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I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders
NCT06532500 · Sunnybrook Health Sciences Centre
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patients already participating in active CBT therapy or recently completed CBT treatment (within the past 3 months)
* Active psychosis or mania
Study design
Enrollment target: 50 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2024-10-24
Estimated completion: 2027-09-01
Last updated: 2025-05-13
Interventions
Behavioral: CBT-MyOWLBehavioral: CBT-as-usual
Primary outcomes
- • Dropout rates (Comparing the baseline and across the 12 weeks)
- • Acceptability Questionnaire (12 week session)
Sponsor
Sunnybrook Health Sciences Centre · other
Contacts & investigators
ContactPrudence Chan, HBSc · contact · poming.chan@sri.utoronto.ca · 416-480-4070
InvestigatorMark Sinyor, MD · principal_investigator, Sunnybrook Health Sciences Centre
All locations (1)
Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada