RecruitingNot ApplicableNCT06532500

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


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

50 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 14 YearsMax Age: 19 Years

Inclusion Criteria4

  • 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 Criteria2

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

Interventions

BEHAVIORALCBT-MyOWL

12-sessions of CBT-MyOWL

BEHAVIORALCBT-as-usual

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


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT06532500


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