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

Recruiting · NCT06532500 · Interventional (participants receive a specific treatment) · Lead sponsor: Sunnybrook Health Sciences Centre

View the official record on ClinicalTrials.gov →

Anxiety

Interventions studied

CBT-MyOWLCBT-as-usual

What this trial is about

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

Who can take part

Age range

14 Years to 19 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed.

Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →