Article

Usability, Acceptability, and Adherence to an Electronic Self-Monitoring System in Patients With Major Depression Discharged From Inpatient Wards

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Background Patients suffering from depression have a high risk of relapse and readmission in the weeks following discharge from inpatient wards. Electronic self-monitoring systems that offer patient-communication features are now available to offer daily support to patients, but the usability, acceptability, and adherence to these systems has only been sparsely investigated. Objective We aim to test the usability, acceptability, adherence, and clinical outcome of a newly developed computer-based electronic self-assessment system (the Daybuilder system) in patients suffering from depression, in the period from discharge until commencing outpatient treatment in the Intensive Outpatient Unit for Affective Disorders. Methods Patients suffering from unipolar major depression that were referred from inpatient wards to an intensive outpatient unit were included in this study before their discharge, and were followed for four weeks. User satisfaction was assessed using semiqualitative questionnaires and the System Usability Scale (SUS). Patients were interviewed at baseline and at endpoint with the Hamilton depression rating scale (HAM-D17), the Major Depression Inventory (MDI), and the 5-item World Health Organization Well-Being Index (WHO-5). In this four-week period patients used the Daybuilder system to self-monitor mood, sleep, activity, and medication adherence on a daily basis. The system displayed a graphical representation of the data that was simultaneously displayed to patients and clinicians. Patients were phoned weekly to discuss their data entries. The primary outcomes were usability, acceptability, and adherence to the system. The secondary outcomes were changes in: the electronically self-assessed mood, sleep, and activity scores; and scores from the HAM-D17, MDI, and WHO-5 scales. Results In total, 76% of enrolled patients (34/45) completed the four-week study. Five patients were readmitted due to relapse. The 34 patients that completed the study entered data for mood on 93.8% of the days (872/930), sleep on 89.8% of the days (835/930), activity on 85.6% of the days (796/930), and medication on 88.0 % of the days (818/930). SUS scores were 86.2 (standard deviation [SD] 9.7) and 79% of the patients (27/34) found that the system lived up to their expectations. A significant improvement in depression severity was found on the HAM-D17 from 18.0 (SD 6.5) to 13.3 (SD 7.3; P<.01), on the MDI from 27.1 (SD 13.1) to 22.1 (SD 12.7; P=.006), and in quality of life on the WHO-5 from 31.3 (SD 22.9) to 43.4 (SD 22.1; P<.001) scales, but not on self-assessed mood (P=.08). Mood and sleep parameters were highly variable from day-to-day. Sleep-offset was significantly delayed from baseline, averaging 48 minutes (standard error 12 minutes; P<.001). Furthermore, when estimating delay of sleep-onset (with sleep quality included in the model) during the study period, this showed a significant negative effect on mood (P=.03) Conclusions The Daybuilder systems performed well technically, and patients were satisfied with the system and had high adherence to self-assessments. The dropout rate and the gradual delay in sleep emphasize the need for continued clinical support for these patients, especially when considering sleep guidance.

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... In the area of relapse prevention, 4 studies from Germany [14][15][16][17], 1 study from the Netherlands [18], 1 study from Denmark [19], and 1 from the United States [20] were identified (Multimedia Appendix 1). ...
... The study periods ranged from 4 weeks to 104 weeks (24 months). Four studies were financed by countries [14,17,18,20], and 2 studies were privately financed [16,19]. One study did not provide information on financing [15]. ...
... Kraft et al [14] opted for a mindfulness-based exercise in which patients received feedback on the success via SMS. Lauritsen et al [19] used a web-based self-assessment tool that monitored participant mood, sleep, and activity, and Zwerenz et al [17] used a web-based self-help program based on CBT. One study did not provide any information on the chosen therapeutic approach [15]. ...
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Background: Depression is a major cause for disability worldwide, and digital health interventions are expected to be an augmentative and effective treatment. According to the fast-growing field of information and communication technologies and its dissemination, there is a need for mapping the technological landscape and its benefits for users. Objective: The purpose of this scoping review was to give an overview of the digital health interventions used for depression. The main goal of this review was to provide a comprehensive review of the system landscape and its technological state and functions, as well as its evidence and benefits for users. Methods: Ascopingreviewwasconductedtoprovideacomprehensiveoverviewofthefieldofdigitalhealthinterventionsfor the treatment of depression. PubMed, PSYNDEX, and the Cochrane Library were searched by two independent researchers in October 2020 to identify relevant publications of the last 10 years, which were examined using the inclusion and exclusion criteria. To conduct the review, we used Rayyan, a freely available web tool. Results: In total, 65 studies were included in the qualitative synthesis. After categorizing the studies into the areas of prevention, early detection, therapy, and relapse prevention, we found dominant numbers of studies in the area of therapy (n=52). There was only one study for prevention, 5 studies for early detection, and 7 studies for relapse prevention. The most dominant therapy approaches were cognitive behavioral therapy, acceptance and commitment therapy, and problem-solving therapy. Most of the studies revealed significant effects of digital health interventions when cognitive behavioral therapy was applied. Cognitive behavioral therapy as the most dominant form was often provided through web-based systems. Combined interventions consisting of web-based and smartphone-based approaches are increasingly found. Conclusions: Digital health interventions for treating depression are quite comprehensive. There are different interventions focusing on different fields of care. While most interventions can be beneficial to achieve a better depression treatment, it can be difficult to determine which approaches are suitable. Cognitive behavioral therapy through digital health interventions has shown good effects in the treatment of depression, but treatment for depression still stays very individualistic.
... Nine articles [5,28,[33][34][35][36][37][38][39] met the inclusion criteria for this systematic review. Mood monitoring studies were conducted in Chile [35], Denmark [33,34], South Africa [5,28], and the United States of America [36][37][38][39]. ...
... Nine articles [5,28,[33][34][35][36][37][38][39] met the inclusion criteria for this systematic review. Mood monitoring studies were conducted in Chile [35], Denmark [33,34], South Africa [5,28], and the United States of America [36][37][38][39]. Details regarding study designs and monitoring procedures are presented in Table 1. ...
... Details regarding study designs and monitoring procedures are presented in Table 1. Most studies used quantitative methods [5,[35][36][37][38][39][40], with only two studies [28,34] including a qualitative component (semi-structured interviews). Details regarding outcome measures, effectiveness, adverse events, and completion rates are presented in Table 2. Information regarding Population, Intervention, Comparison, Outcome, and Time (PICOT) is embedded in both Table 1 (P, I, C, T) and Table 2 (C, O). ...
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Background Broadening our knowledge of the longitudinal course of mood symptoms is cardinal to providing effective long-term treatments. Research indicates that patients with mental illness are willing to engage in the use of telemonitoring and mobile technology to assess and monitor their mood states. However, without the provision of distant support, adverse outcomes and events may be difficult to prevent and manage through self-monitoring. Understanding patient perspectives is important to achieving the best balance of self-monitoring, patient empowerment, and distant supporter involvement. Methods This systematic review synthesises quantitative and qualitative evidence of the effectiveness and feasibility of daily/weekly/monthly remote mood monitoring that includes distant support in participants with mood disorders. Inclusion criteria comprised mood monitoring of mood disorder patients as main intervention, study design, method of monitoring, and presence of psychotherapy and psychoeducation. Effectiveness was defined by the change in depression and/or mania scores. Feasibility was determined on participant feedback and completion/attrition rates. Studies were assessed for quality using the Mixed Methods Appraisal Tool version 2018. Results Nine studies of acceptable quality met the inclusion criteria. Distant mood monitoring was effective in improving depression scores but not mania scores. Feasibility, as measured through compliance and completion rates and participant feedback, varied. Conclusion Distant mood monitoring with support may be a useful, acceptable, and feasible intervention for diverse groups of patients in terms of age and ethnicity. Further, it may be effective in improving symptoms of depression, increasing treatment adherence, and facilitating the prevention and management of adverse outcomes. As a task-shifting intervention, distant mood monitoring may help to alleviate the burden on mental health providers in developing countries.
... Patient Self-Report By far the most commonly studied (n = 54) method for measuring medication adherence was patient self-report. Many multi-component apps or websites included daily or weekly surveys filled out by the participants; self-report of medication adherence was frequently included in these surveys [42][43][44][45][46][47][48]; interactive voice response (IVR), telephone, text messaging, and videoconferencing interventions similarly included questions evaluating medication adherence [49][50][51][52][53][54][55]. Furthermore, self-report was frequently used as a baseline adherence assessment method to which other, more 'objective' measures were compared [56][57][58][59]. ...
... Frequently, this was one part of multi-component interventions, but some studies evaluated the effect of feedback alone as an adherence-enhancing intervention [84,85,89,103,104]. Other systems included feedback on more than just adherence data (e.g., symptomatic progression as assessed by self-report) [44,46,122]. Note that accurate medication adherence feedback rests on the assumption of an accurate measurement method. ...
... The data given to the clinician was sourced from many of the previously listed medication measurement components (direct visualization, smart pill dispenser, selfreport, etc). Multiple studies (n = 31) explicitly mentioned such systems [40,42,[44][45][46]49,51,53,63,65,92,94,96,105,106,108,109,113,114,116,118,[120][121][122]125,127,139,140,[146][147][148], which fell under three major categories (not mutually exclusive): "portal" real-time monitoring (n = 15), periodic reporting (n = 9), and alerts (n = 16). Real-time monitoring (B.5.2.1) allows the clinician to, at any time they chose, examine their participants' medication adherence data, almost always through web portals [40,[44][45][46]63,65,96,105,106,108,109,118,120,122,148]. ...
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Background Medication adherence is critical to the effectiveness of psychopharmacologic therapy. Psychiatric disorders present special adherence considerations, notably an altered capacity for decision making and the increased street value of controlled substances. A wide range of interventions designed to improve adherence in mental health and substance use disorders have been studied; recently, many have incorporated information technology (eg, mobile phone apps, electronic pill dispensers, and telehealth). Many intervention components have been studied across different disorders. Furthermore, many interventions incorporate multiple components, making it difficult to evaluate the effect of individual components in isolation. Objective The aim of this study was to conduct a systematic scoping review to develop a literature-driven, transdiagnostic taxonomic framework of technology-based medication adherence intervention and measurement components used in mental health and substance use disorders. Methods This review was conducted based on a published protocol (PROSPERO: CRD42018067902) in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses systematic review guidelines. We searched 7 electronic databases: MEDLINE, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials, Web of Science, Engineering Village, and ClinicalTrials.gov from January 2000 to September 2018. Overall, 2 reviewers independently conducted title and abstract screens, full-text screens, and data extraction. We included all studies that evaluate populations or individuals with a mental health or substance use disorder and contain at least 1 technology-delivered component (eg, website, mobile phone app, biosensor, or algorithm) designed to improve medication adherence or the measurement thereof. Given the wide variety of studied interventions, populations, and outcomes, we did not conduct a risk of bias assessment or quantitative meta-analysis. We developed a taxonomic framework for intervention classification and applied it to multicomponent interventions across mental health disorders. Results The initial search identified 21,749 results; after screening, 127 included studies remained (Cohen kappa: 0.8, 95% CI 0.72-0.87). Major intervention component categories include reminders, support messages, social support engagement, care team contact capabilities, data feedback, psychoeducation, adherence-based psychotherapy, remote care delivery, secure medication storage, and contingency management. Adherence measurement components include self-reports, remote direct visualization, fully automated computer vision algorithms, biosensors, smart pill bottles, ingestible sensors, pill counts, and utilization measures. Intervention modalities include short messaging service, mobile phone apps, websites, and interactive voice response. We provide graphical representations of intervention component categories and an element-wise breakdown of multicomponent interventions. Conclusions Many technology-based medication adherence and monitoring interventions have been studied across psychiatric disease contexts. Interventions that are useful in one psychiatric disorder may be useful in other disorders, and further research is necessary to elucidate the specific effects of individual intervention components. Our framework is directly developed from the substance use disorder and mental health treatment literature and allows for transdiagnostic comparisons and an organized conceptual mapping of interventions.
... The most severely depressed patients are admitted to psychiatric inpatient wards. Even though patients improve substantially during their stay they are usually still not fully recovered when discharged [5,6], leaving them at risk of depression worsening, and consequent readmission [7][8][9]. The suicidal risk in recently discharged patients with MDD has also been found to be markedly increased [10]. ...
... In our previous feasibility study, we developed an electronic monitoring system Daybuilder (now Monsenso Daybuilder = MDB) for use with patients suffering from MDD [6]. The system was found to be reliable and easy to use, even for patients recently treated with Electroconvulsive Treatment. ...
... Furthermore, daytime naps induce hour-long mood drops in a large proportion of depressed patients [46]. Our usability study, using electronic monitoring that documented sleep patterns over a four-week period in patients recently discharged from a mental health hospital, found a day-to-day highly variable sleep-wake cycle with gradually delayed sleep and unstable mood [6]. ...
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Background The transition phase from inpatient to outpatient care for patients suffering from Major Depressive Disorder represents a vulnerable period associated with a risk of depression worsening and suicide. Our group has recently found that the sleep-wake cycle in discharged depressive patients became irregular and exhibited a drift towards later hours, associated with worsening of depression. In contrast, an advancement of sleep phase has earlier been shown to have an antidepressant effect. Thus, methods to prevent drift of the sleep-wake cycle may be promising interventions to prevent or reduce worsening of depression after discharge. Methods In this trial, we apply a new treatment intervention, named Circadian Reinforcement Therapy (CRT), to patients discharged from inpatient psychiatric wards. CRT consists of a specialized psychoeducation on the use of regular time signals (zeitgebers): daylight exposure, exercise, meals, and social contact. The aim is to supply stronger and correctly timed zeitgebers to the circadian system to prevent sleep drift and worsening of depression. The CRT is used in combination with an electronic self-monitoring system, the Monsenso Daybuilder System (MDB). By use of the MDB system, all patients self-monitor their sleep, depression level, and activity (from a Fitbit bracelet) daily. Participants can inspect all their data graphically on the MDB interface and will have clinician contact. The aim is to motivate patients to keep a stable sleep-wake cycle. In all, 130 patients referred to an outpatient service will be included. Depression rating is blinded. Patients will be randomized 1:1 to a Standard group or a CRT group. The intervention period is 4 weeks covering the transition phase from inpatient to outpatient care. The primary outcome is score change in interviewer rated levels of depression on the Hamilton Depression Rating Scale. A subset of patients will be assessed with salivary Dim Light Melatonin Onset (DLMO) as a validator of circadian timing. The trial was initiated in 2016 and will end in 2020. Discussion If the described intervention is beneficial it could be incorporated into usual care algorithms for depressed patients to facilitate a better and safer transition to outpatient treatment. Trial registration Posted prospectively at ClinicalTrials.gov at February 10, 2016 with identifier NCT02679768.
... In relation to NA, 13 of 15 identified studies found evidence to support a significant inverse relationship between self-reported sleep quality and next day NA in a range of populations including children and adolescents (23, 25,36), women (44,48), older adults (27), participants with depression (28,29), and PI (30). ...
... Poorer sleep quality was also associated with higher NA in subjects with major depressive disorder (28,29). This relationship was found to be independent of depression status, gender, chronotype, and use of psychotropic medication (28). ...
Article
An intimate relationship exists between sleep and affective states. Disturbances in sleep are common across a spectrum of psychopathologies, and are recognised as precipitating or prodromal factors for mood disorders. Conversely, affective states can impact sleep quality and ability to fall asleep. However, one of the main limitations of this literature is that studies have typically assessed sleep and mood at one time point and studies are often laboratory-based, where measurement of both sleep and mood has dubious ecological validity. The aim of the current review was to systematically examine the evidence for associations between day-to-day fluctuations in sleep and mood in naturalistic studies using ambulatory diary techniques. Electronic databases (EMBASE, PsycINFO, PubMed, and SCOPUS) were searched for studies using experience sampling methodology to investigate daily associations between sleep and mood in naturalistic environments in healthy and clinical samples. Findings of the included studies supported the notion of a reciprocal relationship between subjective sleep variables (sleep quality, sleep duration and sleep latency) and daytime affective states over the short term, and highlight the potential clinical importance of daily sleep disturbance in the prediction and prevention of the development of psychopathology in the future.
... Self-monitoring is a highly utilized treatment component across EBTs. The potential benefits of self-monitoring with digital devices are face valid but have also been demonstrated in a range of treatment modalities [20], with recent findings indicating positive usability and clinical effects in diverse settings, from the treatment of eating disorders [21] to the provision of support for those with serious mental illness transitioning from inpatient services [22]. Current developments point to the increased use and benefits of selfmonitoring when combined with asynchronous telehealth strategies, which enable automatic sharing of self-tracked data with therapists, to increase support, coaching, teamwork, or accountability [23]. ...
... Measuring and attaining adequate usability on standardized instruments in mental health technology development is becoming more common. For example, recent examinations of treatments for depression using self-monitoring [22], inperson and on-line group intervention [115], and a mobile app with email support [116] have reported laudable SUS scores of between 80 and 86. Yet we note that just as there is a difference between treatment efficacy in controlled trials and treatment effectiveness in disseminated settings, we cannot assume usability ratings in product development research will necessarily convey during implementation. ...
Article
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Purpose of Review We provide a critical review of digital technologies in evidence-based treatments (EBTs) for mental health with a focus on the functions technologies are intended to serve. The review highlights issues related to clarity of purpose, usability, and assumptions related to EBT technology integration, branding, and packaging. Recent Findings Developers continue to use technology in creative ways, often combining multiple functions to convey existing EBTs or to create new technology-enabled EBTs. Developers have a strong preference for creating and investigating whole-source, branded solutions related to specific EBTs, in comparison to developing or investigating technology tools related to specific components of behavior change, or developing specific clinical protocols that can be delivered via existing technologies. Summary Default assumptions that new applications are required for each individual EBT, that EBTs are best served by the use of only one technology solution rather than multiple tools, and that an EBT-specific technology product should include or convey all portions of an EBT slow scientific progress and increase risk of usability issues that negatively impact uptake. We contend that a purposeful, functions-based approach should guide the selection, development, and application of technology in support of EBT delivery.
... This effect is mediated through the suprachiasmatic nuclei in the hypothalamus and the pineal gland where light suppresses melatonin production [11] . Phase advance of the sleep-wake cycle has been found to have an antidepressant effect in patients with major depression [12,13] and, conversely, sleep delays have been found to be depressogenic [14] . ...
... Robillard et al. [16] found that young patients with bipolar and unipolar depression were sleep-delayed compared to normal values in the population. Furthermore, we were able to confirm that depressed patients tend to drift to a later sleep schedule when discharged from inpatient wards [14] . Thus, timed lighting with appropriate intensity and spectral distribution should be able to entrain and advance a drifted sleep-wake cycle in patients with depression and thereby improve their condition. ...
