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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-24

Study Completion Date

2027-09-01

Brief Summary

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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

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Detailed Description

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Conditions

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Mood Disorders Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT-MyOWL

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.

Group Type EXPERIMENTAL

CBT-MyOWL

Intervention Type BEHAVIORAL

12-sessions of CBT-MyOWL

CBT-as-usual

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.

Group Type ACTIVE_COMPARATOR

CBT-as-usual

Intervention Type BEHAVIORAL

12-sessions of CBT using Mind Over Mood or Anxiety Phobia

Interventions

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CBT-MyOWL

12-sessions of CBT-MyOWL

Intervention Type BEHAVIORAL

CBT-as-usual

12-sessions of CBT using Mind Over Mood or Anxiety Phobia

Intervention Type BEHAVIORAL

Eligibility Criteria

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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