Randomised controlled trial to compare the efficacy of integrated cognitive-behavioural therapy (COPE-A) for substance use and traumatic stress among adolescents and young adults delivered via telehealth versus in person: trial protocol.

Abstract

Emerging research indicates that integrated treatment of co-occurring post-traumatic stress disorder (PTSD) and substance use disorder can be effective among adolescents and young people. However, various barriers exist to young people accessing evidence-based treatments. Telehealth offers an opportunity to address these barriers and provide a scalable and accessible alternative to inperson treatment. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy, safety and cost-effectiveness of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents and young adults (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure - Adolescent and Young Adult version (COPE-A)) when delivered in person compared with via telehealth. A two-arm, parallel group, single-blind, non-inferiority RCT with follow-up at 4 months and 12 months post study entry will be conducted in Sydney, Australia. Participants (170 adolescents and young adults aged 12-25 years) will be allocated to receive COPE-A either in person or via telehealth (allocation ratio 1:1) using minimisation. Project psychologists will administer treatment via both modes of delivery over a maximum of 16 sessions of 60-90 min. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. This study has been approved by the Sydney Children's Hospitals Network Human Research Ethics Committee (2024/ETH01050). Research findings will be published in peer-reviewed journals and presented at scientific conferences. ACTRN12624000776505. V.2.3, 20 March 2025.