Article
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Background and aim: Improvement in patients admitted to inpatient wards with severe depression is slow, and such patients are often discharged with residual symptoms which put them at risk for relapse. New treatments that can speed up recovery are highly desired. This naturalistic follow-up study in a specialized affective disorders unit investigated the impact of daylight on the length of hospital stay and improvement of depression. Methods: For a period of 1 year, we collected data on sociodemographics, length of stay, vitamin D, and depression severity for patients in an inpatient affective disorders unit. The ward is located with one facade that faces southeast (SE); the opposite one faces northwest (NW) and receives far less light and no direct sunlight during winter. Results: SE-facing rooms received far more daylight than NW-facing rooms. The length of stay was significantly lower in the SE rooms, i.e., 29.2 (±26.8) versus 58.8 (±42.0) days in the NW rooms (p = 0.01). There was a statistically nonsignificant greater reduction of 52.2% in depression severity for the patients staying in the SE rooms compared to 42.2% in the NW rooms, which may nevertheless be clinically relevant. Conclusion: Due to the study design, no causality for the observed difference in length of stay can be given, but the results support findings in previous studies of the importance of architectural orientation providing natural daylight as a factor for improvement.
... There are many apps for depression integrating a self-monitoring feature and several studies have examined their usability, acceptability, adherence and effectiveness. Self-monitoring of depressive symptoms on patients' phones has been shown to be easy and reliable [51,52] and several studies highlighted its effectiveness to improve depressive symptoms [36,53,54]. A study on untreated patients with symptoms of depression and anxiety also showed that access to daily self-monitoring helped them to translate their intention to seek treatment into actual treatment-seeking behaviour [55]. ...
... However, the main bottleneck of self-monitoring is the low retention rate of apps offering this feature. For this particular point, studies showed inconsistent results, where some highlighted a quick drop out rate of self-monitoring apps [56,57], while others noted, conversely, a fairly high retention rate for these tools [52,54,58]. ...
Article
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Background Despite an increasing number of smartphone apps, such therapeutic tools have not yet consistently demonstrated their efficacy and many suffer from low retention rates. To ensure the development of efficient apps associated with high adherence, we aimed to identify, through a user-centred design approach, patient and physician expectations of a hypothetical app dedicated to depression. Methods We conducted semi-structured interviews with physicians (psychiatrists and general practitioners) and patients who had experienced a major depressive episode during the last 12 months using the focus group method. The interviews were audio recorded, transcribed and analysed using qualitative content analysis to define codes, categories and emergent themes. Results A total of 26 physicians and 24 patients were included in the study. The focus groups showed balanced sex and age distributions. Most participants owned a smartphone (83.3% of patients, 96.1% of physicians) and were app users (79.2% of patients and 96.1% of physicians). The qualitative content analysis revealed 3 main themes: content, operating characteristics and barriers to the use of the app. Expected content included the data collected by the app, aiming to provide information about the patient, data provided by the app, gathering psychoeducation elements, therapeutic tools and functionalities to help with the management of daily life and features expected for this tool. The “operating characteristics” theme gathered aims considered for the app, its potential target users, considered modalities of use and considerations around its accessibility and security of use. Finally, barriers to the use of the app included concerns about potential app users, its accessibility, safety, side-effects, utility and functioning. All themes and categories were the same for patients and physicians. Conclusions Physician and patient expectations of a hypothetical smartphone app dedicated to depression are high and confirmed the important role it could play in depression care. The key points expected by the users for such a tool are an easy and intuitive use and a personalised content. They are also waiting for an app that gives information about depression, offers a self-monitoring functionality and helps them in case of emergency.
... 27 Furthermore, patients with depression are prone to drift to later sleep schedules. 3 We should thus expect that dynamic lighting with enriched short-wavelength morning light and low content shortwavelength light in the evening would prevent drifting or even phase advance the sleep-wake cycle and thus augment the antidepressant treatment response. 28 Since the publication of the first study on the effect of light therapy for depression by Rosenthal et al in 1984, 12 a large number of studies have been carried out to investigate the efficacy of BLT on both seasonal and non-seasonal depression. ...
Article
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Introduction Retrospective studies conducted in psychiatric inpatient wards have shown a relation between the intensity of daylight in patient rooms and the length of stay, pointing to an antidepressant effect of ambient lighting conditions. Light therapy has shown a promising antidepressant effect when administered from a light box. The emergence of light-emitting diode (LED) technology has made it possible to build luminaires into rooms and to dynamically mimic the spectral and temporal distribution of daylight. The objective of this study is to investigate the antidepressant efficacy of a newly developed dynamic LED-lighting system installed in an inpatient ward. Methods and analysis In all, 150 inpatients with a major depressive episode, as part of either a major depressive disorder or as part of a bipolar disorder, will be included. The design is a two-arm 1:1 randomised study with a dynamic LED-lighting arm and a static LED-lighting arm, both as add-on to usual treatment in an inpatient psychiatric ward. The primary outcome is the baseline adjusted score on the 6-item Hamilton Depression Rating Scale at week 3. The secondary outcomes are the mean score on the Suicidal Ideation Attributes Scale at week 3, the mean score on the 17-item Hamilton Depression Rating Scale at week 3 and the mean score on the World Health Organisation Quality of Life-BREF (WHOQOL-BREF) at week 3. The spectral distribution of daylight and LED-light, with a specific focus on light mediated through the intrinsically photosensitive retinal ganglion cells, will be measured. Use of light luminaires will be logged. Assessors of Hamilton Depression Rating Scale scores and data analysts will be blinded for treatment allocation. The study was initiated in May 2019 and will end in December 2021. Ethics and dissemination No ethical issues are expected. Results will be published in peer-reviewed journals, disseminated electronically and in print and presented at symposia. Trial registration number NCT03821506; Pre-results .
... The treatment of patients with severe depression, whether as part of a unipolar or bipolar disorder, still lacks efficacy. Patients are often discharged with residual depressive symptoms [1] making them at risk of relapse [2]. There has been no recent breakthrough in psychopharmacology or psychotherapy, and new methods are therefore needed. ...
Article
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Background: Retrospective studies conducted in psychiatric wards have indicated a shorter duration of stay for depressed inpatients in bright compared to dim daylight-exposed rooms, pointing to a possible antidepressant effect of daylight conditions. Dynamic LED lighting, aiming to mimic daylight conditions, are currently been installed in several hospitals, but their feasibility is poorly investigated. Methods: To investigate the feasibility of these systems, we developed and installed a LED-lighting system in four rooms in a psychiatric inpatient ward. The system could function statically or dynamically regarding light intensity and colour temperature. The system consisted of (A) a large LED luminaire built into the window jamb mimicking sunlight reflections, (B) two LED light luminaires in the ceiling and (C) a LED reading luminaire. In the static mode, the systems provided constant light from A and B. In the dynamic mode, the system changed light intensity and colour temperature using A, B and C. Patients with unipolar or bipolar depression were randomised to dynamic or static LED lighting for 4 weeks, in addition to standard treatment. Primary outcome was the rate of patients discontinuing the trial due to discomfort from the lighting condition. Secondary outcomes were recruitment and dropout rates, visual comfort, depressive symptoms and suicidal ideation. Results: No participants discontinued due to discomfort from the LED lighting. Recruitment rate was 39.8%, dropout from treatment rates were 56.3% in the dynamic group and 33.3% in the static group. 78.1% in the dynamic group were satisfied with the lighting compared with 71.8% in the static group. Discomfort from the light (glare) was reported by 11.5% in the dynamic group compared to 5.1% in the static group. Endpoint suicidal scores were 16.8 (10.4) in the dynamic and 16.3 (14.9) in the static group. The lighting system was 100% functional. The light sensor system proved unstable. Conclusion: Dropout from treatment was high primarily due to early discharge and with a lack of endpoint assessments. The feasibility study has influenced an upcoming large-scale dynamic lighting efficacy trial where we will use a shorter study period of 3 weeks and with more emphasis on endpoint assessments. The lighting was well tolerated in both groups, but some found intensity too low in the evening. Thus, we will use higher intensity blue-enriched light in the morning and higher intensity amber (blue-depleted) light in the evening in the upcoming study. The light sensor system needs to be improved. Trial registration: ClinicalTrials.gov: NCT03363529.
... In all, 17 studies used written reminders such as email, SMS or push notifications. 21,26,27,[29][30][31][32][33]39,42,44,49,54,55,60,65,69 Two studies used telephone reminders, and one reminded people when they arrived at the clinic. 48 Nonparticipation and dropout rates. ...
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Data from digitally administered patient reported outcomes (PROs) is used more and more in routine healthcare for long-term conditions as a part of daily clinical practice. This literature study reviews empirical studies of digital PRO to examine patients’ reasons for non-use of digitally administered PRO data in routine care. This scoping review searched through PubMed, Embase, Web of Science and PsycINFO databases, reporting on study population, intervention, duration of intervention and motivational factors alongside stated reasons for nonparticipation or dropout for each study. The patients’ reasons for not participating, either from study start or by dropout, were analysed through a thematic approach. Fifty-one studies were included, published from 2010 to 2019, mostly from Europe and the Unites States covering different long-term conditions. The reasons for non-use are manifold and cover the themes of ability to use PRO, engagement, emotional distress and technical barriers. Several reasons are given explaining why patients with long-term conditions are not using digitally administered PRO as intended. This should be taken into account in the design phase of digital PRO interventions and considered in conversations with patients during the intervention.
... The maximum score for the MSM is 15, and the score is categorized into mild: 3-6, moderate: 7-10, and severe 11-15 (26). Usability was assessed by the System Usability Scale (SUS) (27). The participants were evaluated for inclusion/exclusion criteria and provided an informed consent before being enrolled in the study. ...
