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

NCT06532500 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-13

No results posted yet for this study

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

Conditions

  • Mood Disorders
  • Anxiety Disorders

Interventions

BEHAVIORAL

CBT-MyOWL

12-sessions of CBT-MyOWL

BEHAVIORAL

CBT-as-usual

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

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Mark Sinyor, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06532500 on ClinicalTrials.gov