Remote blended treatment for individuals with suicidal ideation: A single-arm proof-of-concept trial.

INTRODUCTION: New digital treatment formats may reduce barriers to treatment for individuals with suicidal ideation. This study aimed to investigate the feasibility of a remote blended care programme for this population, defined as acceptability, demand, practicality, adaptation, indications of efficacy and safety. METHODS: We conducted a mixed-methods single-arm trial for proof-of-concept. Participants were eligible if they were at least 18 years old, had sufficient German proficiency, a Beck Scale for Suicidal Ideation score ≥2, internet access and lived near the outpatient clinic. The treatment consisted of 12 sessions of cognitive-behavioural videotherapy combined with online modules over 6 weeks. RESULTS: We included 10 participants. All patients were satisfied with the treatment; most patients (80%) reported unpleasant memories resurfacing. All patients completed all therapy sessions and a mean of 13.7 modules (SD = 5.7); three patients switched to face-to-face treatment, in one case due to safety concerns. All patients and most therapists (83.3%) found the treatment overall practicable. Most patients (66.7%) and therapists (66.7%) considered remote treatment equivalent to face-to-face therapy. There were no serious adverse events. CONCLUSION: While promising, the results suggest changes to the programme might be needed, particularly for patients' safety. A controlled feasibility trial should investigate temporary deteriorations.

Blending Video Therapy and Digital Self-Help for Individuals With Suicidal Ideation: Intervention Design and a Qualitative Study Within the Development Process.

BACKGROUND: Digital formats have the potential to enhance accessibility to care for individuals with suicidal ideation. However, digital self-help interventions have faced limitations, including small effect sizes in reducing suicidal ideation, low adherence, and safety concerns. OBJECTIVE: Therefore, we aimed to develop a remote blended cognitive behavioral therapy intervention that specifically targets suicidal ideation by blending video therapy with web-based self-help modules. The objective of this paper is to describe the collaborative development process and the resulting intervention and treatment rationale. METHODS: First, we compiled intervention components from established treatment manuals designed for people with suicidal ideation or behavior, resulting in the development of 11 drafts of web-based modules. Second, we conducted a qualitative study, involving 5 licensed psychotherapists and 3 lay counselors specialized in individuals with suicidal ideation who reviewed these module drafts. Data were collected using the think-aloud method and semistructured interviews, and a qualitative content analysis was performed. The 4 a priori main categories of interest were blended care for individuals with suicidal ideation, contents of web-based modules, usability of modules, and layout. Subcategories emerged inductively from the interview transcripts. Finally, informed by previous treatment manuals and qualitative findings, we developed the remote blended treatment program. RESULTS: The participants suggested that therapists should thoroughly prepare the web-based therapy with patients to tailor the therapy to each individual's needs. Participants emphasized that the web-based modules should explain concepts in a simple manner, convey empathy and validation, and include reminders for the safety plan. In addition, participants highlighted the need for a simple navigation and layout. Taking these recommendations into account, we developed a fully remote blended cognitive behavioral therapy intervention comprising 12 video therapy sessions and up to 31 web-based modules. The treatment involves collaboratively developing a personalized treatment plan to address individual suicidal drivers. CONCLUSIONS: This remote treatment takes advantage of the high accessibility of digital formats while incorporating full sessions with a therapist. In a subsequent pilot trial, we will seek input from individuals with lived experience and therapists to test the feasibility of the treatment.

Effects of digital cognitive behavioral therapy for depression on suicidal thoughts and behavior: Protocol for a systematic review and meta-analysis of individual participant data.

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.

The Effects of Internet-Based Cognitive Behavioral Therapy for Suicidal Ideation or Behaviors on Depression, Anxiety, and Hopelessness in Individuals With Suicidal Ideation: Systematic Review and Meta-Analysis of Individual Participant Data.

BACKGROUND: Suicide is a global public health problem. Digital interventions are considered a low-threshold treatment option for people with suicidal ideation or behaviors. Internet-based cognitive behavioral therapy (iCBT) targeting suicidal ideation has demonstrated effectiveness in reducing suicidal ideation. However, suicidal ideation often is related to additional mental health problems, which should be addressed for optimal care. Yet, the effects of iCBT on related symptoms, such as depression, anxiety, and hopelessness, remain unclear. OBJECTIVE: We aimed to analyze whether digital interventions targeting suicidal ideation had an effect on related mental health symptoms (depression, anxiety, and hopelessness). METHODS: We systematically searched CENTRAL, PsycInfo, Embase, and PubMed for randomized controlled trials that investigated guided or unguided iCBT for suicidal ideation or behaviors. Participants reporting baseline suicidal ideation were eligible. Individual participant data (IPD) were collected from eligible trials. We conducted a 1-stage IPD meta-analysis on the effects on depression, anxiety, and hopelessness-analyzed as 2 indices: symptom severity and treatment response. RESULTS: We included IPD from 8 out of 9 eligible trials comprising 1980 participants with suicidal ideation. iCBT was associated with significant reductions in depression severity (b=-0.17; 95% CI -0.25 to -0.09; P<.001) and higher treatment response (ie, 50% reduction of depressive symptoms; b=0.36; 95% CI 0.12-0.60; P=.008) after treatment. We did not find significant effects on anxiety and hopelessness. CONCLUSIONS: iCBT for people with suicidal ideation revealed significant effects on depression outcomes but only minor or no effects on anxiety and hopelessness. Therefore, individuals with comorbid symptoms of anxiety or hopelessness may require additional treatment components to optimize care. Studies that monitor symptoms with higher temporal resolution and consider a broader spectrum of factors influencing suicidal ideation are needed to understand the complex interaction of suicidality and related mental health symptoms.

Digital cognitive-behavioural therapy to reduce suicidal ideation and behaviours: a systematic review and meta-analysis of individual participant data.

QUESTION: Digital interventions based on cognitive-behavioural therapy (iCBT) is associated with reductions in suicidal ideation. However, fine-grained analyses of effects and potential effect-moderating variables are missing. This study aimed to investigate the effectiveness of iCBT on suicidal ideation, effect moderators, effects on suicide attempts and predictors of adherence. STUDY SELECTION AND ANALYSIS: We systematically searched CENTRAL, PsycINFO, Embase and PubMed for randomised controlled trials that investigated iCBT for suicidal ideation or behaviours. Participants reporting baseline suicidal ideation were eligible. We conducted a one-stage individual participant data (IPD) meta-analysis. Suicidal ideation was the primary outcome, analysed as three indices: severity of suicidal ideation, reliable changes and treatment response. FINDINGS: We included IPD from nine out of ten eligible trials (2037 participants). iCBT showed significant reductions of suicidal ideation compared with control conditions across all indices (severity: b=-0.247, 95% CI -0.322 to -0.173; reliable changes: b=0.633, 95% CI 0.408 to 0.859; treatment response: b=0.606, 95% CI 0.410 to 0.801). In iCBT, the rate of reliable improvement was 40.5% (controls: 27.3%); the deterioration rate was 2.8% (controls: 5.1%). No participant-level moderator effects were identified. The effects on treatment response were higher for trials with waitlist-controls compared with active controls. There were insufficient data on suicide attempts. Human support and female gender predicted treatment adherence. The main source of potential bias was missing outcome data. CONCLUSIONS: The current evidence indicates that iCBT is effective in reducing suicidal ideation irrespective of age, gender and previous suicide attempts. Future studies should rigorously assess suicidal behaviour and drop-out reasons.

Passive Sensing in the Prediction of Suicidal Thoughts and Behaviors: Protocol for a Systematic Review.

BACKGROUND: Suicide is a severe public health problem, resulting in a high number of attempts and deaths each year. Early detection of suicidal thoughts and behaviors (STBs) is key to preventing attempts. We discuss passive sensing of digital and behavioral markers to enhance the detection and prediction of STBs. OBJECTIVE: The paper presents the protocol for a systematic review that aims to summarize existing research on passive sensing of STBs and evaluate whether the STB prediction can be improved using passive sensing compared to prior prediction models. METHODS: A systematic search will be conducted in the scientific databases MEDLINE, PubMed, Embase, PsycINFO, and Web of Science. Eligible studies need to investigate any passive sensor data from smartphones or wearables to predict STBs. The predictive value of passive sensing will be the primary outcome. The practical implications and feasibility of the studies will be considered as secondary outcomes. Study quality will be assessed using the Prediction Model Risk of Bias Assessment Tool (PROBAST). If studies are sufficiently homogenous, we will conduct a meta-analysis of the predictive value of passive sensing on STBs. RESULTS: The review process started in July 2022 with data extraction in September 2022. Results are expected in December 2022. CONCLUSIONS: Despite intensive research efforts, the ability to predict STBs is little better than chance. This systematic review will contribute to our understanding of the potential of passive sensing to improve STB prediction. Future research will be stimulated since gaps in the current literature will be identified and promising next steps toward clinical implementation will be outlined. TRIAL REGISTRATION: OSF Registries osf-registrations-hzxua-v1; https://osf.io/hzxua. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42146.

Unveiling mechanisms of change in digital interventions for depression: Study protocol for a systematic review and individual participant data meta-analysis.