Article
Background: Major depression (MD) contributes significantly to the global burden of disease with up to one-third of patients being treatment resistant. Therefore, the development of new treatment options for treatment-resistant depression (TRD) is needed. Vagus nerve stimulation (VNS) has shown mood improvements in patients with TRD. However, due to high costs related to the implantation and the invasive nature of VNS, an application with transcutaneous VNS (t-VNS) has been developed stimulating a vagal nerve branch in the earlobe (Arnold's nerve). A few studies with t-VNS in MD has shown a possible antidepressant effect, but feasibility is poorly described and patients with TRD have not been investigated. Objectives: As the full antidepressant effect of t-VNS takes months we wanted to assess feasibility and side effects of daily treatments. Materials and methods: Single-arm feasibility trial assessing compliance, usability, side effects, cognitive speed, and depression in a four-week period with a recommended t-VNS stimulation duration of four hours per day in patients with TRD. The primary outcome was compliance with 80% of the recommended daily treatment time. Results: Compliance threshold was reached for 80.0% of the 20 included participants. Usability was acceptable. Side effects were few, mild or moderate, mostly as local effects at the contact point in the ear. The device was difficult to use for some participants. A statistically significant reduction in depression severity and an increase in cognitive speed were seen with unchanged suicidal ideation and sleep. Conclusions: We would recommend larger long-term randomized studies of t-VNS to access any antidepressant effect in TRD. The design of the device might be improved for higher usability.
... Previous research has lacked investigation into the impact of clinical status on MHapp use outcomes (Dubad et al., 2017). Studies that have used nonclinical samples, with a normal distribution of mental health status, have generally found small to no effects of MHapp use (Bidargaddi et al., 2017;Howells et al., 2014;Whittaker et al., 2017), whereas studies that used clinical samples, with participants who were experiencing a diagnosable disorder, have found much stronger effects (Kauer et al., 2012;Lauritsen et al., 2017). Baseline clinical status is therefore an important factor to take into account when examining MHapp engagement as certain benefits may be limited to people experiencing depression or anxiety (Dubad et al., 2017). ...
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Objective There is an abundance of evidence supporting the efficacy of computerised cognitive behavioural therapy (CBT), but few studies have evaluated mobile applications (apps) that provide CBT strategies. This study investigating the relationships between mental health outcomes and engagement with a mobile app that recommended short CBT strategies. Method Participants downloaded the MoodMission app from the iOS and Android app stores, completed in‐app baseline assessments, and final assessments 30 days later. Participants reported their mood to MoodMission when they were feeling low or anxious and received a list of short CBT strategies to choose from and engage in. Data from 617 assessment completers (71% female; M age = 27 years) were analysed via hierarchical and mediated regressions. Results App engagement ratings predicted increases in mental wellbeing. Mediation analyses revealed that there were indirect effects of app engagement on depression, anxiety, and mental wellbeing via the mediator of coping self‐efficacy. Subsample analyses found this only for participants who were experiencing a moderate level of depression or anxiety at the time of the baseline assessment. Conclusions Engaging with an app that provides CBT strategies can increase mental wellbeing, and coping self‐efficacy may mediate effects of the app in individuals experiencing moderate depression or anxiety.
... 8,9,31 Yet a few other studies have shown that actigraphy-determined sleep efficiency and total sleep time seem to be associated with higher next-day positive affect, 7,10 and lower sleep onset latency is associated with higher positive affect and lower next-day negative affect. 7,8,32 The utility of single-channel electroencephalography ...
Article
Objective/Background Disrupted sleep can be a cause and a consequence of affective experiences. However, daily longitudinal studies show sleep assessed via sleep diaries is more consistently associated with positive and negative affect than sleep assessed via actigraphy. The objective of the study was to test whether sleep parameters derived from ambulatory electroencephalography (EEG) in a naturalistic setting were associated with day-to-day changes in affect. Participants/Method Eighty adults (mean age = 32.65 years, 63% female) completed 7 days of affect and sleep assessments. We examined bidirectional associations between morning positive affect and negative affect with sleep assessed via diary, actigraphy, and ambulatory EEG. Results Mornings with lower positive affect than average were associated with higher diary- and actigraphy-determined sleep efficiency that night. Mornings with higher negative affect than average were associated with longer actigraphy-determined total sleep time that night. Nights with longer diary-determined total sleep time, greater sleep efficiency, and shorter sleep onset latency than average were associated with higher next-morning positive affect, and nights with lower diary-determined wake-after-sleep-onset were associated with lower next-morning negative affect. EEG-determined sleep and affect results were generally null in both directions: only higher morning negative affect was associated with longer rapid eye movement (REM) sleep that night. Conclusions Self-reported sleep and affect may occur in a bidirectional fashion for some sleep parameters. EEG-determined sleep and affect associations were inconsistent but may still be important to assess in future studies to holistically capture sleep. Single-channel EEG represents a novel, ecologically valid tool that may provide information beyond diaries and actigraphy.
... Vi har således i et studie med brug af elektronisk monitorering hos pa tienter umiddelbart efter udskrivelse fundet, at patien terne gradvist udviklede en senere søvnstart. Jo mere nattesøvnen forskød sig til senere på døgnet, jo svaerere blev depressionsgraden [26]. Systematisk psykoeduka tion til at imødegå denne forskydning af søvnen og for vaerring af depressionen undersøges i et igangvaerende projekt. ...
Article
Circadian and seasonal rhythm disturbances are prominent in patients with psychiatric disorders. Properly timed and dosed light of specific spectral composition stabilises mood and sleep through serotonergic mechanisms and through input to the master circadian clock in the hypothalamus. Correctly administered, light can be used as an effective treatment for seasonal and non-seasonal depression and for stabilising the sleep-wake cycle. Blocking blue light in the evening may provide a non-pharmacological anti-manic tool. Current developments use dynamic lighting built into somatic and psychiatric hospitals to maximise the beneficial effects of light.
... Mobile technology is integrated into the daily life of users differently to that of the computer; for example, it often has touchscreen, smaller screens, and is used frequently throughout the 24-hour period. The need to be able to access the programme from a mobile device is explicitly mentioned in several of the examined articles (Kok, 2014, Lauritsen et al. 2017Miloff et al. 2015;Pham et al. 2016;Wilansky et al. 2016;Zhao et al. 2017). ...
Article
ABSTRACT: Computer scientists contend that understanding human computer interaction (HCI) is an important factor in developing successful computer user experiences. Mental health professionals across a range of disciplines are increasingly developing and implementing Internet-based treatments for people with a variety of mental health conditions. Many therapeutic and economic benefits are associated with technology-enabled treatments for a range of mental health disorders. Despite this, the role of HCI and associated design elements remains poorly understood in regard to the impact on patient safety, effectiveness, and to adherence of treatment for computer users who engage with e-mental health interventions. An integrative literature review was conducted to investigate how adequately HCI and user-centred design is incorporated in the development of e-mental health interventions for depression and anxiety, and subsequently reported in literature to inform evidence-based practice. The PRISMA model was used to locate, select, and include 30 relevant articles. The main finding of this review is that Internet-based e-mental health interventions are routinely implemented without sufficiently describing the relevant HCI design features applied. This is a limitation that in turn jeopardizes the assessment validity of e-mental interventions generally, leaving those who administer the interventions with incomplete evidence to support the safe, reliable, dependable, credible, and trustworthy implementation of the interventions. The recommendation arising from this review is that human computer interaction should be carefully considered when mental health nurses and other practitioners adopt e-mental health interventions for therapeutic purposes to assure the quality and safety of e-mental health interventions on offer to patients.KEY WORDS: anxiety, depression, digital interventions, e-mental health, patient safety.
... Since the publication of the WHO-5 in 1998, it has been translated into more than 30 languages, including Spanish, and it has been used in research studies all over the world in diverse fields, including endocrinology, oncology and psychiatry. In psychiatry, most studies have been conducted in patients with unipolar depressive disorder (Arnfred et al., 2017;Bonsignore et al., 2001;Christensen et al., 2015;Lauritsen et al., 2017;Möller Leimkühler et al., 2007). In non-clinical samples, it has been used as a screening tool for depression (Heun et al., 1999); however it has also been applied as an outcome measure in some clinical trials in patients with depressive disorder (Guico-Pabia et al., 2012;Martiny et al., 2012). ...
Article
Background: The concept of well-being which focuses on positive emotions has received increased research attention. However, a consensus definition of this term is lacking. The Well-Being Index scale (WHO-5) is a generic, self-report scale that contains five Likert-type items to evaluate psychological well-being. This construct may provide a relevant outcome in bipolar disorder (BD) research and care beyond the rating of mood symptoms. Thus, in the current study, the psychometric properties of the WHO-5 Spanish version were assessed in a sample of euthymic patients with BD. Methods: Patients with BD- I and BD-II and healthy controls completed the Well-Being Index (WHO-5) together with an assessment of depressive (Hamilton Depression Rating Scale-17; HAM-D) and manic symptoms (Young Mania Rating Scale; YMRS); and a measure of psychosocial functioning (Functioning Assessment Short Test; FAST). Internal consistency reliability was measured through Cronbach's alpha. Test-retest reliability was calculated comparing the WHO-5 total score at baseline and after 10 days of the first administration. To assess the structure of the scale, a principal component analysis (PCA) was carried out. Correlations between the WHO-5, HAM-D, YMRS and FAST were calculated. Finally, a t-test for independent samples was applied to compare the WHO-5 total score in the patient and control groups. Results: A total of 104 patients with BD and 40 healthy controls were included in this study. A Chronbach's alpha of 0.83 indicated acceptable internal consistency. A paired sample t-test revealed no significant differences between WHO-5 total score at baseline and at follow-up (tn = - 0.72; df = 15; p = 0.48). The PCA provided a single factor solution that accounted for 59.74% of the variation in WHO-5. Test-retest reliability was high (r = 0.83; p < 0.001). Moderate negative correlations were observed between the WHO-5 total score, the FAST (r = - 0.46.; p < 0.001) and the HAM-D (r = - 0.68; p < 0.001), but not with the YMRS (r = - 0.07; p = 0.42). Finally, significant differences were found when comparing the WHO-5 total score between patient and healthy controls (t = 5.1; df = 147; p < 0.001). Limitations: some limitations include the lack of a comparator scale to test for validity construct and the small sample size in the test-retest reliability CONCLUSIONS: The WHO-5 shows an acceptable reliability index and measures a unitary construct in a Spanish population of euthymic patients with BD.
