- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03711344
Culturally Adapting CBT for East Asian Youth in Ontario
January 30, 2019 updated by: Centre for Addiction and Mental Health
Improving Access to High Quality, Culturally Relevant Treatment for East Asian Canadian Youth in Ontario
This mixed methods study proposes a culturally adapted cognitive behavioural therapy (CA-CBT) model for an East Asian demographic in Canada.
The client population of East Asian youth who have been diagnosed with anxiety and/or depression are the focus of the study.
CBT has been proven as a very effective form of therapy, and when adapted can promote positive mental health outcomes for a growing and increasingly vulnerable population.
Developing a culturally adapted version of CBT (CA-CBT) for this population adds a practical treatment that improves access to culturally relevant care.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
There is a major lack of culturally relevant mental health services for East Asian youth in Ontario and Canada.
Beginning with a participatory/qualitative research approach, common themes amongst clients, caregivers, healthcare professionals, and community leaders, will divulge basic elements needed to develop a culturally adapted model of cognitive behavioural therapy.
The information from the adapted model will be taught to participating psychologists who will deliver the therapy in a randomized control trial design, with feasibility testing of the intervention using a quantitative approach ensuing.
Immediate guidelines will then be developed for use by therapists working with East Asian youth.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Myra Levy
- Phone Number: 12243 416-438-3697
- Email: mlevy@emys.on.ca
Study Contact Backup
- Name: Sireesha Bobbili, MPH
- Phone Number: 36573 416-535-8501
- Email: Sireesha.Bobbili@camh.ca
Study Locations
-
-
Ontario
-
Scarborough, Ontario, Canada, M1H 3C3
- Recruiting
- East Metro Youth Services
-
Contact:
- Myra Levy
- Phone Number: 12243 4164383697
- Email: mlevy@emys.on.ca
-
Contact:
- Arlene GonashNelson
- Email: agonashnelson@emys.on.ca
-
Principal Investigator:
- Farooq Naeem, PhD/MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 21 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Self identification as East Asian origin
- Between the ages of 12 to 21
- Diagnosed as having depression and/or anxiety
Exclusion Criteria:
- Have been affected by psychosis
- Have been affected by serious addiction
- Have been affected by cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Culturally adapted Cognitive Behavioral therapy
The experimental group will receive the culturally adapted version of cognitive behavioral therapy.
|
The intervention will be administered by therapists working at community agencies who are experienced at providing Cognitive Behavioral Therapy.
|
ACTIVE_COMPARATOR: Non-adapted Cognitive Behavioral therapy
The control group will receive the original (non-adapted) version of cognitive behavioral therapy.
|
The intervention will be administered by therapists working at community agencies who are experienced at providing Cognitive Behavioral Therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity levels of depression and anxiety rated by the Hospital Anxiety and Depression Scale (HADS).
Time Frame: 4 months.
|
Severity levels of depression and anxiety will be rated pre- and post-intervention by the Hospital Anxiety and Depression Scale (HADS).
The scale ranges from 0 to 21 for anxiety and 0 to 21 for depression.
A score of 0 to 7 for depression and/or anxiety is considered a normal range.
A score of 8 to 10 suggests the potential presence of depression and/or anxiety.
A score of 11 or more suggests a likely presence of depression and/or anxiety.
|
4 months.
|
Severity levels of depression and anxiety rated by the Bradford Somatic Inventory (BSI).
Time Frame: 4 months.
|
Severity levels of depression and anxiety will be rated pre- and post-intervention by the Bradford Somatic Inventory (BSI).
The Bradford Somatic Inventory uses "yes" or "no" questions relating to somatic symptoms of anxiety and/or depression.
A "yes" response to a question equates to a somatic symptom linked to depression and/or anxiety.
The maximum number of "yes" responses is 46 and the minimum is 0. A higher number of "yes" responses suggests a potential increase in the severity of depression and/or anxiety.
|
4 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction of the culturally adapted Cognitive Behavioral Therapy assessed using the Verona Satisfaction Scale.
Time Frame: 4 months.
|
Satisfaction will be measured using the Verona Satisfaction Scale.
This scale measures patients satisfaction with health care services.
The items are rated by 4 categories labelled: "strongly disagree", "disagree", "agree", and "strongly agree", on a scale of 1 to 4. A higher sub-scale/domain score indicates better satisfaction.
All sub-scales are summed up to compute total/domain score.
This scale will be used to identify the strengths and weaknesses of the therapy service and provide guidance for further development.
|
4 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Farooq Naeem, M.D., Centre for Addiction and Mental Health
- Study Director: Myra Levy, M.A., East Metro Youth Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 4, 2019
Primary Completion (ANTICIPATED)
September 18, 2019
Study Completion (ANTICIPATED)
September 18, 2019
Study Registration Dates
First Submitted
September 11, 2018
First Submitted That Met QC Criteria
October 16, 2018
First Posted (ACTUAL)
October 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 1, 2019
Last Update Submitted That Met QC Criteria
January 30, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- innovation-1927
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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