Mood DisordersI-CARENCT06532500
I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders
A study testing CBT-MyOWL and CBT-as-usual in people with Mood Disorders and Anxiety Disorders, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Mood Disorders, Anxiety Disorders
- What is being tested?
- CBT-MyOWL and CBT-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 24 Oct 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients already participating in active CBT therapy or recently completed CBT treatment (within the past 3 months)
- Active psychosis or mania
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Po Ming Prudence Chan, HBSc
About this study
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.
Read more
Primary Objective (acceptability): To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants.
Secondary Objectives:
- To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual.
- 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
- Conditions
- Mood Disorders, Anxiety Disorders
- Being tested
- CBT-MyOWL, CBT-as-usual
- Medical subject headings
- Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-MyOWLBehavioural
12-sessions of CBT-MyOWL
CBT-as-usualBehavioural
12-sessions of CBT using Mind Over Mood or Anxiety Phobia
| Study group | Role | What they receive |
|---|---|---|
| CBT-MyOWL | Experimental | 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. Receives: Behavioral: CBT-MyOWL |
| CBT-as-usual | Active comparator | 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. Receives: Behavioral: CBT-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dropout rates
To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL / CBT-as-usual.
Measured: Comparing the baseline and across the 12 weeks
Acceptability Questionnaire
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.
Measured: 12 week session
Secondary outcomes (5)
Retention
To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual.
Measured: Comparing the baseline and across the 12 weeks
Change from Baseline in Revised Children's Anxiety and Depression Scale score to weeks 3, 6, 9 and 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.
Measured: Baseline, Week 3, Week 6, Week 9 and Week 12
Change from Baseline in The Coping Scale for Children and Youth score to weeks 3, 6, 9 and 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.
Measured: Baseline, Week 3, Week 6, Week 9 and Week 12
Change from Baseline in The Cognitive and Behavioural Response to Stress Scale score to weeks 3, 6, 9 and 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.
Measured: Baseline, Week 3, Week 6, Week 9 and Week 12
Changes from Baseline in The Columbia-Suicide Severity Rating Scale score to weeks 3, 6, 9 and 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.
Measured: Baseline, Week 3, Week 6, Week 9 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start24 Oct 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Sinyor, Sunnybrook Health Sciences Centre
- Investigators
- Mark Sinyor, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532500
- Sponsor's protocol ID
- 6352
- Acronym
- I-CARE
- Status last verified
- May 2025
- First submitted
- 29 Jul 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders
- ClinicalTrials.gov ID
- NCT06532500
- Acronym / sponsor ID
- I-CARE / 6352
- Conditions
- Mood Disorders, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CBT-MyOWL | Experimental | Behavioral: CBT-MyOWLA 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. |
| CBT-as-usual | Active comparator | Behavioral: CBT-as-usualA 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients already participating in active CBT therapy or recently completed CBT treatment (within the past 3 months)
- Active psychosis or mania
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-MyOWL12-sessions of CBT-MyOWL | Behavioural | CBT-MyOWL |
| CBT-as-usual12-sessions of CBT using Mind Over Mood or Anxiety Phobia | Behavioural | CBT-as-usual |
Primary outcome
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.
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.
5 secondary outcomes
Retention
Time frame: Comparing the baseline and across the 12 weeks
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Sinyor, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-MyOWL and CBT-as-usual in people with Mood Disorders and Anxiety Disorders, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prudence Chan, HBSc (416-480-4070, poming.chan@sri.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dropout rates (time frame: Comparing the baseline and across the 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.