Search

IntroductionDigital cognitive behavioral therapy (i-CBT) interventions for the treatment of depression have been extensively studied and shown to be effective in the reduction of depressive symptoms. However, little is known about their effects on suicidal thoughts and behaviors (STB). Information on the impact of digital interventions on STB are essential for patients' safety because most digital interventions are self-help interventions without direct support options in case of a suicidal crisis. Therefore, we aim to conduct a meta-analysis of individual participant data (IPDMA) to investigate the effects of i-CBT interventions for depression on STB and to explore potential effect moderators.MethodsData will be retrieved from an established and annually updated IPD database of randomized controlled trials investigating the effectiveness of i-CBT interventions for depression in adults and adolescents. We will conduct a one-stage and a two-stage IPDMA on the effects of these interventions on STB. All types of control conditions are eligible. STB can be measured using specific scales (e.g., Beck scale suicide, BSS) or single items from depression scales (e.g., item 9 of the PHQ-9) or standardized clinical interviews. Multilevel linear regression will be used for specific scales, and multilevel logistic regression will be used for treatment response or deterioration, operationalized as a change in score by at least one quartile from baseline. Exploratory moderator analyses will be conducted at participant, study, and intervention level. Two independent reviewers will assess the risk of bias using the Cochrane Risk of Bias Tool 2.ConclusionThis IPDMA will harness the available data to assess the effects (response and deterioration) of i-CBT interventions for depression interventions on STB. Information about changes in STB is essential to estimate patients' safety when engaging in digital treatment formats.Trial registrationWe will pre-register this study with the open science framework after article acceptance to ensure consistency between online registration and the published trial protocol.

Introduction Digital cognitive behavioral therapy (i-CBT) interventions for the treatment of depression have been extensively studied and shown to be effective in the reduction of depressive symptoms. However, little is known about their effects on suicidal thoughts and behaviors (STB). Information on the impact of digital interventions on STB are essential for patients’ safety because most digital interventions are self-help interventions without direct support options in case of a suicidal crisis. Therefore, we aim to conduct a meta-analysis of individual participant data (IPDMA) to investigate the effects of i-CBT interventions for depression on STB and to explore potential effect moderators. Methods Data will be retrieved from an established and annually updated IPD database of randomized controlled trials investigating the effectiveness of i-CBT interventions for depression in adults and adolescents. We will conduct a one-stage and a two-stage IPDMA on the effects of these interventions on STB. All types of control conditions are eligible. STB can be measured using specific scales (e.g., Beck scale suicide, BSS) or single items from depression scales (e.g., item 9 of the PHQ-9) or standardized clinical interviews. Multilevel linear regression will be used for specific scales, and multilevel logistic regression will be used for treatment response or deterioration, operationalized as a change in score by at least one quartile from baseline. Exploratory moderator analyses will be conducted at participant, study, and intervention level. Two independent reviewers will assess the risk of bias using the Cochrane Risk of Bias Tool 2. Conclusion This IPDMA will harness the available data to assess the effects (response and deterioration) of i-CBT interventions for depression interventions on STB. Information about changes in STB is essential to estimate patients’ safety when engaging in digital treatment formats. Trial registration We will pre-register this study with the open science framework after article acceptance to ensure consistency between online registration and the published trial protocol.

BackgroundMobile health apps (MHA) have the potential to improve health care. The commercial MHA market is rapidly growing, but the content and quality of available MHA are unknown. Instruments for the assessment of the quality and content of MHA are highly needed. The Mobile Application Rating Scale (MARS) is one of the most widely used tools to evaluate the quality of MHA. Only few validation studies investigated its metric quality. No study has evaluated the construct validity and concurrent validity.ObjectiveThis study evaluates the construct validity, concurrent validity, reliability, and objectivity, of the MARS.MethodsData was pooled from 15 international app quality reviews to evaluate the metric properties of the MARS. The MARS measures app quality across four dimensions: engagement, functionality, aesthetics and information quality. Construct validity was evaluated by assessing related competing confirmatory models by confirmatory factor analysis (CFA). Non-centrality (RMSEA), incremental (CFI, TLI) and residual (SRMR) fit indices were used to evaluate the goodness of fit. As a measure of concurrent validity, the correlations to another quality assessment tool (ENLIGHT) were investigated. Reliability was determined using Omega. Objectivity was assessed by intra-class correlation.ResultsIn total, MARS ratings from 1,299 MHA covering 15 different health domains were included. Confirmatory factor analysis confirmed a bifactor model with a general factor and a factor for each dimension (RMSEA = 0.074, TLI = 0.922, CFI = 0.940, SRMR = 0.059). Reliability was good to excellent (Omega 0.79 to 0.93). Objectivity was high (ICC = 0.82). MARS correlated with ENLIGHT (psConclusionThe metric evaluation of the MARS demonstrated its suitability for the quality assessment. As such, the MARS could be used to make the quality of MHA transparent to health care stakeholders and patients. Future studies could extend the present findings by investigating the re-test reliability and predictive validity of the MARS.