Efficacy and Cost-effectiveness of Internet-delivered CBT for Adolescents With Depression — IDA  

Major Depressive Disorder Clinical Trial

Official title: Efficacy and Cost-effectiveness of Internet-delivered Cognitive Behavior Therapy for Adolescents With Mild to Moderate Depression: A Randomized Controlled Trial of Guided and Self-guided ICBT vs. Treatment as Usual

Status Recruiting

Clinical Trial Summary

Adolescent depression is a prevalent and impairing condition that can be effectively treated with Cognitive Behavior Therapy (CBT). However, a majority of adolescents do not have access to CBT. Internet-delivered CBT (ICBT) has been suggested as a way to increase availability to effective psychological treatments. Yet, the research on ICBT for adolescents has been lagging behind significantly. The overall aim of this research project is to increase the availability of evidence-based psychological treatments for adolescents with depression by developing and evaluating internet-delivered Cognitive Behavior Therapy (ICBT) for this target group. The main objectives are to establish the efficacy, cost-effectiveness, and long-term effects of the guided and self-guided ICBT for adolescents with mild to moderate depression in a randomized controlled trial (RCT) with three-arms; guided ICBT (with therapist-support) and self-guided ICBT (without therapist-support) vs treatment as usual (TAU).

Clinical Trial Description

Primary and secondary objectives Primary objective: 1. To determine the clinical efficacy of Guided and Self-guided ICBT for depression for reducing depressive symptom severity (as measured by the CDRS-R (27) in adolescents with mild and moderate major depressive disorder (MDD), compared with an active control intervention (treatment as usual within primary or secondary child and adolescent mental health care). The primary endpoint is the follow-up 3 months post-treatment. Secondary objectives: 1. To establish the 12-month durability of the treatment effects. 2. To conduct a health-economic evaluation of guided ICBT for depression and self-guided ICBT for depression, compared with TAU, from multiple perspectives, both in the short term (primary endpoint) and the long term (12-month follow-up). Research questions: 1. Is guided and self-guided ICBT more efficacious than TAU in regard to the reduction of depressive symptoms? 2. Is guided and self-guided ICBT more cost-effective than TAU? 3. Is self-guided ICBT more cost-effective than guided ICBT? 4. Are the therapeutic gains of ICBT maintained long term (i.e., 1 year after the intervention)? ;

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT04977856
• Study type: Interventional
• Source: Region Stockholm
• Contact: Eva Serlachius, PhD
• Phone: +467070155232
• Email: eva.serlachius@ki.se
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Completion date: August 31, 2025