Effectiveness of an add-on guided internet-based emotion regulation training (E-TRAIN) in adolescents with depressive and/or anxiety disorders: study protocol for a multicenter randomized controlled trial.

BACKGROUND: During adolescence, depressive and anxiety disorders are among the most common mental health disorders. Both disorders tend to persist, are predictive for other mental disorders, and are associated with severe impairment in diverse areas. Although Cognitive Behavioral Therapy (CBT) has proven to be an effective treatment, a considerable number of adolescents do not respond to CBT and residual symptoms often remain. Therefore, it is of great importance to improve treatment outcomes for depressed and/or anxious adolescents. Dysfunctional emotion regulation appears to be a transdiagnostic factor in the development and maintenance of aforementioned disorders. Enhancing emotion regulation skills may therefore reduce symptom severity. In light of this, we developed a guided internet-based emotion regulation training (E-TRAIN) that will be added to CBT. This study aims to evaluate the effectiveness of E-TRAIN + CBT compared to CBT alone on depressive and anxiety outcomes among adolescents with depressive and/or anxiety disorder. METHODS: In this multicenter two-arm randomized controlled trial with parallel group design, we aim to include 138 adolescents, aged 13-19 years, referred for treatment and diagnosed with depressive and/or anxiety disorder. Participants will be allocated to either CBT or CBT + E-TRAIN. Assessments will take place at baseline, and at 3 (T1), 6 (T2) and 12 (T3) months after baseline. We will conduct multi-informant assessments: the adolescent, a parent/caregiver, and the CBT therapist will be asked to fill in questionnaires. The continuous primary outcome measure is self-reported depressive and anxiety symptoms at six months after baseline, measured with the RCADS25. Secondary outcome measures include anxiety or depression diagnosis based on a semi-structured clinical interview, emotion (dys) regulation, and parent-report measures of anxiety, depression and emotion (dys) regulation. DISCUSSION: This study is the first randomized controlled trial to examine the additional value of a guided internet-based emotion regulation training to regular CBT in adolescents with depressive and/or anxiety disorders. If this intervention is effective, it can be implemented in mental health care and improve treatment for these young people. TRIAL REGISTRATION: Registered on June 23, 2021 in The Netherlands Trial Register (NL9564). Retrospectively registered. Recruitment started in May 2021 and is ongoing.

Internet and Computer-Based Cognitive Behavioral Therapy for Anxiety and Depression in Adolescents and Young Adults: Systematic Review and Meta-Analysis.

BACKGROUND: Anxiety and depressive disorders are prevalent in adolescents and young adults. However, most young people with mental health problems do not receive treatment. Computerized cognitive behavior therapy (cCBT) may provide an accessible alternative to face-to-face treatment, but the evidence base in young people is limited. OBJECTIVE: The objective was to perform an up-to-date comprehensive systematic review and meta-analysis of the effectiveness of cCBT in treating anxiety and depression in adolescents and young adults compared with active treatment and passive controls. We aimed to examine posttreatment and follow-up effects and explore the moderators of treatment effects. METHODS: We conducted systematic searches in the following six electronic databases: PubMed, EMBASE, PsycINFO, CINAHL, Web of Science, and Cochrane Central Register of Controlled Trials. We included randomized controlled trials comparing cCBT with any control group in adolescents or young adults (age 12-25 years) with anxiety or depressive symptoms. The quality of included studies was assessed using the Cochrane risk-of-bias tool for randomized trials, version 2.0. Overall quality of evidence for each outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Posttreatment means and SDs were compared between intervention and control groups, and pooled effect sizes (Hedges g) were calculated. Random-effects meta-analyses were conducted using Comprehensive Meta-Analysis software. Subgroup analyses and meta-regression analyses were conducted to explore whether age, guidance level, and adherence rate were associated with treatment outcome. RESULTS: The search identified 7670 papers, of which 24 studies met the inclusion criteria. Most included studies (22/24) had a high risk of bias owing to self-report measures and/or inappropriate handling of missing data. Compared with passive controls, cCBT yielded small to medium posttreatment pooled effect sizes regarding depressive symptoms (g=0.51, 95% CI 0.30-0.72, number needed to treat [NNT]=3.55) and anxiety symptoms (g=0.44, 95% CI 0.23-0.65, NNT=4.10). cCBT yielded effects similar to those of active treatment controls regarding anxiety symptoms (g=0.04, 95% CI -0.23 to 0.31). For depressive symptoms, the nonsignificant pooled effect size favored active treatment controls (g=-0.70, 95% CI -1.51 to 0.11, P=.09), but heterogeneity was very high (I2=90.63%). No moderators of treatment effects were identified. At long-term follow-up, cCBT yielded a small pooled effect size regarding depressive symptoms compared with passive controls (g=0.27, 95% CI 0.09-0.45, NNT=6.58). No other follow-up effects were found; however, power was limited owing to the small number of studies. CONCLUSIONS: cCBT is beneficial for reducing posttreatment anxiety and depressive symptoms in adolescents and young adults compared with passive controls. Compared with active treatment controls, cCBT yielded similar effects regarding anxiety symptoms. Regarding depressive symptoms, however, the results remain unclear. More high-quality research involving active controls and long-term follow-up assessments is needed in this population. TRIAL REGISTRATION: PROSPERO CRD42019119725; https://tinyurl.com/y5acfgd9.