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RECRUITING
NCT06532500
NA

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

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

14 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-10-24

Completion Date

2027-09-01

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

BEHAVIORAL

CBT-MyOWL

12-sessions of CBT-MyOWL

BEHAVIORAL

CBT-as-usual

12-sessions of CBT using Mind Over Mood or Anxiety Phobia

Locations (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada