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The digital placebo effect: Mobile mental health meets clinical psychiatry
... As an advantage, mCBT might be initiated shortly after symptom onset or exacerbation. Notably, preliminary evidence shows that mCBT might promote higher adherence rates than iCBT (70), which could be related to its unique futures (e.g., push notifications)(71) and a so-called "digital placebo effect" (72). Interestingly, mindfulness-based interventions share characteristics with traditional forms of CBT and have shown benefit in various neuropsychiatric disorders, including in improving quality of life in seizure forms of FND (73)(74)(75)(76)(77). Brief trainings in focused attention and breathing forms of mindfulness may improve memory performance (75,78), build self-compassion, and cognitive flexibility (79), with possible brain network change in areas involved in attentional and emotional processes (80,81), which are likely relevant in FCD. ...
... The availability of a treatment option may also help legitimise their condition near their friends, family and employers. The ability to self-monitor their condition and a sense of hope and social support via a digital tool may also further promote the placebo effect, inherent to any intervention, and already demonstrated in FCD (72,96). ...
Background:
Functional cognitive disorder (FCD) is a common and disabling condition for which accessible and evidence-based treatments are urgently needed.
Objective:
We describe the planning and development stages of a new self-help mobile app intervention for FCD.
Methods:
The UK Medical Research Council's Complex Interventions framework was followed. Theory- and user-centered approaches were adopted to develop Mementum – a 6-week programme rooted on cognitive behavioural techniques and complementary principles (mindfulness, education, cognitive rehabilitation).
Results:
A scoping review is presented. Thematic analysis of patient interviews identified 6 themes and 13 subthemes, including user needs, management strategies, opportunity and motivation. The treatment model places attentional dysregulation as the core symptom generator, around which treatment content was developed. Provisional insights from a focus group suggested the intervention is acceptable and credible. Facilitators and barriers were uncovered and addressed. The programme includes 7 modules, videos, patient stories, FAQs, and signposting to existing resources. Interactive features include a weekly memory diary and symptom checklist, tailoring of contents to symptoms, and homework tasks.
Conclusions:
We used a systematic approach to develop a novel digital health intervention for FCD. Collaborations with key stakeholders enabled intervention development and optimisation. Feasibility, acceptability, and efficacy testing of this intervention are underway.
... Previous research highlights the importance and challenges of creating robust control conditions to account for improvements unrelated to digital interventions [22,23]. Accordingly, we designed the control condition to address improvements influenced by participants' implicit goal to improve their emotional states, which can trigger emotion regulation by itself (emotion goals [24]), participants' potential motivation to align with the experiment's objectives (demand characteristics [25]), and participants' expectations for the digital intervention to be effective (digital placebo effect [23]). ...
... When contrasting the effectiveness of InsightApp with these interventions, it is important to take into account factors such as the intervention duration, experimental design, the inclusion of control conditions, and the strength of those control conditions. As discussed in the Methods section, previous work has emphasized the significance and complexities involved in crafting robust control conditions that can effectively address the digital placebo effect [22,23]. This phenomenon involves improvements in outcome variables that are driven by their belief in the effectiveness of the digital intervention. ...
Background
Anxiety disorders are among the most prevalent mental disorders, and stress plays a significant role in their development. Ecological momentary interventions (EMIs) hold great potential to help people manage stress and anxiety by training emotion regulation and coping skills in real-life settings. InsightApp is a gamified EMI and research tool that incorporates elements from evidence-based therapeutic approaches. It is designed to strengthen people’s metacognitive skills for coping with challenging real-life situations and embracing anxiety and other emotions.
Objective
This randomized controlled trial aims to examine the effectiveness of InsightApp in (1) improving individuals’ metacognitive strategies for coping with stress and anxiety and (2) promoting value-congruent action. It also evaluates how long these effects are retained. This experiment advances our understanding of the role of metacognition in emotional and behavioral reactivity to stress.
Methods
We conducted a randomized controlled trial with 228 participants (completion rate: n=197, 86.4%; mean age 38, SD 11.50 years; age range 20-80 years; female: n=101, 52.6%; and White: n=175, 91.1%), who were randomly assigned to either the treatment or the active placebo control group. During the 1-week intervention phase, the treatment group engaged with InsightApp, while participants in the control group interacted with a placebo version of the app that delivered executive function training. We assessed the differences between the 2 groups in posttest and follow-up assessments of mental health and well-being while controlling for preexisting differences. Moreover, we used a multilevel model to analyze the longitudinal data, focusing on the within-participant causal effects of the intervention on emotional and behavioral reactivity to daily stressors. Specifically, we measured daily anxiety, struggle with anxiety, and value-congruent action.
Results
The intervention delivered by InsightApp yielded mixed results. On one hand, we found no significant posttest scores on mental health and well-being measures directly after the intervention or 7 days later (all P>.22). In contrast, when confronted with real-life stress, the treatment group experienced a 15% lower increase in anxiety (1-tailed t test, t197=–2.4; P=.009) and a 12% lower increase in the struggle with anxiety (t197=–1.87; P=.031) than the control group. Furthermore, individuals in the treatment group demonstrated a 7% higher tendency to align their actions with their values compared to the control group (t197=3.23; P=.002). After the intervention period, InsightApp’s positive effects on the struggle with anxiety in reaction to stress were sustained, and increased to an 18% lower reactivity to stress (t197=–2.84; P=.002).
Conclusions
As our study yielded mixed results, further studies are needed to obtain an accurate and reliable understanding of the effectiveness of InsightApp. Overall, our findings tentatively suggest that guiding people to apply adaptive metacognitive strategies for coping with real-life stress daily with a gamified EMI is a promising approach that deserves further evaluation.
Trial Registration
OSF Registries osf.io/k3b5d; https://osf.io/k3b5d
... Sixth, it is important to acknowledge the possibility of a digital placebo effect [111]. In an unblinded trial, participants might attribute their improvements to the mere use of an mHealth intervention rather than its specific components. ...
... Expectations and engagement could introduce positive bias into the outcomes. Future research should carefully plan control conditions, which might include active control groups or sham interventions [111]. ...
Background:
Globally, students face increasing mental health challenges, including elevated stress levels and declining well-being, leading to academic performance issues and mental health disorders. However, due to stigma and symptom underestimation, students rarely seek effective stress management solutions. Conversational agents in the health sector have shown promise in reducing stress, depression, and anxiety. Nevertheless, research on their effectiveness for students with stress remains limited.
Objective:
This study aims to develop a conversational agent–delivered stress management coaching intervention for students called MISHA and to evaluate its effectiveness, engagement, and acceptance.
Methods:
In an unblinded randomized controlled trial, Swiss students experiencing stress were recruited on the web. Using a 1:1 randomization ratio, participants (N=140) were allocated to either the intervention or waitlist control group. Treatment effectiveness on changes in the primary outcome, that is, perceived stress, and secondary outcomes, including depression, anxiety, psychosomatic symptoms, and active coping, were self-assessed and evaluated using ANOVA for repeated measure and general estimating equations.
Results:
The per-protocol analysis revealed evidence for improvement of stress, depression, and somatic symptoms with medium effect sizes (Cohen d=−0.36 to Cohen d=−0.60), while anxiety and active coping did not change (Cohen d=−0.29 and Cohen d=0.13). In the intention-to-treat analysis, similar results were found, indicating reduced stress (β estimate=−0.13, 95% CI −0.20 to −0.05; P<.001), depressive symptoms (β estimate=−0.23, 95% CI −0.38 to −0.08; P=.003), and psychosomatic symptoms (β estimate=−0.16, 95% CI −0.27 to −0.06; P=.003), while anxiety and active coping did not change. Overall, 60% (42/70) of the participants in the intervention group completed the coaching by completing the postintervention survey. They particularly appreciated the quality, quantity, credibility, and visual representation of information. While individual customization was rated the lowest, the target group fitting was perceived as high.
Conclusions:
Findings indicate that MISHA is feasible, acceptable, and effective in reducing perceived stress among students in Switzerland. Future research is needed with different populations, for example, in students with high stress levels or compared to active controls.
Trial Registration:
German Clinical Trials Register DRKS 00030004; https://drks.de/search/en/trial/DRKS00030004
... This feedback, combined with the improved outcome scores, suggests that participants made important gains regardless of potential expectancy bias. Relatedly, having an active control group would help determine specific effects of the intervention as opposed to the possibility of "digital placebo" (Torous & Firth, 2016) and would likely show smaller intervention effect sizes since larger intervention effect sizes tend to be found when compared to an inactive versus an active control group (Linardon, 2020). ...
Objectives
In-person mindfulness-based interventions (MBIs) have been shown to decrease symptoms of anxiety and stress in autistic adults, who often report high levels of these symptoms. Little is known about the effectiveness of remote MBIs for this population, which may be particularly useful given the common barriers autistic adults face in accessing in-person treatment. This study examined the feasibility and effectiveness of an app-based mindfulness intervention for autistic adults.
Method
This randomized controlled trial (RCT) examined whether a 6-week remote intervention, using a customized version of the Healthy Minds Program app, reduced symptoms of anxiety and perceived stress in 89 autistic adults. Participants were randomly assigned to either the mindfulness intervention or a wait-list control (WLC) group. The WLC group received the intervention after the RCT. Self-report measures of anxiety, perceived stress, positive and negative affect, and trait mindfulness were administered at several timepoints.
Results
The mindfulness group showed significant decreases in anxiety symptoms and perceived stress relative to the control group, with medium to large between-groups effect sizes (ηp² 0.07 to 0.14). These benefits, as well as significant decreases in negative affect and increases in trait mindfulness, were replicated when the WLC group subsequently received the intervention, and were retained in both groups 6 weeks after conclusion of the intervention.
Conclusions
Results demonstrate both the feasibility and effectiveness of a remote mindfulness self-guided intervention for reducing perceived stress and anxiety symptoms in autistic adults. Future research can investigate the specific processes of how such an intervention exerts its effects.
Preregistration
ClinicalTrials.gov TRN: NCT05880498, 5/30/23, retrospectively registered.
... While VR devices are becoming increasingly available, they remain a substantial investment that may not be feasible for all healthcare providers or individuals, particularly in resource-limited settings. This could potentially exacerbate existing health disparities if VR-enhanced interventions become standard care without consideration for equitable access 82 . Future research should explore cost-effective alternatives or strategies for implementing VRenhanced interventions in diverse healthcare settings, particularly focusing on populations with high risk for comorbid postpartum depression and anxiety. ...
The postpartum period has witnessed increasing rates of depression and anxiety, particularly in the context of the COVID-19 pandemic, with these conditions often co-occurring and being exacerbated by the lingering effects of long COVID. Traditional interventions, such as mindfulness-based stress reduction (MBSR) and yoga, have demonstrated effectiveness in alleviating these symptoms. However, the limitations of in-person sessions, especially in the context of pandemic-related restrictions, highlight the need for accessible, innovative approaches. Integrating Virtual Reality (VR) technology with these traditional practices presents a novel solution, offering immersive, customizable environments that may enhance engagement and therapeutic outcomes. This study evaluates the effectiveness of a VR-enhanced mindfulness and yoga intervention in treating postpartum depression and anxiety in women affected by long COVID, with additional examination of underlying physiological stress markers and cognitive control mechanisms. In this randomized controlled trial, 111 postpartum women were randomly assigned to experimental (VR-enhanced intervention), control (traditional in-person sessions), or blank groups using computer-generated randomization. The 8-week intervention involved thrice-weekly 60-minute sessions. Outcomes were assessed at baseline, post-intervention, and 4-week follow-up using the Edinburgh Postnatal Depression Scale (EPDS), Generalized Anxiety Disorder-7 (GAD-7) scale, salivary cortisol measurements, and an emotional Stroop task. The VR-enhanced intervention group demonstrated significant improvements in both depression (EPDS: P < 0.001, ηp² = 0.18) and anxiety symptoms (GAD-7: P < 0.001, ηp² = 0.17), with these therapeutic effects significantly greater than those observed in the control and blank groups (P < 0.001 for both comparisons). These improvements were strongly correlated (r = 0.68, P < 0.001). Supporting these primary outcomes, salivary cortisol levels showed a significant decrease (P < 0.001, ηp² = 0.13), and cognitive control improved as evidenced by reduced emotional Stroop task conflict effect (P < 0.001, ηp² = 0.37). Correlation analysis revealed robust associations between improvements in depression and anxiety symptoms and changes in physiological markers in both short-term and long-term outcomes. This study demonstrates that integrating VR technology with traditional mindfulness and yoga practices effectively reduces both postpartum depression and anxiety symptoms in the post-COVID era. The parallel improvements in physiological stress markers and cognitive control provide insight into potential mechanisms underlying these therapeutic effects. These findings underscore the value of immersive technology in enhancing traditional therapeutic approaches for addressing postpartum depression and anxiety in the post-pandemic context.
... With these two arms of the clinical study differing from each other only in the presence or absence of personalized feedback, we can conclude that personalized feedback is effective. Thus, the digital placebo effect (defined as the therapeutic effect resulting from the simple use of the smartphone without any real effect of the mobile application) will be limited (Torous and Firth 2016b). ...
Objective
The purpose of this paper is to describe a study protocol of a clinical trial exploring the effectiveness of the new mobile application MyDéfi proposing personalized feedback, on both alcohol consumption and quality of life, as well as the blood alcohol exposure biomarker phosphatidylethanol, in university students displaying binge drinking behavior.
Methods
This prospective national multicentric randomized, two‐arm (1:1), double‐blind controlled trial will recruit 628 students (aged 18–25 years) with binge drinking behavior. Participants will be randomized in the “intervention” group (personalized feedback) or the “control” group (generic feedback) and will undergo four monthly visits. Monthly dried blood spot sample for measuring phosphatidylethanol concentration and online questionnaires will be collected. Our primary objective is to assess the reduction weekly standard drinks, through self‐report gathered via MyDéfi. Secondary objectives will evaluate the application's impact on the dosage of phosphatidylethanol blood concentration and on quality of life”.
Results
Recruitment started in March 2024 and will end in March 2026.
Conclusion
This study aims to determine the effectiveness of two versions of the same mobile application (generic vs. personalized feedback) on alcohol consumption in students displaying binge drinking behavior. The effectiveness of the application will be measured, with a secondary objective of quantifying phosphatidylethanol. Our study will open new perspectives on the use of digital interventions for students who do not actively seek treatment.
Trial Registration
Trial registration number (NCT06084832), the date of registration (10th October 2023) and when this was done (16th October 2023). https://clinicaltrials.gov/study/NCT06084832
... As shown in Figure 3, during the 7-day intervention, participants initially increased their activity in the first few days but showed a gradual decline. This may suggest that the initial increase in physical activity was driven by the novelty of interacting with an AI chatbot, and the similarity in improvement between groups suggests a potential digital placebo effect linked to user expectations of digital devices, 60 where the mere act of interacting with any chatbot, regardless of its relational capabilities, may have motivated increased activity. ...
Objective
This study presents a pilot randomized controlled trial to assess the usability, feasibility, and initial efficacy of a mobile app-based relational artificial intelligence (AI) chatbot (Exerbot) intervention for increasing physical activity behavior.
Methods
The study was conducted over a 1-week period, during which participants were randomized to either converse with a baseline chatbot without relational capacity (control group) or a relational chatbot using social relational communication strategies. Objectively measured physical activity data were collected using smartphone pedometers.
Results
The study was feasible in enrolling a sample of 36 participants and with a 94% retention rate after 1 week. Daily engagement rate with the AI chatbot reached over 88% across the groups. Findings revealed that the control group experienced a significant decrease in steps on the final day, whereas the group interacting with the relational chatbot maintained their step counts throughout the study period. Importantly, individuals who engaged with the relational chatbot reported a stronger social bond with the chatbot compared to those in the control group.
Conclusions
Leveraging AI chatbot and the relationship-building capabilities of AI holds promise in the development of cost-effective, accessible, and sustainable behavior change interventions. This approach may benefit individuals with limited access to conventional in-person behavior interventions.
Clinical trial registrations
ClinicalTrials.gov; NCT05794308; https://clinicaltrials.gov/ct2/show/NCT05794308.
... A recent study provides evidence of a temporary digital placebo effect in smartphone-based mental health interventions [92]. The digital placebo occurs when users experience benefits from digital technologies due to their beliefs in the tools rather than from their actual functionalities [93]. Initial expectancy and credibility of digital tools can taper off and potentially lead to reduced effectiveness in outcomes [92]. ...
Background
Corporate wellness programs are increasingly using digital technologies to promote employee health. Digital wellness programs (DWPs) refer to initiatives that deliver health interventions through digital tools. Despite a growing body of evidence on DWPs, the literature remains fragmented across multiple health domains.
Objective
This study aims to provide a comprehensive synthesis of existing research on the efficacy (eg, impact on employee’s physical health, mental well-being, behavioral changes, and absenteeism) and acceptability (eg, engagement, perceived usefulness, and adoption) of employer-provided DWPs. Specifically, we aim to map the extent, range, and nature of research on this topic; summarize key findings; identify gaps; and facilitate knowledge dissemination.
Methods
We conducted a meta-review of studies published between 2000 and 2023. We adopted a database-driven search approach, including the MEDLINE, PsycINFO, ProQuest Central, and Web of Science Core Collection databases. The inclusion criteria consisted of (1) review articles; (2) publications in English, French, or German; (3) studies reporting on digital health interventions implemented in organizations; (4) studies reporting on nonclinical or preclinical employee populations; and (5) studies assessing the efficacy and acceptability of employer-provided DWPs. We performed a descriptive numerical summary and thematic analysis of the included studies.
Results
Out of 593 nonduplicate studies screened, 29 met the inclusion criteria. The most investigated health domains included mental health (n=19), physical activity (n=8), weight management (n=6), unhealthy behavior change (n=4), and sleep management (n=2). In total, 24 reviews focused on the efficacy of DWPs, primarily in relation to health-related outcomes (eg, stress and weight), while fewer reviews addressed organization-related outcomes (eg, burnout and absenteeism). Four reviews explored the mechanisms of action, and 3 assessed the acceptability of DWPs using various measures. Overall, the findings support the efficacy and acceptability of DWPs, although significant gaps persist, particularly regarding the durability of outcomes, the role of technology, and the causal mechanisms underlying behavioral change.
Conclusions
While DWPs show promise across a variety of health domains, several aspects of their effectiveness remain underexplored. Practitioners should capitalize on existing evidence of successful DWPs while acknowledging the limitations in the literature.
... Younge et al. (2020) developed a reinforcement algorithm that dynamically adjusts the intensity of internet-based CBT engagement, potentially improving treatment adherence and outcomes. While these applications show promise, Torous and Firth (2016) cautioned that the soundness of AI-driven treatment planning ought to be rigorously examined through randomised controlled trials before widespread clinical adoption. ...
Integrating Artificial Intelligence (AI) with mental healthcare presents a paradigm shift in diagnosis and treatment planning, offering potential efficiency, accuracy, and personalisation improvements. However, this technological advancement allows for the exploration of a complex array of ethical challenges that demand careful consideration. This research explores the vital ethical dimensions surrounding the adoption of AI in mental health contexts, emphasising the reason for a balanced approach that maximises benefits while mitigating risks. Central to these considerations is the imperative of privacy and data protection. This type of mental health information requires comprehensive robust safeguards to prevent unauthorised access or misuse while allowing for responsible data utilisation to drive AI-powered advancements. The assurance of fairness and non-discrimination in AI systems is critical, as racial bias could exacerbate disparities in mental healthcare access and outcomes. Transparency and explainability emerge as crucial factors in fostering trust and accountability. AI systems must be capable of providing clear rationales for their diagnostic and proposed treatment planning, which aids clinicians and patients to make informed decisions. This transparency is intimately linked to the principles of autonomy and informed consent, requiring that individuals fully understand the role of AI in their treatment and have the agency to accept or decline its use. The integration of AI also necessitates a reevaluation of professional ethics and responsibilities for mental health practitioners. As AI systems assume more significant roles in diagnosis and treatment planning, the boundaries of professional judgment and accountability must be delineated. Moreover, the broader societal implications, including potential changes in public perception of mental healthcare and shifts in the healthcare workforce, warrant careful consideration. Regulatory and governance frameworks play a pivotal role in addressing these ethical challenges. Policymakers face the complex task of developing adaptive regulations that foster innovation while ensuring robust ethical safeguards. This requires a collaborative approach involving clinicians, researchers, ethicists, patients, and technology developers.
... Limitations to this study must be considered. First, the use of a passive control group is a limitation because it has the potential to inflate efficacy estimates via the digital placebo effect (Torous & Firth, 2016). Some contend that waitlists may be better conceptualized as a nocebo condition because the uncertainty of waiting for intervention may exacerbate symptoms and lead to negative Table 3. values are based on non-imputed data; mean differences and effect sizes are derived from ITT analysis (n = 587) using multiple imputation. ...
Background
Dialectical behavior therapy (DBT) is a specialized treatment that has a growing evidence base for binge-spectrum eating disorders. However, cost and workforce capacity limit wide-scale uptake of DBT since it involves over 20 in-person sessions with a trained professional (and six sessions for guided self-help format). Interventions translated for delivery through modern technology offer a solution to increase the accessibility of evidence-based treatments. We developed the first DBT-specific skills training smartphone application ( Resilience : eDBT ) for binge-spectrum eating disorders and evaluated its efficacy in a randomized clinical trial.
Method
Participants reporting recurrent binge eating were randomized to Resilience ( n = 287) or a waitlist ( n = 289). Primary outcomes were objective binge eating episodes and global levels of eating disorder psychopathology. Secondary outcomes were behavioral and cognitive symptoms, psychological distress, and the hypothesized processes of change (mindfulness, emotion regulation, and distress tolerance).
Results
Intention-to-treat analyses showed that the intervention group reported greater reductions in objective binge eating episodes (incidence rate ratio = 0.69) and eating disorder psychopathology ( d = −0.68) than the waitlist at 6 weeks. Significant group differences favoring the intervention group were also observed on secondary outcomes, except for subjective binge eating, psychological distress, and distress tolerance. Primary symptoms showed further improvements from 6 to 12 weeks. However, dropout rate was high (48%) among the intervention group, and engagement decreased over the study period.
Conclusion
A novel, low-intensity DBT skills training app can effectively reduce symptoms of eating disorders. Scalable apps like these may increase the accessibility of evidence-based treatments.
... peutic outcomes, making them a critical component of the modern healthcare landscape [2]. These interventions are particularly noteworthy for their ability to offer personalized treatment plans, often by integrating real-time patient data with advanced algorithms to optimize therapeutic efficacy [3]. ...
Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.
... Although this study did not directly measure perceptions of ChatGPT, the high frequency of use reported (42.2% daily, 40.6% very often) suggests its perceived value. From a broader perspective, research shows that people often have unrealistic expectations of a technology's ability to bring about positive change, akin to a placebo effect observed in digital interventions [61,62]. In the context of ChatGPT, students may develop an illusion of efficacy, fostering dependency. ...
Objective
The adoption of Generative AI in education presents both opportunities and challenges, particularly regarding its potential to foster student dependency. However, the psychological drivers of this dependency remain unclear. This study addresses this gap by applying the Interaction of Person-Affect-Cognition-Execution (I-PACE) model and Basic Psychological Needs (BPN) theory to explore how specific personality traits—neuroticism, self-critical perfectionism, and impulsivity—contribute to AI dependency through needs frustration, negative academic emotions, and reinforced performance beliefs.
Method
Data were collected from 958 university students (Mage = 21.67) across various disciplines. Structural equation modeling (SEM) was used to analyze the relationships among the variables.
Results
Neuroticism, self-critical perfectionism, and impulsivity were found to be significantly associated with increase needs frustration and negative academic emotions, which in turn reinforced students’ positive beliefs about performance of AI tools, deepening their dependency. The study also uncovered complex serial mediation effects, highlighting intricate psychological pathways that drive maladaptive AI use.
Conclusions
This research provides a critical insight into the interplay between personality traits and technology use, shedding light on the nuanced ways in which individual differences influence dependency on generative AI. The findings offer practical strategies for educators to promote balanced AI use and support student well-being in educational settings.
... One meta-analysis showed the efficacy of using smartphone-delivered to reduce both depression and anxiety 33 . However, to what extent these effects are due to the therapy itself rather than using the smartphones and individuals' connection with their smartphones has to be determined 34 . ...
As the internet is becoming more and more accessible and prevalent, there has been growing interest in determining the effect of internet use on human cognition, particularly memory. However, much less is known about how internet use frequency is related to episodic memory, which refers to the memory of past events as opposed to facts (i.e., semantic memory). Episodic memory is very relevant to the internet because of the notion that the internet is a form of transactive memory, which requires people to retrieve how information was accessed (i.e., episodic memory) rather than the information itself (i.e., semantic memory). By analyzing data from 36, 542 participants with 44.06% females and a mean age of 46.63 years old from the Understanding Society using multivariate and univariate analysis of variances (ANOVA), the current study found that the frequency of internet use is positively related to episodic memory (assessed using the immediate recall and delayed word recall tasks). These results provide support to the notion that the internet is a form of transactive memory and the “use it, or lose it” theory.
... Additionally, the fact that mobile health applications are often associated with falsely elevated user satisfaction levels due to individuals' fondness for digital devices, poses a potential bias in this project. 91 Furthermore, the self-selection of participants in the quantitative sample introduces selection bias, as those who volunteered for the study were more likely to have an interest in or perceive potential benefits from using the mobile application. Considering these factors, future research can address some of the limitations identified in this study, thus enhancing the comprehensiveness, rigour and applicability of the findings. ...
Chronic wounds are a growing concern due to aging populations, sedentary lifestyles and increasing rates of obesity and chronic diseases. The impact of such wounds is felt worldwide, posing a considerable clinical, environmental and socioeconomic challenge and impacting the quality of life. The increasing complexity of care requires a holistic approach, along with extensive knowledge and skills. The challenge experienced by health‐care professionals is particularly significant for newly graduate nurses, who face a gap between theory and practice. Digital tools, such as mobile applications, can support wound care by facilitating more precise assessments, early treatment, complication prevention and better outcomes. They also aid in clinical decision‐making and improve healthcare delivery in remote areas. Several mobile applications have emerged to enhance wound care. However, there are no applications dedicated to newly graduate nurses. The aim of this study was to co‐create and evaluate an algorithm for the development of a wound care mobile application supporting clinical decisions for new graduate nurses. The development of this mobile application is envisioned to improve knowledge application and facilitate evidence‐based practice. This study is part of a multiphase project that adopted a pragmatic epistemological approach, using the ‘Knowledge‐to‐Action’ conceptual model and Duchscher's Stages of Transition Theory. Following a scoping review, an expert consensus, and stakeholder meetings, this study was pursued through a sequential exploratory mixed methods design carried out in two phases. In the initial phase, 21 participants engaged in semi‐structured focus groups to explore their needs regarding clinical decision support in wound care, explore their perceptions of the future mobile application's content and identify and categorize essential components. Through descriptive analysis, five overarching themes emerged, serving as guiding principles for conceptual data model development and refinement. These findings confirmed the significance of integrating a comprehensive glossary complemented by photos, ensuring compatibility between the mobile application and existing documentation systems, and providing quick access to information to avoid burdening work routines. Subsequently, the algorithm was created from the qualitative data collected. The second phase involved presenting an online SurveyMonkey® questionnaire to 34 participants who were not part of the initial phase to quantitatively measure the usability of this algorithm among future users. This phase revealed very positive feedback regarding the usability [score of 6.33 (±0.19) on a scale of 1–7], which reinforces its quality. The technology maturation process can now continue with the development of a prototype and subsequent validation in a laboratory setting.
... On the one hand, participation in the study itself could have led to improvements through the impulse for stronger selfmanagement. On the other hand, as shown in studies for psychological apps, a digital placebo effect may have led to improvements in the control group [27]. Despite the improvements achieved in the control group, the results in the group comparison show a clear superiority in favor of the intervention. ...
Introduction: Endometriosis can significantly impair the quality of life of those affected. Multimodal self-help measures are recommended but are often difficult to access. Smartphone apps have been shown to improve the quality of life for other conditions with chronic pain. The aim of this study was to examine the impact of the Endo-App (Endo Health GmbH, Chemnitz, Germany) on both disease-related quality of life and symptoms of endometriosis affecting it.
Methods: In the present randomized, controlled pilot study, the impact of utilizing the Endo-App on the quality of life among a sample of 122 women affected by endometriosis is assessed. To measure the changes over a 12-week period, the study incorporates the validated Endometriosis Health Profile (EHP-5 and EHP-30) questionnaire from Oxford University, among other assessment tools.
Results: The use of the Endo-App leads to significant changes in the following areas after 12 weeks compared to the control group: pain disability, pain self-efficacy, fatigue, depressive symptoms, and Endometriosis Health Profile scores. The EHP-5 score from T0 to T12 is reduced by -16.76 (p-value of the Mann-Whitney U test (pU) = 0.008), and the EHP-30 score by -15.48 (pU = 0.004). The results remain significant in sensitivity analyses. The effect size of Cohen's d was in the medium range.
Conclusion: In summary, the Endo-App improves both physical and psychological symptoms and the patient's self-efficacy. The Endo-App contributes to improving endometriosis care in Germany and enables women suffering from endometriosis to significantly increase their quality of life.
... In contrast, a study by Poppelaars et al. [68] showed that minimal use of digital interventions by high school students with (sub)clinical depressive symptoms resulted in symptom reduction. Digital placebo, a phenomenon similar to drug placebo, described by Torous et al. [69], suggests that the latter finding might also be applicable to this study. This would mean that having access to a digital intervention aimed at reducing depressive symptoms might already lead to relief of the existing burden and to symptom reduction. ...
Background
Depression is a common mental disorder. Detecting (sub)clinical depressive symptoms in adolescents at an early stage and offering a low-threshold early intervention can minimize the risk of serious and/or long-term depression. As such, a digital intervention can be a low-threshold preventive and early intervention. This study aims to examine whether the Boost My Mood (BMM)-app is a suitable preventive early intervention for adolescents with (sub)clinical depressive symptoms.
Methods
This naturalistic single-arm evaluation study (N = 50) was conducted in adolescents aged 16–21 with (sub)clinical depressive symptoms. Furthermore, the BMM-app was studied in relation to anxiety, worrying, stress, and sleeping problems. An exploratory objective was to determine whether positive expectations and social support are related to app use.
Results
The study showed a significant decrease in not only depressive symptoms, but also anxiety, worrying and stress while using the BMM-app. Sleeping problems did not significantly decrease over time while using the BMM-app. The degree of use of the BMM-app and telling significant others about using the BMM-app were both not related to a decrease in depressive symptoms. The BMM-app was used significantly more when the adolescent had told relatives about their depressive symptoms.
Conclusions
A digital intervention, such as the BMM-app, can be a low-threshold preventive and early intervention for adolescents with (sub)clinical depressive symptoms. Beneficial effects of the BMM-app were reported on depressive symptoms as well as other aspects of quality of life, such as anxiety, worrying, and stress. Whereas several factors may have played a role in the current findings on depressive symptoms, there are reasons to assume that part of the reduction in symptoms could be attributed to the BMM-app. Although no causality can be assumed, this study is a first step in the implementation of preventive apps in mental health care.
... Fifth, a potential limitation is the digital placebo effect [137]. In this unblinded trial, participants might attribute improvements to using an mHealth intervention rather than interventionist ingredients. ...
... 14 Smartphonedelivered ICBT, such as the 'Perspectives' application (app), offers an even more accessible and flexible method to provide evidence-based care, particularly given the widespread ownership of smartphones. 15 By delivering therapy through digital platforms, individuals with psychological conditions, like BDD, can receive treatment at their convenience, potentially mitigating the impact of stigma and shame associated with seeking traditional therapy. 16 Despite the potential of ICBT and smartphone-delivered interventions, knowledge gaps persist regarding their effectiveness, cost-effectiveness and feasibility, particularly when implemented in real-life clinical settings. ...
Objective: To evaluate the effectiveness, cost-effectiveness and feasibility of internet-based Cognitive Behavioural Therapy (CBT) in the treatment of body dysmorphic disorder. Method: The systematic review was conducted from August 19 to September 22, 2023, and comprised search on Cochrane Library, Embase, Google Scholar, PubMed, PsycINFO and Web of Science databases using specific key words for studies published in the English language from 2010 onwards. Grey literature and pertinent conference proceedings were also searched to include as many studies as possible that investigated internet-based cognitive behavioural therapy in the treatment of body dysmorphic disorder. Data extraction was done, and the selected studies were subjected to quality assessment, followed by a narrative synthesis of the findings. Results: Out of the 6,837 studies initially identified, 8(0.11%) were analysed in detail. Of the 8 studies, 4(50%) were RCTs, while 5(62.5%) had been conducted in Sweden. Therapist-guided internet-based cognitive behavioural therapy interventions consistently demonstrated efficacy with respect to reducing body dysmorphic disorder symptom severity, improving insight, and enhancing quality of life. Cost-effectiveness analyses highlighted the favourable economic aspect of internet-based cognitive behavioural therapy. Feasibility and acceptability were demonstrated by high participant engagement and satisfaction. Conclusion: Internet-based cognitive behavioural therapy showed promise in addressing the treatment gap in body dysmorphic disorder care, offering accessible, cost-effective and feasible interventions. Key Words: Body dysmorphic disorder, Cost-effectiveness, Efficacy, Feasibility, Internet-based cognitive behavioural therapy.
... However, a fourth point is that MPA pilot studies can have promising results that dissipate once compared with a control group, introducing potential bias (digital placebo effect). 75 Another critical insight from this review is that MPAs may not be well-suited for every SUD stage. When considering brain disease model of addiction by Koob and Volkow, 76 most MPAs identified were targeting the preoccupation/anticipation stage. ...
Mobile phone applications (MPAs) for substance use disorder (SUD) treatment are increasingly used by patients. Although pilot studies have shown promising results, multiple previous systematic reviews noted insufficient evidence for MPA use in SUD treatment—many of the previously published reviews evaluated different trials. Subsequently, we aimed to conduct an umbrella review of previously published reviews investigating the efficacy of MPAs for SUD treatment, excluding nicotine/tobacco because umbrella reviews have been done in this population and the nicotine/tobacco MPA approach often differs from SUD-focused MPAs. No previous reviews have included a statistical meta-analysis of clinical trials to quantify an estimated overall effect. Seven reviews met inclusion criteria, and 17 unique studies with available data were taken from those reviews for the meta-analysis. Overall, reviews reported a lack of evidence for recommending MPAs for SUD treatment. However, MPA-delivered recovery support services, cognitive behavioral therapy, and contingency management were identified across multiple reviews as having promising evidence for SUD treatment. Hedges g effect size for an MPA reduction in substance use—related outcomes relative to the control arm was insignificant (0.137; 95% CI, −0.056 to 0.330; P=.16). In subgroup analysis, contingency management (1.29; 95% CI, 1.088-1.482; τ²=0; k=2) and cognitive behavioral therapy (0.02; 95% CI, 0.001-0.030; τ²=0; k=2) were significant. Although contingency management’s effect was large, both trials were small (samples of 40 and 30). This review includes an adapted framework for the American Psychiatric Association’s MPA guidelines that clinicians can implement to review MPAs critically with patients.
... 9 In addition to uncertainties regarding market access and business models, there are ongoing discussions about standards for evidence generation for DTx-a context in which researchers face unique challenges such as "digital placebo effects, " lack of patient/provider experience, or varying digital literacy in patient populations. 10 Analyses to date reveal varying levels of evidence for FDA-regulated DTx, with potential limitations in generalizability due to age-specific and language-specific recruitment in the underlying trials. 11 Moreover, while DTx often include sensor-based technologies and are uniquely equipped to generate real-world data (RWD) and real-world evidence (RWE), 7 the research community has yet to reach a consensus on best practices. ...
Digital therapeutics (DTx), evidence-based software interventions for preventing, managing, or treating medical disorders, have rapidly evolved with healthcare's shift toward online, patient-centric solutions. This study scrutinizes DTx clinical trials from 2005 to 2022, analyzing their growth, funding, underlying medical specialties, and other R&D characteristics, using ClinicalTrials.gov data. Our analysis includes trials categorized via the ICD-11 system, covering active, recruiting, or completed studies and considering trials listing multiple conditions. In analyzing 5,889 registered DTx trials, we document a more than five-fold increase in such trials since 2011, and a compound annual growth rate of 22.82% since 2005. While most trials were single-center, the median number of study subjects increased in recent years, driven by larger interventional trials. The key disciplines driving this growth were psychiatry, neurology, oncology, and endocrinology. Mental health dominated DTx trials in recent years, led by neurocognitive disorders, substance abuse disorders, and mood disorders. Industry funding varied across disciplines and was particularly high in visual system diseases and dermatology. DTx trials have surged since 2005, accelerated by recent growth in mental health trials. These trends mirror developments toward remote healthcare delivery, amplified by digital health investments during the COVID-19 pandemic. Growing numbers of participants in DTx trials point to increased demand for more robust trials. However, because most trials are single-center and country-specific, more international cooperation and harmonized evaluation standards will be essential for DTx trials to become more efficient and provide validation across countries, health systems, and groups of individuals.
... While there is no single definition of what constitutes a DTC healthcare product or service, it typically involves consumers initiating the process of ordering a product or service, often online, with little to no direct involvement from a healthcare professional [1]. Examples include consumer neurostimulation devices [2], digital mental health apps [3], and laboratory tests [4]. Many, but not all, DTC health products are reliant on digital health platforms for their business model or product functionality. ...
An increasing number of health products and services are being offered on a direct-to-consumer (DTC) basis. To date, however, scholarship on DTC healthcare products and services has largely proceeded in a domain-specific fashion, with discussions of relevant ethical challenges occurring within specific medical specialties. The present study therefore aimed to provide a scoping review of ethical issues raised in the academic literature across types of DTC healthcare products and services. A systematic search for relevant publications between 2011–2021 was conducted on PubMed and Google Scholar using iteratively developed search terms. The final sample included 86 publications that discussed ethical issues related to DTC healthcare products and services. All publications were coded for ethical issues mentioned, primary DTC product or service discussed, type of study, year of publication, and geographical context. We found that the types of DTC healthcare products and services mentioned in our sample spanned six categories: neurotechnology (34%), testing (20%), in-person services (17%), digital health tools (14%), telemedicine (13%), and physical interventions (2%). Ethical arguments in favor of DTC healthcare included improved access (e.g., financial, geographical; 31%), increased autonomy (29%), and enhanced convenience (16%). Commonly raised ethical concerns included insufficient regulation (72%), questionable efficacy and quality (70%), safety and physical harms (66%), misleading advertising claims (56%), and privacy (34%). Other frequently occurring ethical concerns pertained to financial costs, targeting vulnerable groups, informed consent, and potential burdens on healthcare providers, the healthcare system, and society. Our findings offer insights into the cross-cutting ethical issues associated with DTC healthcare and underscore the need for increased interdisciplinary communication to address the challenges they raise.
... In the CLIMB trial, the intervention arm showed no improvement in psychotic or mood symptoms compared to the control. These randomized trials are among the few trials comparing a digital intervention against a control digital application, prompting questions of whether other smartphone-based digital studies have buoyed benefits against standard treatment due to the presence of an application rather than the actual content of the digital application [46,47]. These studies indicate a need to understand the mechanisms of action that contribute to even modest benefits from digital therapeutic interventions. ...
Purpose of Review
Schizophrenia presents a significant mental health challenge requiring innovative solutions for relapse prevention, self-management, and health promotion. Patients face an excess mortality gap, driven by increased rates of chronic health conditions, exacerbated in low-resource settings. Digital interventions are a promising avenue to address the multifaceted needs of individuals with schizophrenia. This narrative review synthesizes evidence from digital intervention trials for schizophrenia published from January 2020 to June 2023.
Recent Findings
23 studies were identified, encompassing smartphone applications and web-based platforms to mitigate symptom severity, prevent relapse, and promote physical health. Key developments thus far have shown reduced symptom burden, and enhanced medication adherence and physical activity engagement. Despite more than a decade of research on digital interventions, many trials in this review continued to focus on acceptability and feasibility, with emphasis on patient uptake. This suggests the field has shown limited advancement in effectiveness studies of digital interventions.
Summary
As the field evolves, further fully powered effectiveness studies, greater emphasis on implementation studies for digital tools for schizophrenia, and attention on digital health equity and evidence generation among those in lower-income countries are warranted. These findings hold implications for clinicians, researchers, and policymakers towards optimizing digital care for individuals with schizophrenia.
... A fourth consideration is whether the treatment condition is masked and in such a way that expectancy is likely to be matched between focal and control conditions. This is arguably the characteristic feature of an ideal placebo control and any control conditions capable of clarifying intervention effects beyond non-specific factors 31,32 . It is important to acknowledge that clinical trialists, despite their best intentions, may or may not succeed in matching expectancy, and the development of psychotherapy placebos remains a challenging (and some might say impossible) 9,33 task. ...
Hundreds of randomized controlled trials (RCTs) have tested the efficacy of mobile health (mHealth) tools for a wide range of mental and behavioral health outcomes. These RCTs have used a variety of control condition types which dramatically influence the scientific inferences that can be drawn from a given study. Unfortunately, nomenclature across mHealth RCTs is inconsistent and meta-analyses commonly combine control conditions that differ in potentially important ways. We propose a typology of control condition types in mHealth RCTs. We define 11 control condition types, discuss key dimensions on which they differ, provide a decision tree for selecting and identifying types, and describe the scientific inferences each comparison allows. We propose a five-tier comparison strength gradation along with four simplified categorization schemes. Lastly, we discuss unresolved definitional, ethical, and meta-analytic issues related to the categorization of control conditions in mHealth RCTs.
... Furthermore, the use of social media and other forms of digital media on a global scale have a significant influence on how people share and perceive information about various professions, including those in public health (Weijs et al., 2019) Although there are potential positive outcomes from utilising social media to spread awareness about the importance of exercise and maintaining a healthy lifestyle, it could still have its own weaknesses and limitations. Due to the fact that most individuals have a strong attachment for their digital devices and high expectations on their capabilities, there is a risk of spreading misleading information, which could lead to digital placebo effect seen from mobile health interventions (Torous & Firth, 2016;Wang et al., 2019). ...
Social media has become one of the crucial parts of everyday life, and it has also emerged as an impactful platform for promoting exercise and healthy lifestyles to the public. The study provides a review of previous literatures on the use of social media to promote the importance of exercise, healthy lifestyles and highlighting some of the key findings and trends in this area. The study also explores the various ways in which social media can be an advantage to promote exercise and healthy living, such as through social support, community building, and personalized feedback. Challenges and limitations associated with using social media, such as the risk of misinformation and the potential for social comparison and negative self-image are also addressed in this study. At the end of this study, the researcher offers some recommendations and conclusion for future research and practice for this study, such as the need for more evidence-based interventions that leverage the strengths of social media while minimizing its limitations. Overall, this study manifests the public's ability to use social media platforms to promote exercise and healthy lifestyles, and it draws attention the importance of ongoing research and innovation in this rapidly evolving field.
... 18 Few studies assessing mental health apps' efficacy incorporate active control groups and instead rely on waitlist 19 or treatment as usual controls. 20 Given the potential of a digital placebo effect 21 which may improve outcomes in the group offered the digital interventions compared to that not, 22 assessing the effect size of apps remains challenging today. For example, a meta-review of 14 meta-analyses points to the importance of considering the rigor of comparison groups as the magnitude of the effect of mental health apps' efficacy diminished as control groups became more robust, 18 a trend further corroborated by two meta-analyses. ...
Objectives
Despite the proliferation of mobile mental health apps, evidence of their efficacy around anxiety or depression is inadequate as most studies lack appropriate control groups. Given that apps are designed to be scalable and reusable tools, insights concerning their efficacy can also be assessed uniquely through comparing different implementations of the same app. This exploratory analysis investigates the potential to report a preliminary effect size of an open-source smartphone mental health app, mindLAMP, on the reduction of anxiety and depression symptoms by comparing a control implementation of the app focused on self-assessment to an intervention implementation of the same app focused on CBT skills.
Methods
A total of 328 participants were eligible and completed the study under the control implementation and 156 completed the study under the intervention implementation of the mindLAMP app. Both use cases offered access to the same in-app self-assessments and therapeutic interventions. Multiple imputations were utilized to impute the missing Generalized Anxiety Disorder-7 and Patient Health Questionnaire-9 survey scores of the control implementation.
Results
Post hoc analysis revealed small effect sizes of Hedge's g = 0.34 for Generalized Anxiety Disorder-7 and Hedge's g = 0.21 for Patient Health Questionnaire-9 between the two groups.
Conclusions
mindLAMP shows promising results in improving anxiety and depression outcomes in participants. Though our results mirror the current literature in assessing mental health apps’ efficacy, they remain preliminary and will be used to inform a larger, well-powered study to further elucidate the efficacy of mindLAMP.
... As such, it was unclear whether investigators or patients were blind to participant allocation. Combined, it is unclear whether effect sizes were owed to the effectiveness of specific therapeutic constituents of the treatments under scrutiny or owed to placebo responses [20]. ...
Purpose
Placebo terminology and their applications are well embedded in clinical and research contexts. This review seeks to clarify the principles of good placebo control design and to offer recommendations for improving placebos in digital mental healthcare.
Recent Findings
Terminological confusions associated with understanding the function of placebos in pharmacology and psychotherapy reveal an underappreciation of the challenges associated with designing adequate placebo controls in clinical trials. It would be surprising if similar challenges did not arise with the testing of digital therapeutics, and emerging evidence shows an attendant lack of placebo literacy in digital health.
Summary
Despite the burgeoning health app economy with tens of thousands of apps now available to download by consumers, few researchers have interrogated what constitutes a good placebo control in digital healthcare. This review sought to disambiguate placebo concepts and to offer recommendations for improving placebo design to advance and future proof the field digital therapeutics.
... Previous studies have also found evidence that performance expectancy was positively associated with intention to use mHealth apps [101]. Hence, while an Active Control condition was used to limit the presence of digital placebo, as per Gruszka et al. [102]'s recommendation, simply participating in the study and engaging in mental wellbeing topics might contribute to the improvement of anxiety and depressive symptoms [103]. Third, we underestimated the relevance of CBT techniques utilized in the "Procrastination" programme for anxiety outcomes and thus did not expect that it would be as effective in reducing anxiety among young adults. ...
Digital self-guided mobile health [mHealth] applications are cost-effective, accessible, and well-suited to improve mental health at scale. This randomized controlled trial [RCT] evaluated the efficacy of a recently developed mHealth programme based on cognitive-behavioral therapy [CBT] principles in improving worry and anxiety. We also examined psychological mindedness [PM] as a mediator by which app engagement is thought to improve outcomes. The Intervention group completed a 2-week “Anxiety and Worry” programme with daily CBT-informed activities, while the active waitlist-control completed a matched 2-week mHealth programme on procrastination. Participants filled out the Generalized Anxiety Disorder [GAD-7], Patient Health Questionnaire [PHQ-9], and Psychological Mindedness Scale [PMS] at baseline, post-intervention, and 2-week follow-up. App engagement was measured at post-intervention only. Contrary to prediction, the Intervention group did not perform better than the Active Control group; both groups showed significant improvements on anxiety and depressive symptoms from baseline to follow-up. From post-intervention to follow-up, only the Intervention group showed further improvements for anxiety symptoms. Higher engagement with the mHealth app predicted lower anxiety and depressive symptoms at follow-up, and this relationship was fully mediated by psychological mindedness. This study provides evidence that [a] engaging in a CBT mHealth programme can reduce anxiety and worry, and [b] Psychological mindedness is a potential pathway by which engaging with a mHealth app improves anxiety and depressive symptoms. While overall effect sizes were small, at the population level, these can make significant contributions to public mental health.
This systematic review and meta‐analysis examines the effectiveness of science‐based mobile apps for reducing anxiety. A systematic review was employed to identify experimental studies on science‐based mobile applications developed anxiety disorders. International databases such as PubMed, Web of Science, SCOPUS and ProQuest were searched to locate relevant articles. After the systematic review, 16 ( k = 20) experimental studies on the effectiveness of science‐based mobile apps for reducing anxiety that met the inclusion criteria were included in the meta‐analysis study. The analysis findings concluded that science‐based mobile apps have a noteworthy impact on reducing anxiety symptoms. Additionally, the moderator analysis indicated that various factors, including participant characteristics (such as gender and age), methodological factors (such as the measurement tool for anxiety and type of control group) and the intervention duration, play a crucial role in this impact. These findings suggest that science‐based mobile apps can provide a helpful tool for individuals seeking to manage their anxiety symptoms and that a range of therapeutic techniques, such as mindfulness, cognitive restructuring and psychoeducation, can be effectively employed in these apps.
Background
Chronic kidney disease (CKD) is a serious condition affecting millions of individuals worldwide. Adherence to medication regimens among patients with CKD is often suboptimal, leading to poor health outcomes. In recent years, mobile apps have gained popularity as a promising tool to improve medication adherence and self-management in various chronic diseases.
Objective
This study aimed to evaluate the effectiveness of mobile apps to improve medication adherence among patients with CKD (including end-stage and renal replacement therapy).
Methods
A systematic search was conducted using Scopus, Cochrane, PubMed, and EBSCOhost to include eligible articles that studied mobile apps to improve medication adherence among patients with CKD. The quality of the selected studies was evaluated using the Newcastle‒Ottawa Scale and the Cochrane risk-of-bias tool.
Results
Out of 231 relevant articles, only 9 studies were selected for this systematic review. Based on Newcastle‒Ottawa Scale, 7 were deemed to be of high quality, while others were of fair quality. The Cochrane risk-of-bias tool indicated a low to moderate risk of bias across the included studies. Most of the included studies had a randomized controlled design. Of the 9 selected studies, 3 papers represented medication adherence by a coefficient of 10 variability of tacrolimus, 3 papers used adherence measurement scales to calculate the score for assessing medication adherence, 2 papers represented medication adherence by self-reporting, 2 papers represented medication adherence using electronic monitoring, and 1 represented medication adherence by pill count. The mobile apps were identified as Transplant Hero (Transplant Hero LLC), Perx (Perx Health), Smartphone Medication Adherence Saves Kidneys (developed by John McGillicuddy), Adhere4U (developed by Ahram Han), My Dialysis (developed by Benyamin Saadatifar), Kidney Love (developed by National Kidney foundation), and iCKD (developed by Dr Vivek Kumar). Of these apps, 3 focused on evaluating Transplant Hero, while the remaining investigated each of the other mentioned apps individually. The apps use various strategies to promote medication adherence, including reminders, gamification, patient education, and medication monitoring. A majority, 5 out of 9 mobile apps, had a statistically significant (P<.05) effect on medication adherence. There was strong evidence for a positive effect of interventions focusing on games and reminders combined with electronic medication tray monitoring and patient education.
Conclusions
Mobile apps effectively improved medication adherence in patients with CKD, but low evidence and short intervention duration warrant caution. Future research should identify ideal features, provider costs, and user-friendly, secure apps.
Brain oscillatory activity and its role as a biomarker in mental health and human behavioral mechanisms stands as an unexplored tool to explain the placebo effect. This systematic review and meta-analysis characterize, for the first time, the neural mechanistic biomarkers of placebo effect in neurorehabilitation. A systematic literature search based on PRISMA guidelines was conducted in PubMed, Embase, and Cochrane Library including randomized controlled trials (RCTs), and cross-over trials up to August 2023. The review included studies reporting brain oscillations in resting state as outcome in placebo-controlled neurorehabilitation trials. A qualitative, semi-quantitative, quantitative analysis was performed using minimal statistical information from each study and calculating effect sizes of absolute power differences between placebo and active intervention groups using Hedges’ g statistic method. The analysis included 63 studies: 5 (180 healthy subjects) and 58 (1758 patients with neurological disorders). In healthy population, placebo interventions showed an increase in alpha power when comparing versus no intervention (g = 0.45, 95% CI [0.09; 0.8]). In subjects with neurological disorders sham intervention showed increase in alpha frontal (g = 0.08, 95% CI [0.07; 0.08] ), alpha central (g = 0.55, 95% CI [0.47; 0.65]), alpha parietal (g = 0.28, 95% CI [0.18; 0.44]), beta central (g = 1.31, 95% CI [1.06; 1.63]), and theta central (g = 0.58, 95% CI [0.46; 0.72]). Interestingly, these effects became non-significant when comparing with the active interventions. In both populations, the enhancement of alpha oscillations in fronto-central regions emerged as the primary neural biomarker of the placebo effect. Furthermore, increase in beta and theta bands within the same brain regions were also noted as potential biomarkers, particularly in non-healthy subjects. Intriguingly, these effects were reversed when compared to active rehabilitation interventions, suggesting that active rehabilitation techniques also encompass the placebo effect. Our novel results show that placebo neural effects depend on the brain oscillatory baseline (healthy vs. patient populations), and they seem to unmask a more homeostatic salutogenic rhythm, such as alpha oscillations in healthy subjects and theta and beta oscillations in patient populations.
Background
Globally, students face increasing mental health challenges, including elevated stress levels and declining well-being, leading to academic performance issues and mental health disorders. However, due to stigma and symptom underestimation, students rarely seek effective stress management solutions. Conversational agents in the health sector have shown promise in reducing stress, depression, and anxiety. Nevertheless, research on their effectiveness for students with stress remains limited.
Objective
This study aims to develop a conversational agent–delivered stress management coaching intervention for students called MISHA and to evaluate its effectiveness, engagement, and acceptance.
Methods
In an unblinded randomized controlled trial, Swiss students experiencing stress were recruited on the web. Using a 1:1 randomization ratio, participants (N=140) were allocated to either the intervention or waitlist control group. Treatment effectiveness on changes in the primary outcome, that is, perceived stress, and secondary outcomes, including depression, anxiety, psychosomatic symptoms, and active coping, were self-assessed and evaluated using ANOVA for repeated measure and general estimating equations.
Results
The per-protocol analysis revealed evidence for improvement of stress, depression, and somatic symptoms with medium effect sizes (Cohen d=−0.36 to Cohen d=−0.60), while anxiety and active coping did not change (Cohen d=−0.29 and Cohen d=0.13). In the intention-to-treat analysis, similar results were found, indicating reduced stress (β estimate=−0.13, 95% CI −0.20 to −0.05; P<.001), depressive symptoms (β estimate=−0.23, 95% CI −0.38 to −0.08; P=.003), and psychosomatic symptoms (β estimate=−0.16, 95% CI −0.27 to −0.06; P=.003), while anxiety and active coping did not change. Overall, 60% (42/70) of the participants in the intervention group completed the coaching by completing the postintervention survey. They particularly appreciated the quality, quantity, credibility, and visual representation of information. While individual customization was rated the lowest, the target group fitting was perceived as high.
Conclusions
Findings indicate that MISHA is feasible, acceptable, and effective in reducing perceived stress among students in Switzerland. Future research is needed with different populations, for example, in students with high stress levels or compared to active controls.
Trial Registration
German Clinical Trials Register DRKS 00030004; https://drks.de/search/en/trial/DRKS00030004
Meditation apps are the most commonly used mental health apps. However, the optimal dosing of app-delivered meditation practice has not been established. We examined whether the distribution of meditation practices across a day impacted outcomes in a distressed population. We investigated the effects of meditation practice frequency in a 2-week compassion-based meditation intervention delivered via the Healthy Minds Program app. Undergraduates with clinically elevated depression and/or anxiety (N = 351) were randomized to a massed (one 20-min meditation per day) or distributed condition (two 10-min meditations per day). Psychological distress (primary outcome; composite of depression and anxiety), experiential avoidance, fear of missing out, loneliness, and self-compassion were assessed pre- and post-intervention. Psychological distress, loneliness, and informal meditation practice were also assessed daily. Practice time and frequency were assessed using app data. Results support feasibility of the study design, success of the manipulation, and acceptability of the intervention. Pooled across conditions, participants exhibited pre–post improvements on all outcomes (absolute value of ds = 0.12–0.63, p ≤ .010) and trajectories of improvement on daily distress and loneliness (p ≤ .010). No between-group differences were observed on changes in pre–post or daily measures (ps = .158–.729). When total amount of meditation practice per day is held constant, the distribution of practice may not influence outcomes for distressed beginners. Although only a first test of dose frequency effects, findings support flexibility in the distribution of meditation throughout the day, which may increase accessibility.
Background
Although adolescents report high levels of stress, they report engaging in few stress management techniques. Consequently, developing effective and targeted programs to help address this transdiagnostic risk factor in adolescence is particularly important. Most stress management programs for adolescents are delivered within schools, and the evidence for these programs is mixed, suggesting a need for alternative options for stress management among adolescents.
Objective
The aim of the study is to test the short-term effects of a self-guided digital mental health intervention (DMHI) designed for adolescents on perceived stress and rumination (ie, brooding).
Methods
This was a 12-week, 2-arm decentralized randomized controlled trial of adolescents aged 13 to 17 years who presented with elevated levels of perceived stress and brooding. Participants were randomly assigned to engage with a self-guided DMHI (Happify for Teens) or to a waitlist control. Participants assigned to the intervention group were given access to the program for 12 weeks. Happify for Teens consists of various evidence-based activities drawn from therapeutic modalities such as cognitive behavioral therapy, positive psychology, and mindfulness, which are then organized into several programs targeting specific areas of concern (eg, Stress Buster 101). Participants in the waitlist control received access to this product for 12 weeks upon completing the study. Participants in both groups completed measures of perceived stress, brooding, optimism, sleep disturbance, and loneliness at baseline, 4 weeks, 8 weeks, and 12 weeks. Changes in outcomes between the intervention and waitlist control groups were assessed using repeated-measures multilevel models.
Results
Of the 303 participants included in data analyses, 132 were assigned to the intervention and 171 to the waitlist. There were significantly greater improvements in the intervention condition for perceived stress (intervention: B=–1.50; 95% CI –1.82 to –1.19; P<.001 and control: B=–0.09; 95% CI –0.44 to 0.26; P=.61), brooding (intervention: B=–0.84; 95% CI –1.00 to –0.68; P<.001 and control: B=–0.30; 95% CI –0.47 to –0.12; P=.001), and loneliness (intervention: B=–0.96; 95% CI –1.2 to –0.73; P<.001 and control: B=–0.38; 95% CI: –0.64 to –0.12; P=.005) over the 12-week study period. Changes in optimism and sleep disturbance were not significantly different across groups (Ps≥.096).
Conclusions
Happify for Teens was effective at reducing perceived stress, rumination, and loneliness among adolescents over 12 weeks when compared to a waitlist control group. Our data reveal the potential benefits of DMHIs for adolescents, which may present a more scalable, destigmatized, and cost-effective alternative to school-based programs.
Trial Registration
ClinicalTrials.gov NCT04567888; https://clinicaltrials.gov/ct2/show/NCT04567888
International Registered Report Identifier (IRRID)
RR2-10.2196/25545
Background
Digital mental health interventions (DMHIs) may reduce treatment access issues for those experiencing depressive and/or anxiety symptoms. DMHIs that incorporate relational agents may offer unique ways to engage and respond to users and to potentially help reduce provider burden. This study tested Woebot for Mood & Anxiety (W-MA-02), a DMHI that employs Woebot, a relational agent that incorporates elements of several evidence-based psychotherapies, among those with baseline clinical levels of depressive or anxiety symptoms. Changes in self-reported depressive and anxiety symptoms over 8 weeks were measured, along with the association between each of these outcomes and demographic and clinical characteristics.
Methods
This exploratory, single-arm, 8-week study of 256 adults yielded non-mutually exclusive subsamples with either clinical levels of depressive or anxiety symptoms at baseline. Week 8 Patient Health Questionnaire-8 (PHQ-8) changes were measured in the depressive subsample (PHQ-8 ≥ 10). Week 8 Generalized Anxiety Disorder-7 (GAD-7) changes were measured in the anxiety subsample (GAD-7 ≥ 10). Demographic and clinical characteristics were examined in association with symptom changes via bivariate and multiple regression models adjusted for W-MA-02 utilization. Characteristics included age, sex at birth, race/ethnicity, marital status, education, sexual orientation, employment status, health insurance, baseline levels of depressive and anxiety symptoms, and concurrent psychotherapeutic or psychotropic medication treatments during the study.
Results
Both the depressive and anxiety subsamples were predominantly female, educated, non-Hispanic white, and averaged 38 and 37 years of age, respectively. The depressive subsample had significant reductions in depressive symptoms at Week 8 (mean change =—7.28, SD = 5.91, Cohen’s d = -1.23, p < 0.01); the anxiety subsample had significant reductions in anxiety symptoms at Week 8 (mean change = -7.45, SD = 5.99, Cohen’s d = -1.24, p < 0.01). No significant associations were found between sex at birth, age, employment status, educational background and Week 8 symptom changes. Significant associations between depressive and anxiety symptom outcomes and sexual orientation, marital status, concurrent mental health treatment, and baseline symptom severity were found.
Conclusions
The present study suggests early promise for W-MA-02 as an intervention for depression and/or anxiety symptoms. Although exploratory in nature, this study revealed potential user characteristics associated with outcomes that can be investigated in future studies.
Trial Registration
This study was retrospectively registered on ClinicalTrials.gov (#NCT05672745) on January 5th, 2023.
The mental health care available for depression and anxiety has recently undergone a major technological revolution, with growing interest towards the potential of smartphone apps as a scalable tool to treat these conditions. Since the last comprehensive meta‐analysis in 2019 established positive yet variable effects of apps on depressive and anxiety symptoms, more than 100 new randomized controlled trials (RCTs) have been carried out. We conducted an updated meta‐analysis with the objectives of providing more precise estimates of effects, quantifying generalizability from this evidence base, and understanding whether major app and trial characteristics moderate effect sizes. We included 176 RCTs that aimed to treat depressive or anxiety symptoms. Apps had overall significant although small effects on symptoms of depression (N=33,567, g=0.28, p<0.001; number needed to treat, NNT=11.5) and generalized anxiety (N=22,394, g=0.26, p<0.001, NNT=12.4) as compared to control groups. These effects were robust at different follow‐ups and after removing small sample and higher risk of bias trials. There was less variability in outcome scores at post‐test in app compared to control conditions (ratio of variance, RoV=–0.14, 95% CI: –0.24 to –0.05 for depressive symptoms; RoV=–0.21, 95% CI: –0.31 to –0.12 for generalized anxiety symptoms). Effect sizes for depression were significantly larger when apps incorporated cognitive behavioral therapy (CBT) features or included chatbot technology. Effect sizes for anxiety were significantly larger when trials had generalized anxiety as a primary target and administered a CBT app or an app with mood monitoring features. We found evidence of moderate effects of apps on social anxiety (g=0.52) and obsessive‐compulsive (g=0.51) symptoms, a small effect on post‐traumatic stress symptoms (g=0.12), a large effect on acrophobia symptoms (g=0.90), and a non‐significant negative effect on panic symptoms (g=–0.12), although these results should be considered with caution, because most trials had high risk of bias and were based on small sample sizes. We conclude that apps have overall small but significant effects on symptoms of depression and generalized anxiety, and that specific features of apps – such as CBT or mood monitoring features and chatbot technology – are associated with larger effect sizes.
Background
The current body of knowledge highlights the potential role of mobile technology as a medium to deliver support for psychological and physical health. This study evaluated the influence of mobile technology support on depressive symptoms and physical activity in female university students.
Methods
A block randomized controlled trial design with a single site was used. Ninety-nine participants were block-randomized into 3 arms: Experimental Group 1 (emotional and informational support group), Experimental Group 2 (informational support group), and the control group. Interventions were delivered via mobile technology for 2 weeks. Data on depressive symptoms and physical activity were collected from 84 participants at baseline and on Days 8 and 15. Data analyses included descriptive statistics, t tests, one-way analysis of variance, and repeated-measures analysis of variance.
Results
This study showed no interaction effect of time and group on depressive symptom scores and physical activity, considering the emotional and informational support from mobile technology. However, Experimental Group 1 exhibited a significant reduction in depressive symptoms during the first week of the study compared to Experimental Group 2 and the control group. While physical activity in Experimental Group 2 and control group increased only during the first week of the study and subsequently decreased, Experimental Group 1 showed an initial increase during the first week that was sustained into the second week.
Conclusions
Since informational and emotional support showed a strong effect over a short period of time, mobile technology offering emotional support could be used to provide crisis interventions for depression among young women when a short-term impact is required.
