the goal of preventing and effectively treating Alzheimer's by 2025. This report presents these Workgroup recommendations.
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Background: Currently, there are over 400 smoking cessation smartphone apps available, downloaded an estimated 780,000 times per month. No prior studies have examined how individuals engage with specific features of cessation apps and whether use of these features is associated with quitting. Objectives: Using data from a pilot trial of a novel smoking cessation app, we examined: (i) the 10 most-used app features, and (ii) prospective associations between feature usage and quitting. Methods: Participants (n = 76) were from the experimental arm of a randomized, controlled pilot trial of an app for smoking cessation called "SmartQuit," which includes elements of both Acceptance and Commitment Therapy (ACT) and traditional cognitive behavioral therapy (CBT). Utilization data were automatically tracked during the 8-week treatment phase. Thirty-day point prevalence smoking abstinence was assessed at 60-day follow-up. Results: The most-used features - quit plan, tracking, progress, and sharing - were mostly CBT. Only two of the 10 most-used features were prospectively associated with quitting: viewing the quit plan (p = 0.03) and tracking practice of letting urges pass (p = 0.03). Tracking ACT skill practice was used by fewer participants (n = 43) but was associated with cessation (p = 0.01). Conclusions: In this exploratory analysis without control for multiple comparisons, viewing a quit plan (CBT) as well as tracking practice of letting urges pass (ACT) were both appealing to app users and associated with successful quitting. Aside from these features, there was little overlap between a feature's popularity and its prospective association with quitting. Tests of causal associations between feature usage and smoking cessation are now needed.
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Importance Patients leaving residential treatment for alcohol use disorders are not typically offered evidence-based continuing care, although research suggests that continuing care is associated with better outcomes. A smartphone-based application could provide effective continuing care.Objective To determine whether patients leaving residential treatment for alcohol use disorders with a smartphone application to support recovery have fewer risky drinking days than control patients.Design, Setting, and Participants An unmasked randomized clinical trial involving 3 residential programs operated by 1 nonprofit treatment organization in the Midwestern United States and 2 residential programs operated by 1 nonprofit organization in the Northeastern United States. In total, 349 patients who met the criteria for DSM-IV alcohol dependence when they entered residential treatment were randomized to treatment as usual (n = 179) or treatment as usual plus a smartphone (n = 170) with the Addiction–Comprehensive Health Enhancement Support System (A-CHESS), an application designed to improve continuing care for alcohol use disorders.Interventions Treatment as usual varied across programs; none offered patients coordinated continuing care after discharge. A-CHESS provides monitoring, information, communication, and support services to patients, including ways for patients and counselors to stay in contact. The intervention and follow-up period lasted 8 and 4 months, respectively.Main Outcomes and Measures Risky drinking days—the number of days during which a patient’s drinking in a 2-hour period exceeded 4 standard drinks for men and 3 standard drinks for women, with standard drink defined as one that contains roughly 14 g of pure alcohol (12 oz of regular beer, 5 oz of wine, or 1.5 oz of distilled spirits). Patients were asked to report their risky drinking days in the previous 30 days on surveys taken 4, 8, and 12 months after discharge from residential treatment.Results For the 8 months of the intervention and 4 months of follow-up, patients in the A-CHESS group reported significantly fewer risky drinking days than did patients in the control group, with a mean of 1.39 vs 2.75 days (mean difference, 1.37; 95% CI, 0.46-2.27; P = .003).Conclusions and Relevance The findings suggest that a multifeatured smartphone application may have significant benefit to patients in continuing care for alcohol use disorders.Trial Registration clinicaltrials.gov Identifier: NCT01003119
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Psychiatry residencies with a commitment to humanism commonly prioritize training in psychotherapy, cultural psychiatry, mental health policy, promotion of human rights, and similar areas reliant upon dialogue and collaborative therapeutic relationships. The advent of neuroscience as a defining paradigm for psychiatry has challenged residencies with a humanistic focus due to common perceptions that it would entail constriction of psychiatric practice to diagnostic and psychopharmacology roles. The author describes a neuroscience curriculum that has taught psychopharmacology effectively, while also advancing effectiveness of language-based and relationship-based therapeutics. In 2000, the George Washington University psychiatry residency initiated a neuroscience curriculum consisting of (1) a foundational postgraduate year 2 seminar teaching cognitive and social neuroscience and its integration into clinical psychopharmacology, (2) advanced seminars that utilized a neuroscience perspective in teaching specific psychotherapeutic skill sets, and (3) case-based teaching in outpatient clinical supervisions that incorporated a neuroscience perspective into traditional psychotherapy supervisions. Curricular assessment was conducted by (1) RRC reaccreditation site visit feedback, (2) examining career trajectories of residency graduates, (3) comparing PRITE exam Somatic Treatments subscale scores for 2010-2012 residents with pre-implementation residents, and (4) postresidency survey assessment by 2010-2012 graduates. The 2011 RRC site visit report recommended a "notable practice" citation for "innovative neurosciences curriculum." Three of twenty 2010-2012 graduates entered neuroscience research fellowships, as compared to none before the new curriculum. PRITE Somatic Treatments subscale scores improved from the 23rd percentile to the 62nd percentile in pre- to post-implementation of curriculum (p < .001). Recent graduates rated effectiveness of clinical psychopharmacology training as 8.6 on ten-point Likert scale. From multiple vantage points of assessment, these outcome results support effectiveness of this neuroscience curriculum for a residency committed to humanistic psychiatry as its primary mission. As a naturalistic study, further examination of its methods in pretest and posttest assessments and a multisite comparison is warranted.
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Background Current diagnostic systems for mental disorders rely upon presenting signs and symptoms, with the result that current definitions do not adequately reflect relevant neurobiological and behavioral systems - impeding not only research on etiology and pathophysiology but also the development of new treatments. Discussion The National Institute of Mental Health began the Research Domain Criteria (RDoC) project in 2009 to develop a research classification system for mental disorders based upon dimensions of neurobiology and observable behavior. RDoC supports research to explicate fundamental biobehavioral dimensions that cut across current heterogeneous disorder categories. We summarize the rationale, status and long-term goals of RDoC, outline challenges in developing a research classification system (such as construct validity and a suitable process for updating the framework) and discuss seven distinct differences in conception and emphasis from current psychiatric nosologies. Summary Future diagnostic systems cannot reflect ongoing advances in genetics, neuroscience and cognitive science until a literature organized around these disciplines is available to inform the revision efforts. The goal of the RDoC project is to provide a framework for research to transform the approach to the nosology of mental disorders.
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Background With a lifetime risk for major depressive disorder of up to 50%, depression is a common comorbidity in multiple sclerosis but remains widely underdiagnosed and untreated. We investigated the potential of a fully automated, internet-based, cognitive behavioural therapy programme, Deprexis, to reduce depressive symptoms in patients with multiple sclerosis. Methods For this randomised controlled trial, we recruited patients from an outpatient clinic in Hamburg, Germany. Patients aged 18–65 years were eligible for inclusion if they had multiple sclerosis and self-reported depressive symptoms. By use of a computer-generated randomisation sequence, we allocated 90 patients (1:1; no blocking or stratification) to either the intervention group or a waitlist control group for 9 weeks. The primary endpoint was the Beck Depression Inventory (BDI), as assessed by an intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT01663649. Findings 71 patients completed the trial: 35 patients in the intervention group and 36 patients in the control group. During the intervention, BDI scores decreased in the Deprexis group and increased in the control group, yielding a positive effect of Deprexis relative to the waitlist group (mean group difference −4·02 points [95% CI −7·26 to −0·79], p=0·015, effect size d=0·53). Worsening of depressive symptoms from below to above the clinical cutoff (BDI >13) occurred in three (7%) of 45 patients in the control group and no patients in the Deprexis group. We noted no adverse events with respect to new occurrence of suicidal ideation during the trial. Interpretation Psychological online-intervention programmes could be suitable for patients with multiple sclerosis who are unable to regularly attend therapeutic sessions because of mobility impairments. Funding European Union and the Deutsche Forschungsgemeinschaft.
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This study uniquely examined the impacts on self, cognition, anxiety, and physiology when iPhone users are unable to answer their iPhone while performing cognitive tasks. A 2 x 2 within-subjects experiment was conducted. Participants (N = 40 iPhone users) completed two word search puzzles. Among the key findings from this study were that when iPhone users were unable to answer their ringing iPhone during a word search puzzle, heart rate and blood pressure increased, self-reported feelings of anxiety and unpleasantness increased, and self-reported extended self and cognition decreased. These findings suggest that negative psychological and physiological outcomes are associated with iPhone separation and the inability to answer one’s ringing iPhone during cognitive tasks. Implications of findings are discussed.
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Context: Pathology residency training programs should aim to teach residents to think beyond the compartmentalized data of specific rotations and synthesize data in order to understand the whole clinical picture when interacting with clinicians. Objective: To test a collaborative autopsy procedure at Montefiore Medical Center (Bronx, New York), linking residents and attending physicians from anatomic and clinical pathology in the autopsy process from the initial chart review to the final report. Residents consult with clinical pathology colleagues regarding key clinical laboratory findings during the autopsy. This new procedure serves multiple functions: creating a team-based, mutually beneficial educational experience; actively teaching consultative skills; and facilitating more in-depth analysis of the clinical laboratory findings in autopsies. Design: An initial trial of the team-based autopsy system was done from November 2010 to December 2012. Residents were then surveyed via questionnaire to evaluate the frequency and perceived usefulness of clinical pathology autopsy consultations. Results: Senior residents were the most frequent users of clinical pathology autopsy consultation. The most frequently consulted services were microbiology and chemistry. Eighty-nine percent of the residents found the clinical pathology consultation to be useful in arriving at a final diagnosis and clinicopathologic correlation. Conclusion: The team-based autopsy is a novel approach to integration of anatomic and clinical pathology curricula at the rotation level. Residents using this approach develop a more holistic approach to pathology, better preparing them for meaningful consultative interaction with clinicians. This paradigm shift in training positions us to better serve in our increasing role as arbiters of outcomes measures in accountable care organizations.
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Clinical and neurobiological data suggest that psychiatric disorders, as traditionally defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), are (1) more comorbid than expected by chance, (2) often share neurobiological signatures, and (3) reflect alterations across multiple brain systems that mediate particular mental processes. As such, emerging conceptualizations such at the National Institute of Mental Health's Research Domain Criteria Project (RDoC) have suggested that a different way to understand psychopathology may be with respect to the degree of dysfunction in each of these brain systems, seen dimensionally, which both cross traditional diagnostic boundaries and extend to a healthy range of functioning. At present, however, this scientific perspective has not been incorporated into neuroscience education in psychiatry, nor has its relationship to clinical care been made clear. We describe the rationale and implementation of a reformulated neuroscience course given to psychiatric residents at Stanford University centered on the conceptual framework of RDoC. Data are presented on resident feedback before and after revision of the course. A clear motivation and rationale exists for teaching neuroscience in a transdiagnostic framework. This course was taken up well by the residents, with overall feedback significantly more positive than that prior to the course revision. This "proof of concept" neuroscience course illustrates a potential route for bridging between rapid advances in psychiatric neuroscience and the clinical education for trainees not otherwise versed in neuroscience but who are needed for scientific advances to translate to the clinic. The promise of this approach may be in part related to the similarity between this framework and problem-based approaches common in routine clinical care. In such approaches, clinicians focus on the expressed complaints of their individual patient and identify specific symptoms as the target of treatment-symptoms which are presumably the expression of dysfunction in specific brain systems.
