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-based emotion-regulation training added to CBT in adolescents with depressive and anxiety disorders: A pilot randomized controlled trial to examine feasibility, acceptability, and preliminary effectiveness.

Background: Dysfunctional emotion regulation (ER) is associated with symptoms of depression and anxiety in adolescents. This pilot study aimed to examine the acceptability and feasibility of a guided internet-based emotion regulation training (ERT) added to cognitive behavioral therapy (CBT). Furthermore, we aimed to examine the feasibility of the randomized study design and to provide a first estimate of the effectiveness of CBT + ERT compared with CBT alone in adolescents with depressive or anxiety disorders. Methods: In a pilot randomized controlled trial (RCT) with a parallel group design, 39 patients (13-18 years) with depressive or anxiety disorder were assigned to CBT + ERT (n = 21) or CBT (n = 18). Assessments at baseline, three-months and six-months follow-up included treatment adherence, satisfaction, depressive symptoms, anxiety symptoms, and ER strategies. Results: Adherence to ERT was 66.5 %, and treatment satisfaction was adequate. 76.5 % of eligible patients participated in the study. Linear mixed-model analyses showed significantly reduced anxiety symptoms (p = .003), depressive symptoms (p = .017), and maladaptive ER (p = .014), and enhanced adaptive ER (p = .008) at six months follow-up in the CBT + ERT group compared to controls. Limitations: The sample size was small, and results regarding effectiveness remain preliminary. Data-collection took place during COVID-19, which may have influenced the results. Conclusions: Both the intervention and the study design were found to be feasible. In a larger RCT, however, improvement of recruitment strategy is necessary. Preliminary results indicate potential effectiveness in decreasing anxiety, depression, and emotion dysregulation in adolescents. The next step should be the development of an improved internet-based ERT and its evaluation in a larger RCT. Trial registration: Registered on January 14th, 2020 in The Netherlands Trial Register (NL8304).