Background
Primary headaches, including migraine and tension-type headaches, are widespread and have a social, physical, mental, and economic impact. Among the key components of treatment are behavior interventions such as lifestyle modification. Scalable conversational agents (CAs) have the potential to deliver behavior interventions at a low threshold. To our knowledge, there is no evidence of behavioral interventions delivered by CAs for the treatment of headaches.
Objective
This study has 2 aims. The first aim was to develop and test a smartphone-based coaching intervention (BalanceUP) for people experiencing frequent headaches, delivered by a CA and designed to improve mental well-being using various behavior change techniques. The second aim was to evaluate the effectiveness of BalanceUP by comparing the intervention and waitlist control groups and assess the engagement and acceptance of participants using BalanceUP.
Methods
In an unblinded randomized controlled trial, adults with frequent headaches were recruited on the web and in collaboration with experts and allocated to either a CA intervention (BalanceUP) or a control condition. The effects of the treatment on changes in the primary outcome of the study, that is, mental well-being (as measured by the Patient Health Questionnaire Anxiety and Depression Scale), and secondary outcomes (eg, psychosomatic symptoms, stress, headache-related self-efficacy, intention to change behavior, presenteeism and absenteeism, and pain coping) were analyzed using linear mixed models and Cohen d. Primary and secondary outcomes were self-assessed before and after the intervention, and acceptance was assessed after the intervention. Engagement was measured during the intervention using self-reports and usage data.
Results
A total of 198 participants (mean age 38.7, SD 12.14 y; n=172, 86.9% women) participated in the study (intervention group: n=110; waitlist control group: n=88). After the intervention, the intention-to-treat analysis revealed evidence for improved well-being (treatment: β estimate=–3.28, 95% CI –5.07 to –1.48) with moderate between-group effects (Cohen d=–0.66, 95% CI –0.99 to –0.33) in favor of the intervention group. We also found evidence of reduced somatic symptoms, perceived stress, and absenteeism and presenteeism, as well as improved headache management self-efficacy, application of behavior change techniques, and pain coping skills, with effects ranging from medium to large (Cohen d=0.43-1.05). Overall, 64.8% (118/182) of the participants used coaching as intended by engaging throughout the coaching and completing the outro.
Conclusions
BalanceUP was well accepted, and the results suggest that coaching delivered by a CA can be effective in reducing the burden of people who experience headaches by improving their well-being.
Trial Registration
German Clinical Trials Register DRKS00017422; https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00017422
This column explores the challenges involved in providing psychotherapy through artificial intelligence. It reviews artificial intelligence’s capacity across schools of therapy to address relevant issues related to privacy, the use of technical interventions, and the therapeutic relationship.
Background
Depression is a common mental disorder. Detecting (sub)clinical depressive symptoms in adolescents at an early stage and offering a low-threshold early intervention can minimize the risk of serious and/or long-term depression. As such, a digital intervention can be a low-threshold preventive and early intervention. This study aims to examine whether the Boost My Mood (BMM)-app is a suitable preventive early intervention for adolescents with (sub)clinical depressive symptoms.
Methods
This naturalistic single-arm evaluation study (N = 50) was conducted in adolescents aged 16–21 with (sub)clinical depressive symptoms. Furthermore, the BMM-app was studied in relation to anxiety, worrying, stress, and sleeping problems. An exploratory objective was to determine whether positive expectations and social support are related to app use.
Results
The study showed a significant decrease in not only depressive symptoms, but also anxiety, worrying and stress while using the BMM-app. Sleeping problems did not significantly decrease over time while using the BMM-app. The degree of use of the BMM-app and telling significant others about using the BMM-app were both not related to a decrease in depressive symptoms. The BMM-app was used significantly more when the adolescent had told relatives about their depressive symptoms.
Conclusions
A digital intervention, such as the BMM-app, can be a low-threshold preventive and early intervention for adolescents with (sub)clinical depressive symptoms. Beneficial effects of the BMM-app were reported on depressive symptoms as well as other aspects of quality of life, such as anxiety, worrying, and stress. Whereas several factors may have played a role in the current findings on depressive symptoms, there are reasons to assume that part of the reduction in symptoms could be attributed to the BMM-app. Although no causality can be assumed, this study is a first step in the implementation of preventive apps in mental health care.
This book sheds light on the translation of current mechanistic research on placebo effects to develop comprehensive and adequate strategies for better symptom management and treatment. This book identifies three core aspects to bridge state-of-the-art concepts with day-to-day clinical practice. First, lessons from mechanistic placebo research indicate a neurobiological basis underlying placebo effects. Second, placebo research can improve the design of clinical trials to advance drug development. Third, placebo effects can be exploited in daily clinical practice to optimize patient-clinician communication and relationships and clinical outcomes. Together, these three core aspects provide a new perspective with which to appraise the implications of Placebo Research for healthcare systems, clinicians, patients, and caregivers. New patient-centered approaches, mental health, and pain-related issues are discussed while describing technologically advanced and novel research applications that will shift current clinical practice to improve treatment outcomes.
Background
Repetitive negative thinking (RNT) is a key transdiagnostic mechanism underpinning depression and anxiety. Using “just-in-time adaptive interventions” via smartphones may disrupt RNT in real time, providing targeted and personalized intervention.
Objective
This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary clinical outcomes and mechanisms of Mello—a fully automated, personalized, transdiagnostic, and mechanistic smartphone intervention targeting RNT in young people with depression and anxiety.
Methods
Participants with heightened depression, anxiety, and RNT were recruited via social media and randomized to receive Mello or a nonactive control over a 6-week intervention period. Assessments were completed via Zoom sessions at baseline and at 3 and 6 weeks after baseline.
Results
The findings supported feasibility and acceptability, with high rates of recruitment (N=55), uptake (55/64, 86% of eligible participants), and retention (52/55, 95% at 6 weeks). Engagement was high, with 90% (26/29) and 59% (17/29) of the participants in the Mello condition still using the app during the third and sixth weeks, respectively. Greater reductions in depression (Cohen d=0.50), anxiety (Cohen d=0.61), and RNT (Cohen d=0.87) were observed for Mello users versus controls. Mediation analyses suggested that changes in depression and anxiety were accounted for by changes in RNT.
Conclusions
The results indicate that mechanistic, targeted, and real-time technology-based solutions may provide scalable and effective interventions that advance the treatment of youth mental ill health.
Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN12621001701819; http://tinyurl.com/4d3jfj9f
Background
Mindfulness-based mobile apps have become popular tools for enhancing well-being in today’s fast-paced world. Their ability to reduce geographical, financial, and social barriers makes them a promising alternative to traditional interventions.
Objective
As most available apps lack a theoretical framework, this review aimed to evaluate their effectiveness and assess their quality. We expected to find small sample sizes, high dropout rates, and small effect sizes in the included studies.
MethodsA systematic literature search was conducted using PsycInfo, PsycNet, PubMed, an institutional search engine (u:search), and Google Scholar. Randomized controlled trials assessing the impact of mobile mindfulness apps on well-being in nonclinical samples were included. Study selection, risk of bias (using the version 2 of the Cochrane risk-of-bias tool for randomized trials), and reporting quality (using selected CONSORT [Consolidated Standards of Reporting Trials] statement criteria) assessments were performed by 2 authors independently and discussed until a consensus was reached.
ResultsThe 28 included randomized controlled trials differed in well-being measures, apps, and intervention duration (7 to 56 days; median duration 28 days). A wide range of sample sizes (12 to 2282; median 161) and attrition rates (0% to 84.7%; median rate 23.4%) were observed. Most studies (19/28, 68%) reported positive effects on at least one aspect of well-being. The effects were presented using different metrics but were primarily small or small to medium in size. Overall risk of bias was mostly high.
Conclusions
The wide range of sample sizes, attrition rates, and intervention periods and the variation in well-being measures and mobile apps contributed to the limited comparability of the studies. Although most studies (16/28, 57%) reported small or small to medium effects for at least one well-being outcome, this review demonstrates that the generalizability of the results is limited. Further research is needed to obtain more consistent conclusions regarding the impact of mindfulness-based mobile apps on well-being in nonclinical populations.
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.
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.
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.
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.
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.
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.
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
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.
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.
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).
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.
Cubism was an influential early-20th-century art movement characterized by angular, disjointed imagery. The two-dimensional appearance of Cubist figures and objects is created through juxtaposition of angles. The authors posit that the constrained perspectives found in Cubism may also be found in the clinical classification of brain disorders. Neurological disorders are often separated from psychiatric disorders as if they stemmed from different organ systems. Maintaining two isolated clinical disciplines fractionalizes the brain in the same way that Pablo Picasso fractionalized figures and objects in his Cubist art. This Neural Cubism perpetuates a clinical divide that does not reflect the scope and depth of neuroscience. All brain disorders are complex and multidimensional, with aberrant circuitry and resultant psychopharmacology manifesting as altered behavior, affect, mood, or cognition. Trainees should receive a multidimensional education based on modern neuroscience, not a partial education based on clinical precedent. The authors briefly outline the rationale for increasing the integration of neurology and psychiatry and discuss a nested model with which clinical neuroscientists (neurologists and psychiatrists) can approach and treat brain disorders.
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.
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.
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.
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.
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
- Research Center
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pewinternet.org/fact-sheets/mobile-technology-fact-sheet/
(accessed Nov 1, 2015).
Smartphone apps for schizophrenia: a systematic review: e102. 3 IMS Institute Reports. Patient adoption of mHealth
- J Firth
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