Clinical trial NCT06532500: I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders
Official title: I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mood Disorders
Anxiety Disorders
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants have a 50/50 chance of being assigned to the CBT-MyOWL or CBT-as-usual group for 12 sessions of either therapy.
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Dropout rates
timeFrame: Comparing the baseline and across the 12 weeks
measure: Acceptability Questionnaire
timeFrame: 12 week session
Secondary outcomes:
measure: Retention
timeFrame: Comparing the baseline and across the 12 weeks
measure: Change from Baseline in Revised Children's Anxiety and Depression Scale score to weeks 3, 6, 9 and 12
timeFrame: Baseline, Week 3, Week 6, Week 9 and Week 12
measure: Change from Baseline in The Coping Scale for Children and Youth score to weeks 3, 6, 9 and 12
timeFrame: Baseline, Week 3, Week 6, Week 9 and Week 12
measure: Change from Baseline in The Cognitive and Behavioural Response to Stress Scale score to weeks 3, 6, 9 and 12
timeFrame: Baseline, Week 3, Week 6, Week 9 and Week 12
measure: Changes from Baseline in The Columbia-Suicide Severity Rating Scale score to weeks 3, 6, 9 and 12
timeFrame: Baseline, Week 3, Week 6, Week 9 and Week 12
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Mark Sinyor, MD
role: PRINCIPAL_INVESTIGATOR
References: