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NCT Number: NCT06532500

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

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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Key information

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Po Ming Prudence Chan, HBSc

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-MyOWL

Behavioral

12-sessions of CBT-MyOWL

CBT-as-usual

Behavioral

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

Primary outcomes

  1. Dropout rates

    Time frame: Comparing the baseline and across the 12 weeks

    To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL / CBT-as-usual.

  2. Acceptability Questionnaire

    Time frame: 12 week session

    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.

Secondary outcomes

  1. Retention

    Time frame: Comparing the baseline and across the 12 weeks

    To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual.

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

    Time frame: Baseline, Week 3, Week 6, Week 9 and Week 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.

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

    Time frame: Baseline, Week 3, Week 6, Week 9 and Week 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.

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

    Time frame: Baseline, Week 3, Week 6, Week 9 and Week 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.

  5. Changes from Baseline in The Columbia-Suicide Severity Rating Scale score to weeks 3, 6, 9 and 12

    Time frame: Baseline, Week 3, Week 6, Week 9 and Week 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Prudence Chan, HBSc

CONTACT

[email protected]

416-480-4070

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Acronym: I-CARE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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