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

Sunnybrook Health Sciences Centre

Status: Enrolling

Conditions: Anxiety Disorders; Mood Disorders

Treatments: Behavioral: CBT-as-usual; Behavioral: CBT-MyOWL

Study type: Interventional

Funder types: Other

Identifiers

NCT06532500

6352

Details and patient eligibility

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

Enrollment: 50 estimated patients

Sex: All

Ages: 14 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

CBT-MyOWL

Experimental group

Description:

A novel talk therapy model where we incorporate the standard CBT model with experiential learning while reading the third novel in the Harry Potter series to teach coping skills and emotional resiliency. The 12 sessions of CBT-MyOWL will follow a modestly adapted version of the intervention offered on www.myowl.org. The therapist will cover topics such as risk and protective factors for distress and mental health problems, cognitive distortions, cognitive reframing, fear hierarchies, behavioural activation and core beliefs while reading Harry Potter and the Prisoner of Azkaban.

Treatment:

Behavioral: CBT-MyOWL

CBT-as-usual

Active Comparator group

Description:

A talk therapy where participants will be encouraged to recognize distortions in thinking and then to reevaluate them in light of the evidence, gain a better understanding of how their behaviour contributes to wellbeing, learn to use problem-solving skills to cope with difficult situations, and learn to develop a greater sense of confidence in one's own abilities. This is the control group, and they will be utilizing the 'Mind over Mood' and/or the 'Anxiety and Phobia Workbook' according to the primary diagnosis.

Treatment:

Behavioral: CBT-as-usual