... Previous research has lacked investigation into the impact of clinical status on MHapp use outcomes (Dubad et al., 2017). Studies that have used nonclinical samples, with a normal distribution of mental health status, have generally found small to no effects of MHapp use (Bidargaddi et al., 2017;Howells et al., 2014;Whittaker et al., 2017), whereas studies that used clinical samples, with participants who were experiencing a diagnosable disorder, have found much stronger effects (Kauer et al., 2012;Lauritsen et al., 2017). Baseline clinical status is therefore an important factor to take into account when examining MHapp engagement as certain benefits may be limited to people experiencing depression or anxiety (Dubad et al., 2017). ...
... Mobile technology is integrated into the daily life of users differently to that of the computer; for example, it often has touchscreen, smaller screens, and is used frequently throughout the 24-hour period. The need to be able to access the programme from a mobile device is explicitly mentioned in several of the examined articles (Kok, 2014, Lauritsen et al. 2017Miloff et al. 2015;Pham et al. 2016;Wilansky et al. 2016;Zhao et al. 2017). ...
Presentation
Aim: To identify the human computer interactions (HCI) recognized in International literature regarding E Mental Health interventions for people with depression and anxiety disorders. Mental health professionals are increasingly developing and including E Mental Health interventions in treatment plans. Implied therapeutic and economic benefits are frequently expounded to promote inclusion of these types of interventions. Yet, little attention has been given to the impact that design elements and HCI are likely to have on patient safety, effectiveness and with adherence to treatment. This represents a significant gap in the literature that may be a risk for the future safe and effective development of innovative E Mental Health Interventions. An integrative literature review was conducted to investigate how adequately HCI is incorporated in the development of E Mental Health interventions for depression and anxiety. The PRISMA model was used to discover, select and include relevant articles from suitable databases. The main outcome of this review is that HCI aspects are superficially described in literature about E Mental Health interventions, but insufficiently to scientifically validate design principles and HCI. This is an important limitation in most literature because it compromises the innovation and leaves those who manage and implement the interventions, such as mental health nurses and others, with incomplete evidence to support the safe, reliable, and evidence-driven implementation of the interventions. Research implication: E Mental Health researchers should consider the need to include computing science and HCI principles as a core element of research design to improve the quality and safety of interventions they trial or implement in the future. Mental health nursing implications: Mental health nurses should assess and consider the safety of incorporating E Mental Health interventions based on sound and robust evidence.
Article
Background: Patients with unipolar depressive disorder are frequently hospitalized, and the period following discharge is a high-risk-period. Smartphone-based treatments are receiving increasing attention among researchers, clinicians, and patients. We aimed to investigate whether a smartphone-based monitoring and treatment system reduces the rate and duration of readmissions, more than standard treatment, in patients with unipolar depressive disorder following hospitalization. Methods: We conducted a pragmatic, investigator-blinded, randomized controlled trial. The intervention group received a smartphone-based monitoring and treatment system in addition to standard treatment. The system allowed patients to self-monitor symptoms and access psycho-educative information and cognitive modules. The patients were allocated a study-nurse who, based on the monitoring data, guided and supported them. The control group received standard treatment. The trial lasted six months, with outcome assessments at 0, 3, and 6 months. Results: We included 120 patients with unipolar depressive disorder (ICD-10). Intention-to-treat analyses showed no statistically significant differences in time to readmission (Log-Rank p=0.9) or duration of readmissions (B=-16.41,95%CI:-47.32;25.5,p=0.3) (Primary outcomes). There were no differences in clinically rated depressive symptoms (p=0.6) or functioning (p=0.1) (secondary outcomes). The intervention group had higher levels of recovery (B=7,29, 95%CI:0.82;13,75,p=0.028) and a tendency towards higher quality of life (p= 0.07), wellbeing (p=0,09) satisfaction with treatment (p=0.05) and behavioral activation (p=0.08) compared with the control group (tertiary outcomes). Limitations: Patients and study-nurses were unblinded to allocation. Conclusions: We found no effect of the intervention on primary or secondary outcomes. In tertiary outcomes, patients in the intervention group reported higher levels of recovery compared to the control group.
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Background Various paper-based mood charting instruments are used in the monitoring of symptoms in bipolar disorder. During recent years an increasing number of electronic self-monitoring tools have been developed. The objectives of this systematic review were 1) to evaluate the validity of electronic self-monitoring tools as a method of evaluating mood compared to clinical rating scales for depression and mania and 2) to investigate the effect of electronic self-monitoring tools on clinically relevant outcomes in bipolar disorder. Methods A systematic review of the scientific literature, reported according to the Preferred Reporting items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines was conducted. MEDLINE, Embase, PsycINFO and The Cochrane Library were searched and supplemented by hand search of reference lists. Databases were searched for 1) studies on electronic self-monitoring tools in patients with bipolar disorder reporting on validity of electronically self-reported mood ratings compared to clinical rating scales for depression and mania and 2) randomized controlled trials (RCT) evaluating electronic mood self-monitoring tools in patients with bipolar disorder. Results A total of 13 published articles were included. Seven articles were RCTs and six were longitudinal studies. Electronic self-monitoring of mood was considered valid compared to clinical rating scales for depression in six out of six studies, and in two out of seven studies compared to clinical rating scales for mania. The included RCTs primarily investigated the effect of heterogeneous electronically delivered interventions; none of the RCTs investigated the sole effect of electronic mood self-monitoring tools. Methodological issues with risk of bias at different levels limited the evidence in the majority of studies. Conclusions Electronic self-monitoring of mood in depression appears to be a valid measure of mood in contrast to self-monitoring of mood in mania. There are yet few studies on the effect of electronic self-monitoring of mood in bipolar disorder. The evidence of electronic self-monitoring is limited by methodological issues and by a lack of RCTs. Although the idea of electronic self-monitoring of mood seems appealing, studies using rigorous methodology investigating the beneficial as well as possible harmful effects of electronic self-monitoring are needed.
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Background: Major depression is a highly prevalent and severe mental disease. Despite the effective treatment options available, the risk of relapse is high. Interventions based on information and communication technologies generate innovative opportunities to provide support to patients after they completed treatment for depression. Materials and methods: This acceptability study evaluated the Internet-based program Apoyo, Seguimiento y Cuidado de Enfermedades a partir de Sistemas Operativos (ASCENSO) in terms of its feasibility and acceptability in a sample of 35 patients in Chile. Results: The study reveals high rates of acceptance and satisfaction among patients who actively used the program. As obstacles, patients mentioned technical problems, a lack of contact with other participants, and an insufficient connection between the program and the health service professionals. Conclusions: ASCENSO appears to be a promising complement to regular care for depression. Following improvements of the program based on participants' feedback, future research should evaluate its efficacy and cost-effectiveness.
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Introduction: Electroconvulsive treatment (ECT) is an effective treatment for severe depression but carries a risk of relapse in the following months. Methods: Major depressive disorder patients in a current episode attaining remission from ECT (17-item Hamilton Depression Rating Scale (HAM-D17) score≤9) received randomly escitalopram 10 mg, 20 mg, 30 mg or nortriptyline 100 mg as monotherapies and were followed for 6 months in a multicentre double-blind set-up. Primary endpoint was relapse (HAM-D17≥16). Results: As inclusion rate was low the study was prematurely stopped with only 47 patients randomised (20% of the planned sample size). No statistically significant between-group differences could be detected. When all patients receiving escitalopram were compared with those receiving nortriptyline, a marginal superiority of nortriptyline was found (p=0.08). One third of patients relapsed during the study period, and one third completed. Discussion: Due to small sample size, no valid efficacy inferences could be made. The outcome was poor, probably due to tapering off of non-study psychotropic drugs after randomisation; this has implications for future study designs. ClinicalTrials.gov Identifier: NCT00660062
Article
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The Major Depression Inventory (MDI) was developed to cover the universe of depressive symptoms in DSM-IV major depression as well as in ICD-10 mild, moderate, and severe depression. The objective of this study was to evaluate the standardization of the MDI as a depression severity scale using the Visual Analogue Scale (VAS) as index of external validity in accordance with the LEAD approach (Longitudinal Expert Assessment of All Data). We used data from two previously published studies in which the patients had a MINI Neuropsychiatric Interview verified diagnosis of DSM-IV major depression. The conventional VAS scores for no, mild, moderate, and severe depression were used for the standardization of the MDI. The inter-correlation for the MDI with the clinician ratings (VAS, MES, HAM-D17 and HAM-D6) increased over the rating weeks in terms of Pearson coefficients. After nine weeks of therapy the coefficient ranged from 0.74 to 0.83. Using the clinician-rated VAS depression severity scale, the conventional MDI cut-off scores for no or doubtful depression, and for mild, moderate and severe depression were confirmed. Using the VAS as index of external, clinical validity, the standardization of the MDI as a measure of depression severity was accepted, with an MDI cut-off score of 21 for mild depression, 26 for moderate depression severity, and 31 for severe depression. Martiny et al. Acta Psychiatr Scand 112:117-25, 2005: None - due to trial commencement date. Straaso et al. Acta Neuropsychiatr 26:272-9; 2014: ClinicalTrials.gov ID NCT01353092 .
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The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder. A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups. Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group. These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.
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Depression is the most common mental health problem among adolescents. Despite policy guidance and governmental support to develop usable mental health services, there is still a lack of easily accessible and modern interventions available for adolescents in Finland's majority official language. Our objective was to develop a user-friendly and feasible Internet-based support system for adolescents with depression. The Internet-based support system for adolescents with depression was developed. To create this new intervention, some examples of existing interventions were studied, the theoretical basis for the intervention was described, and the health needs of adolescents identified. As an outcome of the process, the results were combined and the content and delivery of a new intervention will be described here. Six individual weekly Internet-based support sessions were delivered by a tutor over a 6-week period of time and developed to form an intervention called Depis.Net. This was an Internet-based support system for adolescents with depression tailored to improve self-management skills and increase awareness of their own well-being and mental health. The intervention was accessible via an electronic platform, which was secured and password protected for users. The intervention on the Depis.Net website consisted of elements identifying adolescents' needs, and offering self-monitoring, access to health information and self-reflective written exercises. An educated nurse tutor gave written feedback to each adolescent via the electronic platform. An Internet-based support system for adolescents with depression was developed using a systematic approach with four steps. This was done to ensure that the intervention had a sound theoretical background and at the same time caters flexibly for the problems that adolescents commonly face in their daily lives. Its potential for adolescents visiting outpatient clinics will be evaluated in the next phase by means of a randomized controlled trial.
Conference Paper
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Daybuilder is an experimental smartphone app intended to support people with depression. It was designed in collaboration with six participants who had all received antidepressant medication within the last two years. The Daybuilder prototype was field tested with the same six participants for three to four weeks. All participants were interested in using an application like Daybuilder, immediately or in the future if they were to suffer from depression again. The study has shown it possible to design a smartphone app that people with depression find interesting and potentially supportive in their daily lives and in their clinical treatment. In this project we chose to work directly with the depressive people, without involving clinicians, in an effort to get as close as possible to the participants' needs and concerns. This approach caused certain difficulties in recruitment, required adaptation of design activities, and consideration of certain ethical issues. The seriousness and prevalence of depression in society make it urgent as a next step to do a comprehensive study to clarify possible clinical effects of using smartphone apps for this special user group.
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Background: Little is known about whether treatment in a specialised out-patient mood disorder clinic improves long-term prognosis for patients discharged from initial psychiatric hospital admissions for bipolar disorder. Aims: To assess the effect of treatment in a specialised out-patient mood disorder clinic v. standard decentralised psychiatric treatment among patients discharged from one of their first three psychiatric hospital admissions for bipolar disorder. Method: Patients discharged from their first, second or third hospital admission with a single manic episode or bipolar disorder were randomised to treatment in a specialised out-patient mood disorder clinic or standard care (ClinicalTrials.gov: NCT00253071). The primary outcome measure was readmission to hospital, which was obtained from the Danish Psychiatric Central Register. Results: A total of 158 patients with mania/bipolar disorder were included. The rate of readmission to hospital was significantly decreased for patients treated in the mood disorder clinic compared with standard treatment (unadjusted hazard ratio 0.60, 95% CI 0.37-0.97, P = 0.034). Patients treated in the mood disorder clinic more often used a mood stabiliser or an antipsychotic and satisfaction with treatment was more prevalent than among patients who received standard care. Conclusions: Treatment in a specialised mood disorder clinic early in the course of bipolar disorder substantially reduces readmission to a psychiatric hospital and increases satisfaction with care.
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Objective. To re-analyse the Spanish outpatient study on the various versions of the Hamilton Depression Scale (HAM-D) by using item-response theory models for measuring unidimensionality. Methods. The Mokken analysis, based on the coefficient of homogeneity, was used. A coefficient of 0.40 or higher was accepted for unidimensionality. The three HAM-D versions were compared: HAM-D6 (core items of depression), HAM-D17 and HAM-D21. Results. In total, 113 of the 116 patients included in the study completed the planned treatment period of 6 weeks. As the Mokken analysis depends as much on the sample of patients under examination (dispersion of scores on the item) as on the scale itself, the endpoint was used. For HAM-D6, but not for HAM-D17 or HAM-D21, the coefficient of homogeneity was acceptable (0.44). Conclusion. The HAM-D6 is a valid version of the Hamilton Scale to be recommended for monitoring depressed patients in antidepressant therapy in the outpatient setting.
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Background: Little is known on whether centralised and specialised combined pharmacological and psychological intervention in the early phase of severe unipolar depression improve prognosis. The aim of the present study was to assess the benefits and harms of centralised and specialised secondary care intervention in the early course of severe unipolar depression. Methods: A randomised multicentre trial with central randomisation and blinding in relation to the primary outcome comparing a centralised and specialised outpatient intervention program with standard decentralised psychiatric treatment. The interventions were offered at discharge from first, second, or third hospitalisation due to a single depressive episode or recurrent depressive disorder. The primary outcome was time to readmission to psychiatric hospital. The data on re-hospitalisation was obtained from the Danish Psychiatric Central Register. The secondary and tertiary outcomes were severity of depressive symptoms according to the Major Depression Inventory, adherence to medical treatment, and satisfaction with treatment according to the total score on the Verona Service Satisfaction Scale-Affective Disorder (VSSS-A). These outcomes were assessed using questionnaires one year after discharge from hospital. Results: A total of 268 patients with unipolar depression were included. There was no significant difference in the time to readmission (unadjusted hazard ratio 0.89, 95% confidence interval 0.60 to 1.32; log rank: χ(2) = 0.3, d.f. = 1, p = 0.6); severity of depressive symptoms (mood disorder clinic: median 21.6, quartiles 9.7-31.2 versus standard treatment: median 20.2, quartiles 10.0-29.8; p = 0.7); or the prevalence of patients in antidepressant treatment (73.9% versus 80.0%, p = 0.2). Centralised and specialised secondary care intervention resulted in significantly higher satisfaction with treatment (131 (SD 31.8) versus 107 (SD 25.6); p<0.001). Conclusions: Centralised and specialised secondary care intervention in the early course of severe unipolar depression resulted in no significant effects on time to rehospitalisation, severity of symptoms, or use of antidepressants, but increased patient satisfaction. Trial registration: ClinicalTrials.gov NCT00253071.
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In 2005, we presented for the first time overall estimates of annual costs for brain disorders (mental and neurologic disorders) in Europe. This new report presents updated, more accurate, and comprehensive 2010 estimates for 30 European countries. One-year prevalence and annual cost per person of 19 major groups of disorders are based on 'best estimates' derived from systematic literature reviews by panels of experts in epidemiology and health economics. Our cost estimation model was populated with national statistics from Eurostat to adjust to 2010 values, converting all local currencies to Euros (€), imputing cost for countries where no data were available, and aggregating country estimates to purchasing power parity-adjusted estimates of the total cost of brain disorders in Europe in 2010. Total European 2010 cost of brain disorders was €798 billion, of which direct health care cost 37%, direct non-medical cost 23%, and indirect cost 40%. Average cost per inhabitant was €5.550. The European average cost per person with a disorder of the brain ranged between €285 for headache and €30 000 for neuromuscular disorders. Total annual cost per disorder (in billion € 2010) was as follows: addiction 65.7; anxiety disorders 74.4; brain tumor 5.2; child/adolescent disorders 21.3; dementia 105.2; eating disorders 0.8; epilepsy 13.8; headache 43.5; mental retardation 43.3; mood disorders 113.4; multiple sclerosis 14.6; neuromuscular disorders 7.7; Parkinson's disease 13.9; personality disorders 27.3; psychotic disorders 93.9; sleep disorders 35.4; somatoform disorder 21.2; stroke 64.1; and traumatic brain injury 33.0. Our cost model revealed that brain disorders overall are much more costly than previously estimated constituting a major health economic challenge for Europe. Our estimate should be regarded as conservative because many disorders or cost items could not be included because of lack of data.
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The ubiquitous nature of mobile phones and their increasing functionality make them an ideal medium for the delivery of large-scale public health information and interventions. While mobile phones have been used to this end in behavioural and physical health settings, their role in monitoring and managing mental health is in its infancy. The purpose of this paper is (1) to provide an overview of the field of mobile mental health and (2) by way of illustration, describe an initial proof of concept study carried out to assess the potential utility and effectiveness of a newly developed mobile phone and web-based program in the management of mild-to-moderate stress, anxiety and depression. Over 6 weeks, participants were given access to "myCompass": an interactive self-help program, which includes real-time self-monitoring with short message service prompts and brief online modules grounded in cognitive behavioural therapy. Preliminary analyses found that participants' symptoms of stress, anxiety, depression and overall psychological distress were significantly reduced after using myCompass. Improvements were also found in functional impairment and self-efficacy. These preliminary results support the feasibility of implementing mobile phone-based interventions with the potential of improving psychological wellbeing.
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Depression and anxiety disorders are common and treatable with cognitive behavior therapy (CBT), but access to this therapy is limited. Review evidence that computerized CBT for the anxiety and depressive disorders is acceptable to patients and effective in the short and longer term. Systematic reviews and data bases were searched for randomized controlled trials of computerized cognitive behavior therapy versus a treatment or control condition in people who met diagnostic criteria for major depression, panic disorder, social phobia or generalized anxiety disorder. Number randomized, superiority of treatment versus control (Hedges g) on primary outcome measure, risk of bias, length of follow up, patient adherence and satisfaction were extracted. 22 studies of comparisons with a control group were identified. The mean effect size superiority was 0.88 (NNT 2.13), and the benefit was evident across all four disorders. Improvement from computerized CBT was maintained for a median of 26 weeks follow-up. Acceptability, as indicated by adherence and satisfaction, was good. Research probity was good and bias risk low. Effect sizes were non-significantly higher in comparisons with waitlist than with active treatment control conditions. Five studies comparing computerized CBT with traditional face-to-face CBT were identified, and both modes of treatment appeared equally beneficial. Computerized CBT for anxiety and depressive disorders, especially via the internet, has the capacity to provide effective acceptable and practical health care for those who might otherwise remain untreated. Australian New Zealand Clinical Trials Registry ACTRN12610000030077.
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Newer antidepressants have increasingly been used during the past decade. These drugs may increase compliance and reduce the risk of cycle acceleration in affective disorders. To investigate the naturalistic longitudinal course of illness in patients with depressive or bipolar disorder following the use of recently introduced drugs. The rates of relapse leading to hospitalisation after successive episodes were calculated in a case register study including all hospital admissions of patients with primary affective disorder in Denmark during 1994-1999. Altogether, 9417 patients had a diagnosis of depressive disorder and 1106 patients had a diagnosis of mania or bipolar disorder, at first-ever discharge. The rate of relapse leading to hospitalisation increased with the number of previous episodes in both depressive and bipolar disorders. However, the effect of episodes was not significant for men. The rate of relapse did not decline during the study period. The course of severe depressive and bipolar disorders has remained roughly the same despite introduction of new treatments.
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Persons with a history of admission to a psychiatric hospital are at high risk for suicide, but little is known about how this is influenced by factors related to psychiatric hospitalization. To explore suicide risk according to time since admission, diagnosis, length of hospital treatment, and number of prior hospitalizations. Nested case-control design. Individual data are drawn from various Danish longitudinal registers. All 13 681 male and 7488 female suicides committed in Denmark from January 1, 1981, to December 31, 1997, and 423 128 population control subjects matched for sex, age, and calendar time of suicide. Main Outcome Measure Risk of suicide is estimated by conditional logistic regression. Data are adjusted for socioeconomic factors. This study demonstrates that there are 2 sharp peaks of risk for suicide around psychiatric hospitalization, one in the first week after admission and another in the first week after discharge; suicide risk is significantly higher in patients who received less than the median duration of hospital treatment; affective disorders have the strongest impact on suicide risk in terms of its effect size and population attributable risk; and suicide risk associated with affective and schizophrenia spectrum disorders declines quickly after treatment and recovery, while the risk associated with substance abuse disorders declines relatively slower. This study also indicates that an admission history increases suicide risk relatively more in women than in men; and suicide risk is substantial for substance disorders and for multiple admissions in women but not in men. Suicide risk peaks in periods immediately after admission and discharge. The risk is particularly high in persons with affective disorders and in persons with short hospital treatment. These findings should lead to systematic evaluation of suicide risk among inpatients before discharge and corresponding outpatient treatment, and family support should be initiated immediately after the discharge.
Book
Effectively measuring the usability of any product requires choosing the right metric, applying it, and effectively using the information it reveals. Measuring the User Experience provides the first single source of practical information to enable usability professionals and product developers to do just that. Authors Tullis and Albert organize dozens of metrics into six categories: performance, issues-based, self-reported, web navigation, derived, and behavioral/physiological. They explore each metric, considering best methods for collecting, analyzing, and presenting the data. They provide step-by-step guidance for measuring the usability of any type of product using any type of technology. Presents criteria for selecting the most appropriate metric for every case Takes a product and technology neutral approach Presents in-depth case studies to show how organizations have successfully used the metrics and the information they revealed.
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Background. Interventions based on the experience sampling method (ESM) are ideally suited to provide insight into personal, contextualized affective patterns in the flow of daily life. Recently, we showed that an ESM-intervention focusing on positive affect was associated with a decrease in symptoms in patients with depression. The aim of the present study was to examine whether ESM-intervention increased patient empowerment. Methods. Depressed out-patients (n = 102) receiving psychopharmacological treatment who had participated in a randomized controlled trial with three arms: (i) an experimental group receiving six weeks of ESM self-monitoring combined with weekly feedback sessions, (ii) a pseudo-experimental group participating in six weeks of ESM self-monitoring without feedback, and (iii) a control group (treatment as usual only). Patients were recruited in the Netherlands between January 2010 and February 2012. Self-report empowerment scores were obtained pre- and post-intervention. Results. There was an effect of group × assessment period, indicating that the experimental (B = 7.26, P = 0.061, d = 0.44, statistically imprecise) and pseudo-experimental group (B = 11.19, P = 0.003, d = 0.76) increased more in reported empowerment compared to the control group. In the pseudo-experimental group, 29% of the participants showed a statistically reliable increase in empowerment score and 0% reliable decrease compared to 17% reliable increase and 21% reliable decrease in the control group. The experimental group showed 19% reliable increase and 4% reliable decrease. Conclusions. These findings tentatively suggest that self-monitoring to complement standard antidepressant treatment may increase patients’ feelings of empowerment. Further research is necessary to investigate long-term empowering effects of self-monitoring in combination with person-tailored feedback.
Article
The literature regarding cognitive symptoms in major depressive disorder (MDD) is vast and often contradictory. To provide clinicians with a concise understanding of these prevalent and disabling symptoms, this overview describes what is known regarding cognitive symptoms in patients with MDD, the limitations of the current literature, and the implications of these data for current and future clinical practice. PubMed searches were conducted to identify studies, meta-analyses, and systematic reviews evaluating cognitive function (not cognitive bias) in patients with MDD. Search terms used in combination with MDD were cognition, cognitive dysfunction, memory, psychomotor processing, and executive function. Searches were limited to articles available in the English language and those published between April 2007 and March 2012. Additional studies and those describing screening tools were identified using reference lists and PubMed "related citations." Ongoing trials were identified by searching for cognitive dysfunction and MDD at www.ClinicalTrials.gov. Relevant articles were obtained and reviewed by the author. Small sample size and inconsistent assessment tools were identified as major limitations of studies assessing clinical characteristics and risk factors for cognitive symptoms. Meta-analyses and systematic reviews were used to mitigate this limitation. Cognitive symptoms of depression are prevalent and associated with earlier illness onset and longer episode duration. They can have an adverse impact on the treatment course of MDD as well as on functional recovery in depression. Further studies are needed to help determine whether certain treatments can be more effective than others at targeting these symptoms.
Article
Major Depression is a highly prevalent, disabling disorder associated with loss of quality of life and large economic burden for the society. Depressive disorders often follow a chronic or recurrent course. The risk of relapses increases with each additional episode. The Internet-deliverable intervention strategy SUMMIT (SUpportive Monitoring and Disease Management over the InTernet) for patients with recurrent depression has been developed with the main objective to prolong symptom-free phases and to shorten symptom-loaden phases. This paper describes the study design of a six-sites, three-arm, randomized clinical trial intended to evaluate the efficacy of this novel strategy compared to treatment as usual (TAU). Two hundred thirty six patients who had been treated for their (at least) third depressive episode in one of the six participating psychiatric centers were randomized into one of three groups: 1) TAU plus a twelve-month SUMMIT program participation with personal support or 2) TAU plus a twelve-month SUMMIT program participation without personal support, or 3) TAU alone. Primary outcome of this study is defined as the number of "well weeks" over 24months after index treatment assessed by blind evaluators based on the Longitudinal Interval Follow-Up Evaluation. If efficacious, the low monetary and nonmonetary expenditures of this automated, yet individualized intervention may open new avenues for providing an acceptable, convenient, and affordable long-term disease management strategy to people with a chronic mental condition such as recurrent depression.
Article
Recent advances in information technology (IT) coupled with the increased ubiquitous nature of information technology (IT) present unique opportunities for improving diabetes self-management. The objective of this paper is to determine, in a systematic review, how IT has been used to improve self-management for adults with Type 1 and Type 2 diabetes. The review covers articles extracted from relevant databases using search terms related information technology and diabetes self-management published after 1970 until August 2012. Additional articles were extracted using the citation map in Web of Science. Articles representing original research describing the use of IT as an enabler for self-management tasks performed by the patient are included in the final analysis. Overall, 74% of studies showed some form of added benefit, 13% articles showed no-significant value provided by IT, and 13% of articles did not clearly define the added benefit due to IT. Information technologies used included the Internet (47%), cellular phones (32%), telemedicine (12%), and decision support techniques (9%). Limitations and research gaps identified include usability, real-time feedback, integration with provider electronic medical record (EMR), as well as analytics and decision support capabilities. There is a distinct need for more comprehensive interventions, in which several technologies are integrated in order to be able to manage chronic conditions such as diabetes. Such IT interventions should be theoretically founded and should rely on principles of user-centered and socio-technical design in its planning, design and implementation. Moreover, the effectiveness of self-management systems should be assessed along multiple dimensions: motivation for self-management, long-term adherence, cost, adoption, satisfaction and outcomes as a final result.
Article
The onset of action of antidepressants often takes 4 to 6 weeks. The antidepressant effect of wake therapy (sleep deprivation) comes within hours but carries a risk of relapse. The objective of this study was to investigate whether a new chronotherapeutic intervention combining wake therapy with bright light therapy and sleep time stabilization could induce a rapid and sustained augmentation of response and remission in major depressive disorder. 75 adult patients with DSM-IV major depressive disorder, recruited from psychiatric wards, psychiatric specialist practices, or general medical practices between September 2005 and August 2008, were randomly assigned to a 9-week chronotherapeutic intervention using wake therapy, bright light therapy, and sleep time stabilization (n = 37) or a 9-week intervention using daily exercise (n = 38). Patients were evaluated at a psychiatric research unit. The study period had a 1-week run-in phase in which all patients began treatment with duloxetine. This phase was followed by a 1-week intervention phase in which patients in the wake therapy group did 3 wake therapies in combination with daily morning light therapy and sleep time stabilization and patients in the exercise group began daily exercise. This phase was followed by a 7-week continuation phase with daily light therapy and sleep time stabilization or daily exercise. The 17-item Hamilton Depression Rating Scale was the primary outcome measure, and the assessors were blinded to patients' treatment allocation. Both groups responded well to treatment. Patients in the wake therapy group did, however, have immediate and clinically significantly better response and remission compared to the exercise group. Thus, immediately after the intervention phase (week 2), response was obtained in 41.4% of wake therapy patients versus 12.8% of exercise patients (odds ratio [OR] = 4.8; 95% CI, 1.7-13.4; P = .003), and remission was obtained in 23.9% of wake therapy patients versus 5.4% of exercise patients (OR = 5.5; 95% CI, 1.7-17.8; P = .004). These superior response and remission rates obtained by the wake therapy patients were sustained for the whole study period. At week 9, response was obtained in 71.4% of wake therapy patients versus 47.3% of exercise patients (OR = 2.8; 95% CI, 1.1-7.3; P = .04), and remission was obtained in 45.6% of wake therapy patients and 23.1% of exercise patients (OR = 2.8; 95% CI, 1.1-7.3, P = .04). All treatment elements were well tolerated. Patients treated with wake therapy in combination with bright light therapy and sleep time stabilization had an augmented and sustained antidepressant response and remission compared to patients treated with exercise, who also had a clinically relevant antidepressant response. ClinicalTrials.gov identifier: NCT00149110.
Article
Technology-based self-help and minimal contact therapies have been proposed as effective and low-cost interventions for anxiety and mood disorders. The present article reviews the literature published before 2010 on these treatments for anxiety and depression using self-help and decreased therapist-contact interventions. Treatment studies are examined by disorder as well as amount of therapist contact, ranging from self-administered therapy and predominantly self-help interventions to minimal contact therapy where the therapist is actively involved in treatment but to a lesser degree than traditional therapy and predominantly therapist-administered treatments involving regular contact with a therapist for a typical number of sessions. In the treatment of anxiety disorders, it is concluded that self-administered and predominantly self-help interventions are most effective for motivated clients. Conversely, minimal-contact therapies have demonstrated efficacy for the greatest variety of anxiety diagnoses when accounting for both attrition and compliance. Additionally, predominantly self-help computer-based cognitive and behavioral interventions are efficacious in the treatment of subthreshold mood disorders. However, therapist-assisted treatments remain optimal in the treatment of clinical levels of depression. Although the most efficacious amount of therapist contact varies by disorder, computerized treatments have been shown to be a less-intensive, cost-effective way to deliver empirically validated treatments for a variety of psychological problems.
Article
This systematic review examines the economic and human costs of depression and the potential savings associated with improvement in patient adherence to treatment with antidepressants through the use of enhanced-care programs. A MEDLINE search was conducted for papers published on the health economics and costs of depression and compliance, adherence, and persistence. Compliance data collected through the online antidepressant compliance support website iCAN (www.ican.co.uk) were compared with data for patients with depression from the IMS Disease Analyzer UK database. Depression frequently causes unemployment, absenteeism, and presenteeism, which results in significantly reduced productivity. Indirect costs of depression accounted for more than $50 billion, whereas direct costs resulted in expenditure of $26 billion, in the US in 2000. Improving patients' compliance with their antidepressant medication results in improved outcomes and prolongs remission from depression, increasing work productivity, and thus reducing overall costs. The implementation of remote enhanced-care programs may improve compliance and reduce overall costs. Novel methods for delivering enhanced-care programs to assist in maintaining compliance have the potential to further reduce costs and should be a focus of future research. In conclusion, depression is a common disorder with a high economic impact. Enhanced-care programs may lower costs associated with depression and improve patients' lives.
Article
Open access websites which deliver cognitive and behavioral interventions for anxiety and depression are characterised by poor adherence. We need to understand more about adherence in order to maximize the impact of Internet-based interventions on the disease burden associated with common mental disorders. The aims of this paper are to review briefly the adherence literature with respect to Internet interventions and to investigate the rates of dropout and compliance in randomized controlled trials of anxiety and depression Web studies. A systematic review of randomized controlled trials using Internet interventions for anxiety and depression was conducted, and data was collected on dropout and adherence, predictors of adherence, and reasons for dropout. Relative to reported rates of dropout from open access sites, the present study found that the rates of attrition in randomized controlled trials were lower, ranging from approximately 1 - 50%. Predictors of adherence included disease severity, treatment length, and chronicity. Very few studies formally examined reasons for dropout, and most studies failed to use appropriate statistical techniques to analyze missing data. Dropout rates from randomized controlled trials of Web interventions are low relative to dropout from open access websites. The development of theoretical models of adherence is as important in the area of Internet intervention research as it is in the behavioral health literature. Disease-based factors in anxiety and depression need further investigation.
Article
The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-IV and ICD-10 psychiatric disorders. With an administration time of approximately 15 minutes, it was designed to meet the need for a short but accurate structured psychiatric interview for multicenter clinical trials and epidemiology studies and to be used as a first step in outcome tracking in nonresearch clinical settings. The authors describe the development of the M.I.N.I. and its family of interviews: the M.I.N.I.-Screen, the M.I.N.I.-Plus, and the M.I.N.I.-Kid. They report on validation of the M.I.N.I. in relation to the Structured Clinical Interview for DSM-III-R, Patient Version, the Composite International Diagnostic Interview, and expert professional opinion, and they comment on potential applications for this interview.
Article
Evaluation of antidepressant drug efficacy requires adequate rating scales for measuring the severity of depression. However, to measure the illness severity by such a total score, the scale needs to fulfil criteria of unidimensionality. On this background, we aimed at comparing the unidimensionality of the Bech-Rafaelsen Melancholia Scale (MES) and the 17-item Hamilton Depression Rating Scale (HAM-D(17)). A total of 1629 patients aged between 18 and 65 years with a major depressive episode were treated openly with sertraline at a fixed oral dose of 50 mg daily during 4 weeks. The HAM-D(17) and the MES were applied at baseline and at weeks 2 and 4. Unidimensionality was tested with Mokken and Rasch analysis. Unidimensionality of the HAM-D(17) could not be confirmed. However, the 6-item Hamilton Depression Subscale (HAM-D(6)), was accepted by the Rasch analysis both at baseline and after 2 and 4 weeks of therapy. For the MES (as well as for the HAM-D(6)), a Loevinger coefficient of homogeneity above 0.40 (suggesting acceptance) was found at week 4. The HAM-D(6) and the MES did fulfil criteria for unidimensionality while the HAM-D(17) did not. Therefore, the extended use of the HAM-D(17) in drug trials may be questioned.
Article
In an ongoing effort of this Journal to develop and further the theories, models, and best practices around eHealth research, this paper argues for the need for a "science of attrition", that is, a need to develop models for discontinuation of eHealth applications and the related phenomenon of participants dropping out of eHealth trials. What I call "law of attrition" here is the observation that in any eHealth trial a substantial proportion of users drop out before completion or stop using the application. This feature of eHealth trials is a distinct characteristic compared to, for example, drug trials. The traditional clinical trial and evidence-based medicine paradigm stipulates that high dropout rates make trials less believable. Consequently eHealth researchers tend to gloss over high dropout rates, or not to publish their study results at all, as they see their studies as failures. However, for many eHealth trials, in particular those conducted on the Internet and in particular with self-help applications, high dropout rates may be a natural and typical feature. Usage metrics and determinants of attrition should be highlighted, measured, analyzed, and discussed. This also includes analyzing and reporting the characteristics of the subpopulation for which the application eventually "works", ie, those who stay in the trial and use it. For the question of what works and what does not, such attrition measures are as important to report as pure efficacy measures from intention-to-treat (ITT) analyses. In cases of high dropout rates efficacy measures underestimate the impact of an application on a population which continues to use it. Methods of analyzing attrition curves can be drawn from survival analysis methods, eg, the Kaplan-Meier analysis and proportional hazards regression analysis (Cox model). Measures to be reported include the relative risk of dropping out or of stopping the use of an application, as well as a "usage half-life", and prediction models reporting demographic usage discontinuation in a population. Differential dropout or usage rates between two interventions could be a standard metric for the "usability efficacy" of a system. A "run-in and withdrawal" trial design is suggested as a methodological innovation for Internet-based trials with a high number of initial dropouts/nonusers and a stable group of hardcore users.
LøventoftPKNørregardLBFrøkjærEDesigning Daybuilder: an experimental app to support people with depression2012615Proceedings of the 12th Participatory Design Conferencexploratory Papers, Workshop Descriptions, Industry Cases
Designing Daybuilder: an experimental app to support people with depression
  • P K Løventoft
  • L B Nørregard
  • E Frøkjaer
Løventoft PK, Nørregard LB, Frøkjaer E. Designing Daybuilder: an experimental app to support people with depression.