I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders

What this study is about

The goal of this clinical trial is to learn if CBT(Cognitive Behavioural Therapy)-MyOWL(Optimizing Wellness through Literature) is feasible, leads to better patient retention, and has high acceptability by youth psychiatric outpatients with mood and/or anxiety disorder aged 14-19. The main questions it aims to answer are: Primary Objective (feasibility): To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL / CBT-as-usual. Primary Objective (acceptability): To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants. Secondary Objectives: 1. To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual. 2. To determine whether youth who receive CBT-MyOWL have improved scores on all of the following over the course of treatment and endpoint compared to youth who receive CBT-as usual: i) depression and anxiety ii) suicidal ideation, iii) self-harm, and iv) coping and emotional resiliency. Participants will: Participate in 12 sessions of either CBT-MyOWL or CBT-as-usual (active control) Completes 4-5 questionnaires at sessions 3,6,9,12 Complete the acceptability and exit interview at session 12

Who can join (things the study team will check)

✅ You may be able to join if…

• Aged 14-19
• Primary diagnosis of a mood disorder or an anxiety disorder
• Ability to understand written and spoken English and to read a novel
• Treating physician considers CBT as indicated for the patient

🚫 You may not be able to join if…

• Patients already participating in active CBT therapy or recently completed CBT treatment (within the past 3 months)
• Active psychosis or mania

Where this trial is running

• Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Who to contact

Prudence Chan, HBSc · 416-480-4070 · poming.chan@sri.utoronto.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06532500.