Introduction: The efficacy and effectiveness of digital interventions for depression are both well-established. However, precise effect size estimates for mediators transmitting the effects of digital interventions are not available; and integrative insights on the specific mechanisms of change in internet- and mobile-based interventions (IMIs)-as related to key features like delivery type, accompanying support and theoretical foundation-are largely pending. Objective: We will conduct a systematic review and individual participant data meta-analysis (IPD-MA) evaluating the mediators associated with therapeutic change in various IMIs for depression in adults. Methods: We will use three electronic databases (i.e., Embase, Medline/PubMed, PsycINFO) as well as an already established database of IPD to identify relevant published and unpublished studies. We will include (1) randomized controlled trials that examine (2) mediators of (3) guided and unguided (4) IMIs with (5) various theoretical orientations for (6) adults with (7) clinically relevant symptoms of depression (8) compared to an active or passive control condition (9) with depression symptom severity as primary outcome. Study selection, data extraction, as well as quality and risk of bias (RoB) assessment will be done independently by two reviewers. Corresponding authors of eligible primary studies will be invited to share their IPD for this meta-analytic study. In a 1-stage IPD-MA, mediation analyses (e.g., on potential mediators like self-efficacy, emotion regulation or problem solving) will be performed using a multilevel structural equation modeling approach within a random-effects framework. Indirect effects will be estimated, with multiple imputation for missing data; the overall model fit will be evaluated and statistical heterogeneity will be assessed. Furthermore, we will investigate if indirect effects are moderated by different variables on participant- (e.g., age, sex/gender, symptom severity), study- (e.g., quality, studies evaluating the temporal ordering of changes in mediators and outcomes), and intervention-level (e.g., theoretical foundation, delivery type, guidance). Discussion: This systematic review and IPD-MA will generate comprehensive information on the differential strength of mediators and associated therapeutic processes in digital interventions for depression. The findings might contribute to the empirically-informed advancement of psychotherapeutic interventions, leading to more effective interventions and improved treatment outcomes in digital mental health. Besides, with our novel approach to mediation analyses with IPD-MA, we might also add to a methodological progression of evidence-synthesis in psychotherapy process research. Study registration with Open Science Framework OSF: https://osf.io/md7pq/.

A Systematic Evaluation of Mobile Health Applications for the Prevention of Suicidal Behavior or Non-suicidal Self-injury.

People with suicidal ideation and non-suicidal self-injury (NSSI) behavior face numerous barriers to help-seeking, which worsened during the COVID-19 pandemic. Mobile health applications (MHA) are discussed as one solution to improve healthcare. However, the commercial app markets are growing unregulated and rapidly, leading to an inscrutable market. This study evaluates the quality, features, functions, and prevention strategies of MHA for people with suicidal ideation and NSSI. An automatic search engine identified MHA for suicidal behavior and NSSI in the European commercial app stores. MHA quality and general characteristics were assessed using the Mobile Application Rating Scale (MARS). MHA of high quality (top 25%) were examined in detail and checked for consistency with established suicide prevention strategies. Of 10,274 identified apps, 179 MHA met the predefined inclusion criteria. Average MHA quality was moderate (M = 3.56, SD = 0.40). Most MHA provided emergency contact, but lacked security features. High-quality MHA were broadly consistent with the best-practice guidelines. The search revealed apps containing potentially harmful and triggering content, and no randomized controlled trial of any included MHA was found. Despite a large heterogeneity in the quality of MHA, high-quality MHA for suicidal behavior and NSSI are available in European commercial app stores. However, a lack of a scientific evidence base poses potential threats to users.

Effectiveness of Internet- and Mobile-Based Cognitive Behavioral Therapy to Reduce Suicidal Ideation and Behaviors: Protocol for a Systematic Review and Meta-Analysis of Individual Participant Data.

Internet- and mobile-based cognitive behavioral therapy (iCBT) might reduce suicidal ideation. However, recent meta-analyses found small effect sizes, and it remains unclear whether specific subgroups of participants experience beneficial or harmful effects. This is the study protocol for an individual participant meta-analysis (IPD-MA) aiming to determine the effectiveness of iCBT on suicidal ideation and identify moderators. We will systematically search CENTRAL, PsycINFO, Embase, and Pubmed for randomized controlled trials examining guided or self-guided iCBT for suicidality. All types of control conditions are eligible. Participants experiencing suicidal ideation will be included irrespective of age, diagnoses, or co-interventions. We will conduct a one-stage IPD-MA with suicidal ideation as the primary outcome, using a continuous measure, reliable improvement and deterioration, and response rate. Moderator analyses will be performed on participant-, study-, and intervention-level. Two independent reviewers will assess risk of bias and the quality of evidence using Cochrane's Risk of Bias Tool 2 and GRADE. This review was registered with OSF and is currently in progress. The IPD-MA will provide effect estimates while considering covariates and will offer novel insights into differential effects on a participant level. This will help to develop more effective, safe, and tailored digital treatment options for suicidal individuals.

