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Behavioral Intervention

Cognitive Behavioural Therapy for Mood and Anxiety Disorders (I-CARE Trial)

N/A

Recruiting

Led By Mark Sinyor, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Aged 14-19

* Primary diagnosis of a mood disorder or an anxiety disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 3, week 6, week 9 and week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a type of therapy called CBT-MyOWL can help young people with mood and anxiety disorders. The researchers want to find out if this therapy is doable, helps

Who is the study for?

This trial is for English-speaking teens aged 14-19 with a primary diagnosis of mood or anxiety disorder, who are considered by their physician to be suitable candidates for Cognitive Behavioural Therapy (CBT).

What is being tested?

The study compares two types of CBT: 'CBT-MyOWL', which includes literature-based therapy, and standard 'CBT-as-usual'. It checks if the new method keeps patients engaged longer and is well-received. Teens will attend 12 sessions and complete questionnaires.

What are the potential side effects?

Since this trial involves psychological therapy rather than medication, side effects may include emotional discomfort due to discussing personal issues but typically do not involve physical symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 14 and 19 years old.

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My primary diagnosis is a mood or anxiety disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 3, week 6, week 9 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 3, week 6, week 9 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 3, week 6, week 9 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability Questionnaire

Dropout rates

Secondary study objectives

Change from Baseline in Revised Children's Anxiety and Depression Scale score to weeks 3, 6, 9 and 12

Change from Baseline in The Cognitive and Behavioural Response to Stress Scale score to weeks 3, 6, 9 and 12

Change from Baseline in The Coping Scale for Children and Youth score to weeks 3, 6, 9 and 12

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CBT-MyOWLExperimental Treatment1 Intervention

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 II: CBT-as-usualActive Control1 Intervention

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.

0 / 2Eligibility criteria met