Help for insomnia from the app store? A standardized rating of mobile health applications claiming to target insomnia.

A large number of mobile health applications claiming to target insomnia are available in commercial app stores. However, limited information on the quality of these mobile health applications exists. The present study aimed to systematically search the European Google Play and Apple App Store for mobile health applications targeting insomnia, and evaluate the quality, content, evidence base and potential therapeutic benefit. Eligible mobile health applications were evaluated by two independent reviewers using the Mobile Application Rating Scale-German, which ranges from 1 - inadequate to 5 - excellent. Of 2236 identified mobile health applications, 53 were included in this study. Most mobile health applications (68%) had a moderate overall quality. Concerning the four main subscales of the Mobile Application Rating Scale-German, functionality was rated highest (M = 4.01, SD = 0.52), followed by information quality (M = 3.49, SD = 0.72), aesthetics (M = 3.31, SD = 1.04) and engagement (M = 3.02, SD = 1.03). While scientific evidence was identified for 10 mobile health applications (19%), only one study employed a randomized controlled design. Fifty mobile health applications featured sleep hygiene/psychoeducation (94%), 27 cognitive therapy (51%), 26 relaxation methods (49%), 24 stimulus control (45%), 16 sleep restriction (30%) and 24 sleep diaries (45%). Mobile health applications may have the potential to improve the care of insomnia. Yet, data on the effectiveness of mobile health applications are scarce, and this study indicates a large variance in the quality of the mobile health applications. Thus, independent information platforms are needed to provide healthcare seekers and providers with reliable information on the quality and content of mobile health applications.

Predictors of Dropout in a Digital Intervention for the Prevention and Treatment of Depression in Patients With Chronic Back Pain: Secondary Analysis of Two Randomized Controlled Trials.

BACKGROUND: Depression is a common comorbid condition in individuals with chronic back pain (CBP), leading to poorer treatment outcomes and increased medical complications. Digital interventions have demonstrated efficacy in the prevention and treatment of depression; however, high dropout rates are a major challenge, particularly in clinical settings. OBJECTIVE: This study aims to identify the predictors of dropout in a digital intervention for the treatment and prevention of depression in patients with comorbid CBP. We assessed which participant characteristics may be associated with dropout and whether intervention usage data could help improve the identification of individuals at risk of dropout early on in treatment. METHODS: Data were collected from 2 large-scale randomized controlled trials in which 253 patients with a diagnosis of CBP and major depressive disorder or subclinical depressive symptoms received a digital intervention for depression. In the first analysis, participants' baseline characteristics were examined as potential predictors of dropout. In the second analysis, we assessed the extent to which dropout could be predicted from a combination of participants' baseline characteristics and intervention usage variables following the completion of the first module. Dropout was defined as completing <6 modules. Analyses were conducted using logistic regression. RESULTS: From participants' baseline characteristics, lower level of education (odds ratio [OR] 3.33, 95% CI 1.51-7.32) and both lower and higher age (a quadratic effect; age: OR 0.62, 95% CI 0.47-0.82, and age2: OR 1.55, 95% CI 1.18-2.04) were significantly associated with a higher risk of dropout. In the analysis that aimed to predict dropout following completion of the first module, lower and higher age (age: OR 0.60, 95% CI 0.42-0.85; age2: OR 1.59, 95% CI 1.13-2.23), medium versus high social support (OR 3.03, 95% CI 1.25-7.33), and a higher number of days to module completion (OR 1.05, 95% CI 1.02-1.08) predicted a higher risk of dropout, whereas a self-reported negative event in the previous week was associated with a lower risk of dropout (OR 0.24, 95% CI 0.08-0.69). A model that combined baseline characteristics and intervention usage data generated the most accurate predictions (area under the receiver operating curve [AUC]=0.72) and was significantly more accurate than models based on baseline characteristics only (AUC=0.70) or intervention usage data only (AUC=0.61). We found no significant influence of pain, disability, or depression severity on dropout. CONCLUSIONS: Dropout can be predicted by participant baseline variables, and the inclusion of intervention usage variables may improve the prediction of dropout early on in treatment. Being able to identify individuals at high risk of dropout from digital health interventions could provide intervention developers and supporting clinicians with the ability to intervene early and prevent dropout from occurring.

Mobile Apps for the Management of Gastrointestinal Diseases: Systematic Search and Evaluation Within App Stores.

BACKGROUND: Gastrointestinal diseases are associated with substantial cost in health care. In times of the COVID-19 pandemic and further digitalization of gastrointestinal tract health care, mobile health apps could complement routine health care. Many gastrointestinal health care apps are already available in the app stores, but the quality, data protection, and reliability often remain unclear. OBJECTIVE: This systematic review aimed to evaluate the quality characteristics as well as the privacy and security measures of mobile health apps for the management of gastrointestinal diseases. METHODS: A web crawler systematically searched for mobile health apps with a focus on gastrointestinal diseases. The identified mobile health apps were evaluated using the Mobile Application Rating Scale (MARS). Furthermore, app characteristics, data protection, and security measures were collected. Classic user star rating was correlated with overall mobile health app quality. RESULTS: The overall quality of the mobile health apps (N=109) was moderate (mean 2.90, SD 0.52; on a scale ranging from 1 to 5). The quality of the subscales ranged from low (mean 1.89, SD 0.66) to good (mean 4.08, SD 0.57). The security of data transfer was ensured only by 11 (10.1%) mobile health apps. None of the mobile health apps had an evidence base. The user star rating did not correlate with the MARS overall score or with the individual subdimensions of the MARS (all P>.05). CONCLUSIONS: Mobile health apps might have a positive impact on diagnosis, therapy, and patient guidance in gastroenterology in the future. We conclude that, to date, data security and proof of efficacy are not yet given in currently available mobile health apps.

Sample size, sample size planning, and the impact of study context: systematic review and recommendations by the example of psychological depression treatment.

BACKGROUND: Sample size planning (SSP) is vital for efficient studies that yield reliable outcomes. Hence, guidelines, emphasize the importance of SSP. The present study investigates the practice of SSP in current trials for depression. METHODS: Seventy-eight randomized controlled trials published between 2013 and 2017 were examined. Impact of study design (e.g. number of randomized conditions) and study context (e.g. funding) on sample size was analyzed using multiple regression. RESULTS: Overall, sample size during pre-registration, during SSP, and in published articles was highly correlated (r's ≥ 0.887). Simultaneously, only 7-18% of explained variance related to study design (p = 0.055-0.155). This proportion increased to 30-42% by adding study context (p = 0.002-0.005). The median sample size was N = 106, with higher numbers for internet interventions (N = 181; p = 0.021) compared to face-to-face therapy. In total, 59% of studies included SSP, with 28% providing basic determinants and 8-10% providing information for comprehensible SSP. Expected effect sizes exhibited a sharp peak at d = 0.5. Depending on the definition, 10.2-20.4% implemented intense assessment to improve statistical power. CONCLUSIONS: Findings suggest that investigators achieve their determined sample size and pre-registration rates are increasing. During study planning, however, study context appears more important than study design. Study context, therefore, needs to be emphasized in the present discussion, as it can help understand the relatively stable trial numbers of the past decades. Acknowledging this situation, indications exist that digital psychiatry (e.g. Internet interventions or intense assessment) can help to mitigate the challenge of underpowered studies. The article includes a short guide for efficient study planning.

Effectiveness of a Guided Internet- and Mobile-Based Intervention for Patients with Chronic Back Pain and Depression (WARD-BP): A Multicenter, Pragmatic Randomized Controlled Trial.

INTRODUCTION: There is neither strong evidence on effective treatments for patients with chronic back pain (CBP) and depressive disorder nor sufficiently available mental health care offers. OBJECTIVE: The aim is to assess the effectiveness of internet- and mobile-based interventions (IMI) as a scalable approach for treating depression in a routine care setting. METHODS: This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.Patients with CBP and diagnosed depressive disorder (mild to moderate severity) were recruited from 82 orthopedic rehabilitation clinics across Germany. The intervention group (IG) received a guided depression IMI tailored to CBP next to treatment-as-usual (TAU; including medication), while the control group (CG) received TAU. The primary outcome was observer-masked clinician-rated Hamilton depression severity (9-week follow-up). The secondary outcomes were: further depression outcomes, pain-related outcomes, health-related quality of life, and work capacity. Biostatistician blinded analyses using regression models were conducted by intention-to-treat and per protocol analysis. RESULTS: Between October 2015 and July 2017, we randomly assigned 210 participants (IG, n = 105; CG, n = 105), mostly with only a mild pain intensity but substantial pain disability. No statistically significant difference in depression severity between IG and CG was observed at the 9-week follow-up (ß = -0.19, 95% CI -0.43 to 0.05). Explorative secondary depression (4/9) and pain-related (4/6) outcomes were in part significant (p < 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity. CONCLUSION: The results indicate that an IMI for patients with CBP and depression in a routine care setting has limited impact on depression. Benefits in pain and health-related outcomes suggest that an IMI might still be a useful measure to improve routine care.

Stay Present with Your Phone: A Systematic Review and Standardized Rating of Mindfulness Apps in European App Stores.

BACKGROUND: Mindfulness-based interventions show positive effects on physical and mental health. For a better integration of mindfulness techniques in daily life, the use of apps may be promising. However, only a few studies have examined the quality of mindfulness apps using a validated standardized instrument. This review aims to evaluate the content, quality, and privacy features of mindfulness-focused apps from European commercial app stores. METHODS: An automated search engine (webcrawler) was used to identify mindfulness-focused apps in the European Apple App- and Google Play store. Content, quality, and privacy features were evaluated by two independent reviewers using the Mobile Application Rating Scale (MARS). The MARS assesses the subscales engagement, functionality, aesthetics, and information quality. RESULTS: Out of 605 identified apps, 192 met the inclusion criteria. The overall quality was moderate (M = 3.66, SD = 0.48). Seven apps were tested in a randomized controlled trial (RCT). Most of the apps showed a lack of data security and no privacy policy. The five apps with the highest ratings are from a credible source, include a privacy policy, and are also based on standardized mindfulness and behavior change techniques. CONCLUSIONS: The plethora of often low-quality apps in commercial app stores makes it difficult for users to identify a suitable app. Above that, the lack of scientific verification of effectiveness and shortcomings in privacy protection and security poses potential risks. So far, the potential of mindfulness-focused apps is not exploited in commercial app stores.

Further development in the assessment of psychological flexibility: validation of the German committed action questionnaire.

BACKGROUND: Psychological flexibility is considered a fundamental aspect of health. It includes six interrelated facets: 1) cognitive defusion, 2) acceptance, 3) contact with the present moment, 4) self-as-context, 5) values, and 6) committed action. To gain further insight into psychological flexibility and its effects on health, reliable and valid instruments to assess all facets are needed. Committed action is one facet that is understudied. A long and short version of a validated measure (CAQ and CAQ-8) have been developed in English. Currently, there are no German versions of the CAQ. Aim of this study is to validate German-language versions of these in a chronic pain population. METHODS: The CAQ instructions and items were translated and evaluated in a chronic pain population (N = 181). Confirmatory factor analysis and Mokken scale analysis were conducted to evaluate the German questionnaires. Correlations with health outcomes, including quality of life (SF-12), physical and emotional functioning (MPI, BPI, PHQ-9, GAD-7), pain intensity, and with other facets of psychological flexibility (CPAQ, FAH-II) were investigated for convergent validity purposes. Scale reliability was assessed by the alpha, MS, lambda-2, LCRC, and omega coefficient. RESULTS: A bifactor model consisting of one general factor and two methodological factors emerged from the analysis. Criteria for reliability and validity were met. Medium to strong correlations to health outcomes and other facets of psychological flexibility were found. Results were similar to the original English version. CONCLUSIONS: The present study presents a valid and reliable instrument to investigate committed action in German populations. Future studies could expand the present findings by evaluating the German CAQ versions in non-pain populations. The role of committed action and the wider psychological flexibility model in pain and other conditions deserves further investigation.

Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial.

BACKGROUND: People in green professions are exposed to a variety of risk factors, which could possibly enhance the development of depression. Amongst possible prevention approaches, internet- and mobile-based interventions (IMIs) have been shown to be effective and scalable. However, little is known about the effectiveness in green professions. The aim of the present study is to examine the (cost-)effectiveness of a tailored IMI program for reducing depressive symptoms and preventing the onset of clinical depression compared to enhanced treatment as usual (TAU+). METHODS: A pragmatic randomized controlled trial (RCT) will be conducted to evaluate a tailored and therapeutically guided preventive IMI program in comparison to TAU+ with follow-ups at post-treatment (9 weeks), 6-, 12-, 24-, and 36-months. Entrepreneurs in green professions, collaborating spouses, family members and pensioners (N = 360) with sufficient insurance status and at least subthreshold depression (PHQ-9 ≥ 5) are eligible for inclusion. Primary outcome is depressive symptom severity (QIDS-SR16). Secondary outcomes include incidence of depression (QIDS-SR16), quality of life (AQoL-8D) and negative treatment effects (INEP). A health-economic evaluation will be conducted from a societal perspective. The IMI program is provided by psychologists of an external service company and consists of six guided IMIs (6-8 modules, duration: 6-8 weeks) targeting different symptoms (depressive mood, depressive mood with comorbid diabetes, perceived stress, insomnia, panic and agoraphobic symptoms or harmful alcohol use). Intervention choice depends on a screening of participants' symptoms and individual preferences. The intervention phase is followed by a 12-months consolidating phase with monthly contact to the e-coach. DISCUSSION: This is the first pragmatic RCT investigating long-term effectiveness of a tailored guided IMI program for depression prevention in green professions. The present trial builds on a large-scale strategy for depression prevention in green professions. The intended implementation of the IMI program with a nationwide rollout has the potential to reduce overall depression burden and associated health care costs in case of given effectiveness. TRIAL REGISTRATION: German Clinical Trial Registration: DRKS00014000 . Registered on 09 April 2018.

Acceptance of smart sensing, its determinants, and the efficacy of an acceptance-facilitating intervention in people with diabetes: results from a randomized controlled trial.

Background: Mental health problems are prevalent among people with diabetes, yet often under-diagnosed. Smart sensing, utilizing passively collected digital markers through digital devices, is an innovative diagnostic approach that can support mental health screening and intervention. However, the acceptance of this technology remains unclear. Grounded on the Unified Theory of Acceptance and Use of Technology (UTAUT), this study aimed to investigate (1) the acceptance of smart sensing in a diabetes sample, (2) the determinants of acceptance, and (3) the effectiveness of an acceptance facilitating intervention (AFI). Methods: A total of N = 132 participants with diabetes were randomized to an intervention group (IG) or a control group (CG). The IG received a video-based AFI on smart sensing and the CG received an educational video on mindfulness. Acceptance and its potential determinants were assessed through an online questionnaire as a single post-measurement. The self-reported behavioral intention, interest in using a smart sensing application and installation of a smart sensing application were assessed as outcomes. The data were analyzed using latent structural equation modeling and t-tests. Results: The acceptance of smart sensing at baseline was average (M = 12.64, SD = 4.24) with 27.8% showing low, 40.3% moderate, and 31.9% high acceptance. Performance expectancy (γ = 0.64, p < 0.001), social influence (γ = 0.23, p = .032) and trust (γ = 0.27, p = .040) were identified as potential determinants of acceptance, explaining 84% of the variance. SEM model fit was acceptable (RMSEA = 0.073, SRMR = 0.059). The intervention did not significantly impact acceptance (γ = 0.25, 95%-CI: -0.16-0.65, p = .233), interest (OR = 0.76, 95% CI: 0.38-1.52, p = .445) or app installation rates (OR = 1.13, 95% CI: 0.47-2.73, p = .777). Discussion: The high variance in acceptance supports a need for acceptance facilitating procedures. The analyzed model supported performance expectancy, social influence, and trust as potential determinants of smart sensing acceptance; perceived benefit was the most influential factor towards acceptance. The AFI was not significant. Future research should further explore factors contributing to smart sensing acceptance and address implementation barriers.

Enhancing the acceptance of smart sensing in psychotherapy patients: findings from a randomized controlled trial.

Objective: Smart sensing has the potential to make psychotherapeutic treatments more effective. It involves the passive analysis and collection of data generated by digital devices. However, acceptance of smart sensing among psychotherapy patients remains unclear. Based on the unified theory of acceptance and use of technology (UTAUT), this study investigated (1) the acceptance toward smart sensing in a sample of psychotherapy patients (2) the effectiveness of an acceptance facilitating intervention (AFI) and (3) the determinants of acceptance. Methods: Patients (N = 116) were randomly assigned to a control group (CG) or intervention group (IG). The IG received a video AFI on smart sensing, and the CG a control video. An online questionnaire was used to assess acceptance of smart sensing, performance expectancy, effort expectancy, facilitating conditions and social influence. The intervention effects of the AFI on acceptance were investigated. The determinants of acceptance were analyzed with structural equation modeling (SEM). Results: The IG showed a moderate level of acceptance (M = 3.16, SD = 0.97), while the CG showed a low level (M = 2.76, SD = 1.0). The increase in acceptance showed a moderate effect in the intervention group (p < .05, d = 0.4). For the IG, performance expectancy (M = 3.92, SD = 0.7), effort expectancy (M = 3.90, SD = 0.98) as well as facilitating conditions (M = 3.91, SD = 0.93) achieved high levels. Performance expectancy (γ = 0.63, p < .001) and effort expectancy (γ = 0.36, p < .001) were identified as the core determinants of acceptance explaining 71.1% of its variance. The fit indices supported the model's validity (CFI = .95, TLI = .93, RMSEA = .08). Discussion: The low acceptance in the CG suggests that enhancing the acceptance should be considered, potentially increasing the use and adherence to the technology. The current AFI was effective in doing so and is thus a promising approach. The IG also showed significantly higher performance expectancy and social influence and, in general, a strong expression of the UTAUT factors. The results support the applicability of the UTAUT in the context of smart sensing in a clinical sample, as the included predictors were able to explain a great amount of the variance of acceptance.

Treatment effect heterogeneity of cognitive behavioral therapy for insomnia - A meta-analysis.

Investigation of the heterogeneity of the treatment effect (HTE) might guide the optimization of cognitive behavioral therapy for insomnia (CBT-I). This study examined HTE in CBT-I thereby analyzing if treatment setting, control group, different CBT-I components, and patient characteristics drive HTE. Randomized controlled trials investigating CBT-I were included. Bayesian random effect meta-regressions were specified to examine variances between the intervention and control groups regarding post-treatment symptom severity. Subgroup analyses analyzing treatment setting and control groups and covariate analysis analyzing treatment components and patient characteristics were specified. No significant HTE in CBT-I was found for the overall data set, settings and control groups. The covariate analyses yielded significant results for baseline severity and the treatment component relaxation therapy. Thus, this study identified potential causes for HTE in CBT-I for the first time, showing that it might be worthwhile to further examine possibilities for precision medicine in CBT-I.

The predictive value of supervised machine learning models for insomnia symptoms through smartphone usage behavior.

Introduction: Digital phenotyping can be an innovative and unobtrusive way to improve the detection of insomnia. This study explores the correlations between smartphone usage features (SUF) and insomnia symptoms and their predictive value for detecting insomnia symptoms. Methods: In an observational study of a German convenience sample, the Insomnia Severity Index (ISI) and smartphone usage data (e.g., time the screen was active, longest time the screen was inactive in the night) for the previous 7 days were obtained. SUF (e.g., min, mean) were calculated from the smartphone usage data. Correlation analyses between the ISI and SUF were conducted. For the specification of the machine learning models (ML), 80 % of the data was allocated to training, 20 % to testing, and five-fold cross-validation was used. Six algorithms (support vector machine, XGBoost, Random Forest, k-Nearest-Neighbor, Naive Bayes, and Logistic Regressions) were specified to predict ISI scores ≥15. Results: 752 participants (51.1 % female, mean ISI = 10.23, mean age = 41.92) were included in the analyses. Small correlations between some of the SUF and insomnia symptoms were found. In the ML models, sensitivity was low, ranging from 0.05 to 0.27 in the testing subsample. Random Forest and Naive Bayes were the best-performing algorithms. Yet, their AUCs (0.57, 0.58 respectively) in the testing subsample indicated a low discrimination capacity. Conclusions: Given the small magnitude of the correlations and low discrimination capacity of the ML models, SUFs, as measured in this study, do not appear to be sufficient for detecting insomnia symptoms. Further research is necessary to explore whether examining intra-individual variations and subpopulations or employing alternative smartphone sensors yields more promising outcomes.

Heterogeneity of Treatment Effects in Internet- and Mobile-Based Interventions for Depression: A Systematic Review and Meta-Analysis.

Importance: While the effects of internet- and mobile-based interventions (IMIs) for depression have been extensively studied, no systematic evidence is available regarding the heterogeneity of treatment effects (HTEs), indicating to what extent patient-by-treatment interactions exist and personalized treatment models might be necessary. Objective: To investigate the HTEs in IMIs for depression as well as their efficacy and effectiveness. Data Sources: A systematic search in Embase, MEDLINE, Central, and PsycINFO for randomized clinical trials and supplementary reference searches was conducted on October 13, 2019, and updated March 25, 2022. The search string included various terms related to digital psychotherapy, depression, and randomized clinical trials. Study Selection: Titles, abstracts, and full texts were reviewed by 2 independent researchers. Studies of all populations with at least 1 intervention group receiving an IMI for depression and at least 1 control group were eligible, if they assessed depression severity as a primary outcome and followed a randomized clinical trial (RCT) design. Data Extraction and Synthesis: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. Risk of bias was evaluated using the Cochrane Risk of Bias Tool. HTE was investigated using logarithmic variance ratios (lnVR) and effect sizes using Hedges g. Three-level bayesian meta-regressions were conducted. Main Outcomes and Measures: Heterogeneity of treatment effects was the primary outcome of this study; magnitudes of treatment effect sizes were the secondary outcome. Depression severity was measured by different self-report and clinician-rated scales in the included RCTs. Results: The systematic review of 102 trials included 19 758 participants (mean [SD] age, 39.9 [10.58] years) with moderate depression severity (mean [SD] in Patient Health Questionnaire-9 score, 12.81 [2.93]). No evidence for HTE in IMIs was found (lnVR = -0.02; 95% credible interval [CrI], -0.07 to 0.03). However, HTE was higher in more severe depression levels (ß̂ = 0.04; 95% CrI, 0.01 to 0.07). The effect size of IMI was medium (g = -0.56; 95% CrI, -0.46 to -0.66). An interaction effect between guidance and baseline severity was found (ß̂ = -0.24, 95% CrI, -0.03 to -0.46). Conclusions and Relevance: In this systematic review and meta-analysis of RCTs, no evidence for increased patient-by-treatment interaction in IMIs among patients with subthreshold to mild depression was found. Guidance did not increase effect sizes in this subgroup. However, the association of baseline severity with HTE and its interaction with guidance indicates a more sensitive, guided, digital precision approach would benefit individuals with more severe symptoms. Future research in this population is needed to explore personalization strategies and fully exploit the potential of IMI.

Optimizing the predictive power of depression screenings using machine learning.

Objective: Mental health self-report and clinician-rating scales with diagnoses defined by sum-score cut-offs are often used for depression screening. This study investigates whether machine learning (ML) can detect major depressive episodes (MDE) based on screening scales with higher accuracy than best-practice clinical sum-score approaches. Methods: Primary data was obtained from two RCTs on the treatment of depression. Ground truth were DSM 5 MDE diagnoses based on structured clinical interviews (SCID) and PHQ-9 self-report, clinician-rated QIDS-16, and HAM-D-17 were predictors. ML models were trained using 10-fold cross-validation. Performance was compared against best-practice sum-score cut-offs. Primary outcome was the Area Under the Curve (AUC) of the Receiver Operating Characteristic curve. DeLong's test with bootstrapping was used to test for differences in AUC. Secondary outcomes were balanced accuracy, precision, recall, F1-score, and number needed to diagnose (NND). Results: A total of k = 1030 diagnoses (no diagnosis: k = 775; MDE: k = 255) were included. ML models achieved an AUCQIDS-16 = 0.94, AUCHAM-D-17 = 0.88, and AUCPHQ-9 = 0.83 in the testing set. ML AUC was significantly higher than sum-score cut-offs for QIDS-16 and PHQ-9 (ps ≤ 0.01; HAM_D-17: p = 0.847). Applying optimal prediction thresholds, QIDS-16 classifier achieved clinically relevant improvements (Δbalanced accuracy = 8%, ΔF1-score = 14%, ΔNND = 21%). Differences for PHQ_9 and HAM-D-17 were marginal. Conclusions: ML augmented depression screenings could potentially make a major contribution to improving MDE diagnosis depending on questionnaire (e.g., QIDS-16). Confirmatory studies are needed before ML enhanced screening can be implemented into routine care practice.

Mechanisms of change in digital cognitive behavioral therapy for depression in patients with chronic back pain: A mediation analysis of a multicenter randomized clinical trial.

BACKGROUND: While there is evolving knowledge on change processes of digital cognitive behavioral therapy (CBT) in the treatment of depression, little is known about how these interventions produce therapeutic change in the comorbid constellation of chronic back pain (CBP). Here, we examined whether the effects of a digital intervention to treat depression in patients with CBP are mediated by three pain-related variables (i.e., pain self-efficacy, pain-related disability, pain intensity). METHODS: This study is a secondary analysis of a randomized clinical trial conducted in routine care at 82 orthopedic clinics across Germany. In total, 209 adults with CBP and diagnosed depression (SCID interview) were randomly assigned to the intervention (n = 104) or treatment-as-usual (n = 105). Cross-lagged mediation models were estimated to investigate longitudinal mediation effects of putative mediators with depression symptom severity (PHQ-9) as primary outcome at post-treatment. RESULTS: Longitudinal mediation effects were observed for pain self-efficacy (ß = -0.094, 95%-CI [-0.174, -0.014], p = 0.021) and pain-related disability (ß = -0.068, 95%-CI [-0.130, -0.001], p = 0.047). Furthermore, the hypothesized direction of the mediation effects was supported, reversed causation did not occur. Pain intensity did not reveal a mediation effect. CONCLUSIONS: The results suggest a relevant role of pain self-efficacy and pain-related disability as change processes in the treatment of depression for patients with CBP in routine care. However, further research is needed to disclose potential reciprocal relationships of mediators, and to extend and specify our knowledge of the mechanisms of change in digital CBT for depression.

Acceptance of smart sensing: a barrier to implementation-results from a randomized controlled trial.

Background: Accurate and timely diagnostics are essential for effective mental healthcare. Given a resource- and time-limited mental healthcare system, novel digital and scalable diagnostic approaches such as smart sensing, which utilizes digital markers collected via sensors from digital devices, are explored. While the predictive accuracy of smart sensing is promising, its acceptance remains unclear. Based on the unified theory of acceptance and use of technology, the present study investigated (1) the effectiveness of an acceptance facilitating intervention (AFI), (2) the determinants of acceptance, and (3) the acceptance of adults toward smart sensing. Methods: The participants (N = 202) were randomly assigned to a control group (CG) or intervention group (IG). The IG received a video AFI on smart sensing, and the CG a video on mindfulness. A reliable online questionnaire was used to assess acceptance, performance expectancy, effort expectancy, facilitating conditions, social influence, and trust. The self-reported interest in using and the installation of a smart sensing app were assessed as behavioral outcomes. The intervention effects were investigated in acceptance using t-tests for observed data and latent structural equation modeling (SEM) with full information maximum likelihood to handle missing data. The behavioral outcomes were analyzed with logistic regression. The determinants of acceptance were analyzed with SEM. The root mean square error of approximation (RMSEA) and standardized root mean square residual (SRMR) were used to evaluate the model fit. Results: The intervention did not affect the acceptance (p = 0.357), interest (OR = 0.75, 95% CI: 0.42-1.32, p = 0.314), or installation rate (OR = 0.29, 95% CI: 0.01-2.35, p = 0.294). The performance expectancy (γ = 0.45, p < 0.001), trust (γ = 0.24, p = 0.002), and social influence (γ = 0.32, p = 0.008) were identified as the core determinants of acceptance explaining 68% of its variance. The SEM model fit was excellent (RMSEA = 0.06, SRMR = 0.05). The overall acceptance was M = 10.9 (SD = 3.73), with 35.41% of the participants showing a low, 47.92% a moderate, and 10.41% a high acceptance. Discussion: The present AFI was not effective. The low to moderate acceptance of smart sensing poses a major barrier to its implementation. The performance expectancy, social influence, and trust should be targeted as the core factors of acceptance. Further studies are needed to identify effective ways to foster the acceptance of smart sensing and to develop successful implementation strategies. Clinical Trial Registration: identifier 10.17605/OSF.IO/GJTPH.

Moderators and mediators of change of an internet-based mindfulness intervention for college students: secondary analysis from a randomized controlled trial.

Background: Existing evidence suggests internet- and mobile-based interventions (IMIs) improve depressive symptoms in college students effectively. However, there is far less knowledge about the potential mechanisms of change of mindfulness-based IMIs, which could contribute to optimizing target groups and interventions. Hence, within this secondary analysis of data from a randomized controlled trial (RCT), potential moderators and mediators of the effectiveness of the IMI StudiCare Mindfulness were investigated. Methods: Moderation and mediation analyses were based on secondary data from a RCT that examined the effectiveness of the 7-module IMI StudiCare Mindfulness in a sample of college students (intervention group: n = 217; waitlist control group: n = 127). Assessments were collected before (t0; baseline), 4 weeks after (t1; during intervention), and 8 weeks after (t2; post-intervention) randomization. Longitudinal mediation analyses using structural equation modeling were employed, with depressive symptom severity as the dependent variable. For moderation analyses, bilinear interaction models were calculated with depressive symptom severity and mindfulness at t2 as dependent variables. All data-analyses were performed on an intention-to-treat basis. Results: Mediation analyses showed a significant, full mediation of the intervention effect on depressive symptom severity through mindfulness (indirect effect, a*b = 0.153, p < 0.01). Only the number of semesters (interaction: ß = 0.24, p = 0.035) was found to moderate the intervention's effectiveness on depressive symptom severity at t2, and only baseline mindfulness (interaction: ß = -0.20, p = 0.047) and baseline self-efficacy (interaction: ß = -0.27, p = 0.012) were found to be significant moderators of the intervention effect on mindfulness at t2. Conclusion: Our results suggest a mediating role of mindfulness. Moderation analyses demonstrated that the intervention improved depressive symptom severity and mindfulness independent of most examined baseline characteristics. Future confirmatory trials will need to support these findings. Clinical Trial Registration: The trial was registered a priori at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (TRN: DRKS00014774; registration date: 18 May 2018).

Mediators of digital depression prevention in patients with chronic back pain: Findings from a multicenter randomized clinical trial.

OBJECTIVE: The mechanisms of change in digital interventions for the prevention of depression are largely unknown. Here, we explored whether five theoretically derived intervening variables (i.e., pain intensity, pain-related disability, pain self-efficacy, quality of life [QoL], and work capacity) were mediating the effectiveness of a digital intervention specifically designed to prevent depression in patients with chronic back pain (CBP). METHOD: This study is a secondary analysis of a pragmatic, observer-masked randomized clinical trial conducted at 82 orthopedic clinics in Germany. A total of 295 adults with a diagnosis of CBP and subclinical depressive symptoms were randomized to either the intervention group (n = 149) or treatment-as-usual (n = 146). Longitudinal mediation analyses were conducted with structural equation modeling and depression symptom severity as primary outcome (Patient Health Questionnaire-9 [PHQ-9]; 6 months after randomization) on an intention-to-treat basis. RESULTS: Beside the effectiveness of the digital intervention in preventing depression, we found a significant causal mediation effect for QoL as measured with the complete scale of Assessment of Quality of Life (AQoL-6D; axb: -0.234), as well as for the QoL subscales mental health (axb: -0.282) and coping (axb: -0.249). All other potential intervening variables were not significant. CONCLUSION: Our findings suggest a relevant role of QoL, including active coping, as change mechanism in the prevention of depression. Yet, more research is needed to extend and specify our knowledge on empirically supported processes in digital depression prevention. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Predicting heterogeneous treatment effects of an Internet-based depression intervention for patients with chronic back pain: Secondary analysis of two randomized controlled trials.

Background: Depression is highly prevalent among individuals with chronic back pain. Internet-based interventions can be effective in treating and preventing depression in this patient group, but it is unclear who benefits most from this intervention format. Method: In an analysis of two randomized trials (N = 504), we explored ways to predict heterogeneous treatment effects of an Internet-based depression intervention for patients with chronic back pain. Univariate treatment-moderator interactions were explored in a first step. Multilevel model-based recursive partitioning was then applied to develop a decision tree model predicting individualized treatment benefits. Results: The average effect on depressive symptoms was d = -0.43 (95 % CI: -0.68 to -0.17; 9 weeks; PHQ-9). Using univariate models, only back pain medication intake was detected as an effect moderator, predicting higher effects. More complex interactions were found using recursive partitioning, resulting in a final decision tree with six terminal nodes. The model explained a large amount of variation (bootstrap-bias-corrected R2 = 45 %), with predicted subgroup-conditional effects ranging from di = 0.24 to -1.31. External validation in a pilot trial among patients on sick leave (N = 76; R2 = 33 %) pointed to the transportability of the model. Conclusions: The studied intervention is effective in reducing depressive symptoms, but not among all chronic back pain patients. Predictions of the multivariate tree learning model suggest a pattern in which patients with moderate depression and relatively low pain self-efficacy benefit most, while no benefits arise when patients' self-efficacy is already high. If corroborated in further studies, the developed tree algorithm could serve as a practical decision-making tool.

Stress Management Apps: Systematic Search and Multidimensional Assessment of Quality and Characteristics.

BACKGROUND: Chronic stress poses risks for physical and mental well-being. Stress management interventions have been shown to be effective, and stress management apps (SMAs) might help to transfer strategies into everyday life. OBJECTIVE: This review aims to provide a comprehensive overview of the quality and characteristics of SMAs to give potential users or health professionals a guideline when searching for SMAs in common app stores. METHODS: SMAs were identified with a systematic search in the European Google Play Store and Apple App Store. SMAs were screened and checked according to the inclusion criteria. General characteristics and quality were assessed by 2 independent raters using the German Mobile Application Rating Scale (MARS-G). The MARS-G assesses quality (range 1 to 5) on the following four dimensions: (1) engagement, (2) functionality, (3) esthetics, and (4) information. In addition, the theory-based stress management strategies, evidence base, long-term availability, and common characteristics of the 5 top-rated SMAs were assessed and derived. RESULTS: Of 2044 identified apps, 121 SMAs were included. Frequently implemented strategies (also in the 5 top-rated SMAs) were psychoeducation, breathing, and mindfulness, as well as the use of monitoring and reminder functions. Of the 121 SMAs, 111 (91.7%) provided a privacy policy, but only 44 (36.4%) required an active confirmation of informed consent. Data sharing with third parties was disclosed in only 14.0% (17/121) of the SMAs. The average quality of the included apps was above the cutoff score of 3.5 (mean 3.59, SD 0.50). The MARS-G dimensions yielded values above this cutoff score (functionality: mean 4.14, SD 0.47; esthetics: mean 3.76, SD 0.73) and below this score (information: mean 3.42, SD 0.46; engagement: mean 3.05, SD 0.78). Most theory-based stress management strategies were regenerative stress management strategies. The evidence base for 9.1% (11/121) of the SMAs could be identified, indicating significant group differences in several variables (eg, stress or depressive symptoms) in favor of SMAs. Moreover, 38.0% (46/121) of the SMAs were no longer available after a 2-year period. CONCLUSIONS: The moderate information quality, scarce evidence base, constraints in data privacy and security features, and high volatility of SMAs pose challenges for users, health professionals, and researchers. However, owing to the scalability of SMAs and the few but promising results regarding their effectiveness, they have a high potential to reach and help a broad audience. For a holistic stress management approach, SMAs could benefit from a broader repertoire of strategies, such as more instrumental and mental stress management strategies. The common characteristics of SMAs with top-rated quality can be used as guidance for potential users and health professionals, but owing to the high volatility of SMAs, enhanced evaluation frameworks are needed.