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Culturally Adapting CBT for East Asian Youth in Ontario

Primary Purpose

Anxiety, Depression

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Cognitive Behavioral Therapy, Cultural Adaptation, East Asian Youth

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East Metro Youth ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Culturally adapted Cognitive Behavioral therapy

Non-adapted Cognitive Behavioral therapy

Arm Description

The experimental group will receive the culturally adapted version of cognitive behavioral therapy.

The control group will receive the original (non-adapted) version of cognitive behavioral therapy.

Outcomes

Primary Outcome Measures

Severity levels of depression and anxiety rated by the Hospital Anxiety and Depression Scale (HADS).
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.
Severity levels of depression and anxiety rated by the Bradford Somatic Inventory (BSI).
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.

Secondary Outcome Measures

Satisfaction of the culturally adapted Cognitive Behavioral Therapy assessed using the Verona Satisfaction Scale.
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.

Full Information

First Posted
September 11, 2018
Last Updated
January 30, 2019
Sponsor
Centre for Addiction and Mental Health
Collaborators
East Metro Youth Services, Hong Fook Mental Health Association, Ontario Centre of Excellence for Child and Youth Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT03711344
Brief Title
Culturally Adapting CBT for East Asian Youth in Ontario
Official Title
Improving Access to High Quality, Culturally Relevant Treatment for East Asian Canadian Youth in Ontario
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
September 18, 2019 (Anticipated)
Study Completion Date
September 18, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
East Metro Youth Services, Hong Fook Mental Health Association, Ontario Centre of Excellence for Child and Youth Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
Cognitive Behavioral Therapy, Cultural Adaptation, East Asian Youth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
East Asian youth diagnosed with Anxiety and/or depression will be randomly assigned to either the experimental group (receives the cultural adapted version of cognitive behavioral therapy) or the control group (non-culturally adapted cognitive behavioral therapy). It is a randomized control trial design.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Culturally adapted Cognitive Behavioral therapy
Arm Type
Experimental
Arm Description
The experimental group will receive the culturally adapted version of cognitive behavioral therapy.
Arm Title
Non-adapted Cognitive Behavioral therapy
Arm Type
Active Comparator
Arm Description
The control group will receive the original (non-adapted) version of cognitive behavioral therapy.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
The intervention will be administered by therapists working at community agencies who are experienced at providing Cognitive Behavioral Therapy.
Primary Outcome Measure Information:
Title
Severity levels of depression and anxiety rated by the Hospital Anxiety and Depression Scale (HADS).
Description
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.
Time Frame
4 months.
Title
Severity levels of depression and anxiety rated by the Bradford Somatic Inventory (BSI).
Description
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.
Time Frame
4 months.
Secondary Outcome Measure Information:
Title
Satisfaction of the culturally adapted Cognitive Behavioral Therapy assessed using the Verona Satisfaction Scale.
Description
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.
Time Frame
4 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myra Levy
Phone
416-438-3697
Ext
12243
Email
mlevy@emys.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sireesha Bobbili, MPH
Phone
416-535-8501
Ext
36573
Email
Sireesha.Bobbili@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farooq Naeem, M.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myra Levy, M.A.
Organizational Affiliation
East Metro Youth Services
Official's Role
Study Director
Facility Information:
Facility Name
East Metro Youth Services
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1H 3C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myra Levy
Phone
4164383697
Ext
12243
Email
mlevy@emys.on.ca
First Name & Middle Initial & Last Name & Degree
Arlene GonashNelson
Email
agonashnelson@emys.on.ca
First Name & Middle Initial & Last Name & Degree
Farooq Naeem, PhD/MD

12. IPD Sharing Statement

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Culturally Adapting CBT for East Asian Youth in Ontario

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