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

NCT06532500 | Recruiting

• 1 other identifier: 6352
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual.
2. 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.

Conditions

Mood Disorders; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Retention

  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

  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

  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

  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

  Baseline, Week 3, Week 6, Week 9 and Week 12

Study Arms (2)

CBT-MyOWL

EXPERIMENTAL

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

CBT-as-usual

ACTIVE COMPARATOR

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

Interventions

CBT-MyOWL BEHAVIORAL

12-sessions of CBT-MyOWL

CBT-MyOWL

CBT-as-usual BEHAVIORAL

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

CBT-as-usual

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Mood Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mark Sinyor, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prudence Chan, HBSc

CONTACT

416-480-4070; poming.chan@sri.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Model Details: Participants have a 50/50 chance of being assigned to the CBT-MyOWL or CBT-as-usual group for 12 sessions of either therapy.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)