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The stepped-care approach, where people with early symptoms of depression are stepped up from low-intensity interventions to higher-level interventions as needed, has the potential to assist many people with mild depressive symptoms. Self-monitoring techniques assist people to understand their mental health symptoms by increasing their emotional self-awareness (ESA) and can be easily distributed on mobile phones at low cost. Increasing ESA is an important first step in psychotherapy and has the potential to intervene before mild depressive symptoms progress to major depressive disorder. In this secondary analysis we examined a mobile phone self-monitoring tool used by young people experiencing mild or more depressive symptoms to investigate the relationships between self-monitoring, ESA, and depression. We tested two main hypotheses: (1) people who monitored their mood, stress, and coping strategies would have increased ESA from pretest to 6-week follow-up compared with an attention comparison group, and (2) an increase in ESA would predict a decrease in depressive symptoms. We recruited patients aged 14 to 24 years from rural and metropolitan general practices. Eligible participants were identified as having mild or more mental health concerns by their general practitioner. Participants were randomly assigned to either the intervention group (where mood, stress, and daily activities were monitored) or the attention comparison group (where only daily activities were monitored), and both groups self-monitored for 2 to 4 weeks. Randomization was carried out electronically via random seed generation, by an in-house computer programmer; therefore, general practitioners, participants, and researchers were blinded to group allocation at randomization. Participants completed pretest, posttest, and 6-week follow-up measures of the Depression Anxiety Stress Scale and the ESA Scale. We estimated a parallel process latent growth curve model (LGCM) using Mplus to test the indirect effect of the intervention on depressive symptoms via the mediator ESA, and calculated 95% bias-corrected bootstrapping confidence intervals (CIs). Of the 163 participants assessed for eligibility, 118 were randomly assigned and 114 were included in analyses (68 in the intervention group and 46 in the comparison group). A parallel process LGCM estimated the indirect effect of the intervention on depressive symptoms via ESA and was shown to be statistically significant based on the 95% bias-corrected bootstrapping CIs not containing zero (-6.366 to -0.029). The proportion of the maximum possible indirect effect estimated was κ(2 )=.54 (95% CI .426-.640). This study supported the hypothesis that self-monitoring increases ESA, which in turn decreases depressive symptoms for young people with mild or more depressive symptoms. Mobile phone self-monitoring programs are ideally suited to first-step intervention programs for depression in the stepped-care approach, particularly when ESA is targeted as a mediating factor. ClinicalTrials.gov NCT00794222; http://clinicaltrials.gov/ct2/show/NCT00794222 (Archived by WebCite at http://www.webcitation.org/65lldW34k).
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Pathology as a basic science discipline traditionally is a component of the preclinical medical school curriculum. While there have been regional and nationwide surveys reporting on the curricular organization and instructional formats of preclinical pathology instruction, the extent of required pathology integration into the clinical medical school curriculum, particularly as it relates to practical issues of patient management, has not been studied. A survey soliciting information about required pathology programs in the clinical years was distributed to the members of the Undergraduate Medical Educators Section of the Association of Pathology Chairs (APC). A literature search of such programs was also performed. Thirty-seven respondents representing 30 medical schools (21% of the 140 Liaison Committee on Medical Education-accredited medical schools in the APC) described a total of 16 required pathology programs in the clinical years. An additional 10 programs were identified in the literature. Advantages of required pathology activities in the clinical years include educating medical students in effective utilization of anatomic and clinical pathology for patient care and exposing them to the practice of pathology. Reported challenges have been competition for curricular time in the clinical years, attitudinal resistance by clerkship directors, failure to recognize pathology as a clinical discipline, and insufficient number of faculty in pathology departments. By survey sample and literature review, there has been relatively little progress in the integration of required pathology exposure into the clinical years. Development of practice-related pathology competencies may facilitate introduction of such curricular programs in the future.
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Consecutive new neurology inpatients and outpatients (N=198) were assessed for somatoform disorders by using the Schedules for Clinical Assessment in Neuropsychiatry. Sixty-one percent of the patients (59% of the female patients and 63% of the male patients) had at least one medically unexplained symptom, and 34.9% fulfilled the diagnostic criteria for an ICD-10 somatoform disorder (27.7% of the male patients, 41.3% of the female patients, 20.5% of the inpatients, and 43.2% of the outpatients). The prevalence figures were about the same when DSM-IV criteria for somatoform disorders were used. Of the patients with a somatoform disorder, 60.5% also had another mental disorder. Somatization disorder, somatoform autonomic dysfunction, pain disorder, and neurasthenia were equally prevalent (6%-7%); dissociative (conversion) disorders and undifferentiated somatoform disorders were found in 2-3% of the patients. Fifty percent of the patients with somatoform disorders were identified by the neurologists.
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Progress in understanding the placebo effect and its clinical significance depends on conceptual clarification of this elusive phenomenon and critical appraisal of research bearing on the influence of placebo interventions on clinical outcomes. Here we locate the placebo effect within a typology of modes of healing, distinguish between the observed placebo response in randomized controlled trials and the placebo effect, and examine critically a recent meta-analysis of clinical trials that challenges the reality of the placebo effect.
Mobile technology fact sheet. http://www. pewinternet.org/fact-sheets/mobile-technology-fact-sheet
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Smartphone apps for schizophrenia: a systematic review: e102. 3 IMS Institute Reports. Patient adoption of mHealth
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