Recruiting

Cognitive Behavioural Therapy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06532500

Conditions

Mood Disorders

Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 14 - 19

Healthy Volunteers: Not accepted

Interventions

CBT-MyOWL

CBT-as-usual

Study Details

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. 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

Study ID

NCT06532500

Start date

Oct 24, 2024

Status verified date

May, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 19

Healthy Volunteers: Not accepted

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

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

CBT-MyOWL

12-sessions of CBT-MyOWL

CBT-as-usual

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

Primary outcome measure

  • Dropout rates [ Time Frame: Comparing the baseline and across the 12 weeks ]
  • Acceptability Questionnaire [ Time Frame: 12 week session ]

Central Contacts and Locations

Central contacts

Prudence Chan, HBSc

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

May 13, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-05-13.