I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CBT-MyOWL, CBT-as-usual.
- Who it may be relevant to
- Registry conditions: Mood Disorders, Anxiety Disorders. Basic parameters: 14 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Behavioral CBT-MyOWL
12-sessions of CBT-MyOWL - Behavioral CBT-as-usual
12-sessions of CBT using Mind Over Mood or Anxiety Phobia
Primary outcome measures
- Dropout rates [Time frame: Comparing the baseline and across the 12 weeks]
- Acceptability Questionnaire [Time frame: 12 week session]
Secondary outcome measures (5)
- Retention [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline, Week 3, Week 6, Week 9 and Week 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Sunnybrook Health Sciences Centre — Toronto
Identifiers
NCT: NCT06532500 · 6352