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

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

Study Overview

• Status: Recruiting
• Conditions: Mood Disorders; Anxiety Disorders
• Intervention / Treatment: Behavioral: CBT-MyOWL; Behavioral: CBT-as-usual

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prudence Chan, HBSc; Phone Number: 416-480-4070; Email: poming.chan@sri.utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Po Ming Prudence Chan, HBSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-MyOWL; A novel talk therapy model where we incorporate the standard CBT model with experiential learning while reading the third novel in the Harry Potter series to teach coping skills and emotional resiliency. The 12 sessions of CBT-MyOWL will follow a modestly adapted version of the intervention offered on www.myowl.org. The therapist will cover topics such as risk and protective factors for distress and mental health problems, cognitive distortions, cognitive reframing, fear hierarchies, behavioural activation and core beliefs while reading Harry Potter and the Prisoner of Azkaban.	Behavioral: CBT-MyOWL; 12-sessions of CBT-MyOWL
Active Comparator: CBT-as-usual; A talk therapy where participants will be encouraged to recognize distortions in thinking and then to reevaluate them in light of the evidence, gain a better understanding of how their behaviour contributes to wellbeing, learn to use problem-solving skills to cope with difficult situations, and learn to develop a greater sense of confidence in one's own abilities. This is the control group, and they will be utilizing the 'Mind over Mood' and/or the 'Anxiety and Phobia Workbook' according to the primary diagnosis.	Behavioral: CBT-as-usual; 12-sessions of CBT using Mind Over Mood or Anxiety Phobia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dropout rates	To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL / CBT-as-usual.	Comparing the baseline and across the 12 weeks
Acceptability Questionnaire	To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants.* *Note, given that CBT-as-usual is the gold standard treatment, we assume it will be feasible and acceptable and are mainly interested in the feasibility and acceptability of CBT-MyOWL. However, we believe it is important to measure both and will report on any differences identified.	12 week session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual.	Comparing the baseline and across the 12 weeks
Change from Baseline in Revised Children's Anxiety and Depression Scale score to weeks 3, 6, 9 and 12	The Revised Children's Anxiety and Depression Scale (RCADS) is a 25-item self-report designed to measure anxiety and depression. The total score of the RCADS-25 is calculated by assigning 0-3 to the response categories of "never", "sometimes", "often", "always", respectively. The sum of all 25 items is tallied and represents the severity of general anxiety and depressive symptoms. The minimum score is 0 and the maximum score is 75. Higher scores mean a worse outcome. Converted scores on the total scale and both sub-scales are divided into scoring ranges, where: (a) scores below 65 represent low severity, (b) scores between 65-70 represent medium severity and are on the borderline clinical threshold, and (c) scores above 70 represent high severity and are above the clinical threshold.	Baseline, Week 3, Week 6, Week 9 and Week 12
Change from Baseline in The Coping Scale for Children and Youth score to weeks 3, 6, 9 and 12	The Coping Scale for Children and Youth (CSCY) is a 29-item self-report designed to measure coping behaviours. The total score of the CSCY is calculated by assigning 0-3 to the response categories of "never", "sometimes", "often", and "very often", respectively. The minimum score is 0 and the maximum score is 29. Higher scores mean a better outcome.	Baseline, Week 3, Week 6, Week 9 and Week 12
Change from Baseline in The Cognitive and Behavioural Response to Stress Scale score to weeks 3, 6, 9 and 12	The Cognitive and Behavioural Response to Stress Scale (CB-RSS) is a 19-item self-report designed to measure cognitive and behavioural responses in a stressful situation. 0 = Never, 1 = Rarely, 2 = Occasionally, 3 = Sometimes, 4 = Often, 5 = Very often, 6 = Always. Higher scores means a better outcome.	Baseline, Week 3, Week 6, Week 9 and Week 12
Changes from Baseline in The Columbia-Suicide Severity Rating Scale score to weeks 3, 6, 9 and 12	The Columbia-Suicide Severity Rating Scale (CSSRS) is a 6-item research assistant/coordinator-rated questionnaire. Our research team also added one item on non-suicidal self-injurious behaviour. The outcome is measured by comparing the number of times the participants in the CBT-MyOWL versus the CBT-as-usual group answered yes/no to the self-harm behaviour question throughout the four times asked during the CBT.	Baseline, Week 3, Week 6, Week 9 and Week 12

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Mark Sinyor, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Mood Disorders
• Other Study ID Numbers: 6352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No