Internet-Based Cognitive Behavioral Therapy to Reduce Suicidal Ideation: A Systematic Review and Meta-analysis.

Importance: Suicidal ideation is a widespread phenomenon. However, many individuals at risk for suicide do not seek treatment, which might be addressed by providing low-threshold, internet-based self-help interventions. Objective: To investigate whether internet-based self-help interventions directly targeting suicidal ideation or behavior are associated with reductions in suicidal ideation. Data Sources: A systematic search of PsycINFO, MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and the Centre for Research Excellence of Suicide Prevention (CRESP) databases for trials from inception to April 6, 2019, was performed, supplemented by reference searches. Search strings consisted of various search terms related to the concepts of internet, suicide, and randomized clinical trials. Study Selection: Two independent researchers reviewed titles, abstracts, and full texts. Randomized clinical trials evaluating the effectiveness of internet-based self-help interventions to reduce suicidal ideation were included. Interventions were eligible if they were based on psychotherapeutic elements. Trials had to report a quantitative measure of a suicide-specific outcome. Mobile-based and gatekeeper interventions were excluded; no further restrictions were placed on participant characteristics or date of publication. Data Extraction and Synthesis: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Risk of bias was evaluated using the Cochrane Risk of Bias Tool. Standardized mean differences were calculated using a random-effects model. Main Outcomes and Measures: Suicidal ideation was the a priori primary outcome. Results: Six unique eligible trials (1567 unique participants; 1046 [66.8%] female; pooled mean [SD] age, 36.2 [12.5] years) were included in the systematic review and meta-analysis. All identified interventions were internet-based cognitive behavioral therapy (iCBT). Participants assigned to the iCBT condition experienced a significantly reduced suicidal ideation compared with controls following intervention in all 6 trials (standardized mean difference, -0.29; 95% CI, -0.40 to -0.19; P < .001). Heterogeneity was low (I2 = 0%). The effect appeared to be maintained at follow-up in 4 trials (standardized mean difference, -0.18; 95% CI, -0.34 to -0.02; P = .03; I2 = 36%). Studies did not report sufficient data on completed suicides and suicide attempts to assess potential associations. Conclusions and Relevance: These results show that iCBT interventions are associated with significant reductions in suicidal ideation compared with control conditions. Considering their high scalability, iCBT interventions have the potential to reduce suicide mortality. Future research should assess the effect of these digital health interventions on suicidal behavior and identify moderators and mediators to advance understanding of the mechanisms of effectiveness of these interventions.

The Effectiveness of Internet-Based Self-Help Interventions to Reduce Suicidal Ideation: Protocol for a Systematic Review and Meta-Analysis.

BACKGROUND: Suicidal ideation is a highly prevalent condition. There are several barriers for individuals to seek treatment that may be addressed by providing internet-based self-help interventions (ISIs). Current evidence suggests that ISIs for mental disorders may only be effective in reducing suicidal ideation if they specifically target suicidal thoughts or behaviors. OBJECTIVE: The aim of this systematic review and meta-analysis is to investigate the effectiveness of ISIs that directly target suicidal thoughts or behaviors. METHODS: We will conduct a sensitive systematic literature search in PsycINFO, MEDLINE, the Cochrane Central Register of Controlled Trials, and the Centre for Research Excellence of Suicide Prevention databases. Only randomized controlled trials evaluating the effectiveness of ISIs for suicide prevention will be included. Interventions must be delivered primarily in a Web-based setting; mobile-based interventions and interventions targeting gatekeepers will be excluded. Suicide ideation will be the primary outcome; secondary outcomes will be completed suicides, suicide attempts, depressiveness, anxiety, and hopelessness. Study quality will be assessed using the Cochrane Risk of Bias tool. We will provide a narrative synthesis of included studies. If studies are sufficiently homogenous, we will conduct a meta-analysis of the effectiveness on suicide ideation and, if possible, we will evaluate publication bias using funnel plots. We will evaluate the cumulative evidence in accordance with the Grading of Recommendations Assessment, Development and Evaluation framework. RESULTS: This review is in progress, with findings expected by August 2019. CONCLUSIONS: This systematic review and meta-analysis focuses on the effectiveness of ISIs for suicidal thoughts and behaviors. It will provide guidance to clinical practice and encourage further research by synthesizing the best available evidence. TRIAL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019130253; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=130253. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/14174.