I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders
NCT Number: NCT06532500
Acronym: I-CARE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mood Disorders|Anxiety Disorders
Interventions: BEHAVIORAL: CBT-MyOWL|BEHAVIORAL: CBT-as-usual
Sponsor: Sunnybrook Health Sciences Centre
Sex: ALL
Age: CHILD, ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01

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

Primary Outcome Measures: 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 Outcome Measures: Retention, To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual., 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, The Revised Children's Anxiety and Depression Scale (RCADS) is a 25-item self-report designed to measure anxiety and depression.

The total score of the RCADS-25 is calculated by assigning 0-3 to the response categories of "never", "sometimes", "often", "always", respectively. The sum of all 25 items is tallied and represents the severity of general anxiety and depressive symptoms. The minimum score is 0 and the maximum score is 75. Higher scores mean a worse outcome.

Converted scores on the total scale and both sub-scales are divided into scoring ranges, where: (a) scores below 65 represent low severity, (b) scores between 65-70 represent medium severity and are on the borderline clinical threshold, and (c) scores above 70 represent high severity and are above the clinical threshold., 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, The Coping Scale for Children and Youth (CSCY) is a 29-item self-report designed to measure coping behaviours.

The total score of the CSCY is calculated by assigning 0-3 to the response categories of "never", "sometimes", "often", and "very often", respectively. The minimum score is 0 and the maximum score is 29. Higher scores mean a better outcome., 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, The Cognitive and Behavioural Response to Stress Scale (CB-RSS) is a 19-item self-report designed to measure cognitive and behavioural responses in a stressful situation. 0 = Never, 1 = Rarely, 2 = Occasionally, 3 = Sometimes, 4 = Often, 5 = Very often, 6 = Always. Higher scores means a better outcome., 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, The Columbia-Suicide Severity Rating Scale (CSSRS) is a 6-item research assistant/coordinator-rated questionnaire. Our research team also added one item on non-suicidal self-injurious behaviour. The outcome is measured by comparing the number of times the participants in the CBT-MyOWL versus the CBT-as-usual group answered yes/no to the self-harm behaviour question throughout the four times asked during the CBT., Baseline, Week 3, Week 6, Week 9 and Week 12