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Development and Evaluation of Culturally Adapted CBT for South Asian Canadians (CaCBT)

Primary Purpose

Depression, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Culturally adapted CBT
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 Depression focused on measuring culture, cognitive therapy, Canada

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants, between the ages of 18 - 64
  2. who score 8 or more on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Or on Anxiety Subscale, will be included in the study.

Exclusion Criteria:

1Participants who are dependent on alcohol or drugs (using DSM V criteria) 2. Those with significant cognitive impairment (e.g. intellectual disability or dementia) 3. With active psychosis 4. Participants who have received CBT during the previous 12 months

Sites / Locations

  • Somerset West Mental Health ServicesRecruiting
  • Punjabi HealthRecruiting
  • Moving ForwardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Culturally adapted CBT

Standard CBT

Arm Description

Ca_CBT will be delivered to the experimental group using the newly developed manual . The intervention will be delivered over 8-12 sessions. The Control group will receive standard CBT

Participants in this group will receive standard CBT

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale
HADS is a 14-item, self-assessment scale designed to measure anxiety and depression. The maximum score is 21 for depression and 21 for anxiety. A score of 8 - 10 suggests the presence of the borderline cases, while a score of 11 - 21 indicates abnormal cases.

Secondary Outcome Measures

WHO DAS 2 (World Health Organization, Disability Assessment Scale, 2nd version)
This scale assesses disability due to physical and psychological problems and has been used extensively in various research settings.
Bradford Somatic Inventory
The Bradford Somatic Inventory (BSI) enquires about a wide range of somatic symptoms during the previous month and has 45 items. Scores above 21 indicate depression

Full Information

First Posted
July 1, 2019
Last Updated
July 26, 2021
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT04010890
Brief Title
Development and Evaluation of Culturally Adapted CBT for South Asian Canadians
Acronym
CaCBT
Official Title
Development and Evaluation of Culturally Adapted CBT to Improve Community Mental Health Services for Canadians of South Asian Origin
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 26, 2021 (Anticipated)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and 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
Yes

5. Study Description

Brief Summary
As CBT was developed for persons from North America and European background it needs to be adapted for persons from non-Western cultures. This mixed methods study proposes a culturally adapted Cognitive Behavioural Therapy (CA-CBT) model for Canadians of South Asian origin. Beginning with a participatory/qualitative research approach, common themes amongst individuals with depression and/or anxiety, 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 therapists who will deliver the therapy in a randomized control trial design, with feasibility testing of the intervention using a quantitative approach. Immediate guidelines will then be developed for use by therapists working with South Asian clients.
Detailed Description
Background and Significance: Canadians of South Asian (SA) origin, defined as individuals with ancestral ties to India, Pakistan, Bangladesh, Sri Lanka, Bhutan, Afghanistan, Maldives and Nepal, comprise the largest racialized group in Canada, amounting to 1.6 million individuals or 5% of the Canadian population and 32% of the Canadian Asian population. This makes them the largest visible minority group in Canada, comprising 25.6% of the visible minority population, followed by East Asian and African-Caribbean Canadians, respectively. The SA Canadians are disproportionately affected by high rates of anxiety and mood disorders, placing those immigrating to Canada at age 17 or younger at a significantly higher risk for this condition compared to immigrants from elsewhere who immigrated at the same age. The SA Canadians are disproportionately impacted by the social determinants of health, including unemployment, low income, language barriers, low education, low literacy and migration stress. These factors can negatively impact mental health and decrease access to care, thereby increasing mental health inequities. Compared to other ethnocultural groups, SA Canadians with a major depressive episode reported the highest proportion of unmet mental health care needs (48%) and the highest percentage of perceived barriers to the availability of mental health care(33%). Canadians who had a major depressive episode and identified as SA were 85% less likely to seek treatment than Canadians who had experienced the same illness but identified as white. The lower use of mental health services by SA Canadians highlights the inequities in access to appropriate care for these populations. The Mental Health Commission of Canada (MHCC) recommends improving Canadian mental health care to serve diverse populations with equitable, timely access to appropriate, effective, and evidence-based treatments that attend to unique sociocultural needs (Mental Health Commission of Canada, 2014). The MHCC Case for Diversity report further highlights the necessity for culturally and linguistically relevant services particularly for immigrant, refugee, ethnocultural and racialized populations, such as SA Canadians. In light of the new $5B targeted federal transfer to "improve access to mental health and addiction services and to structured psychotherapy" (Government of Canada, 2016) there is an opportunity to complement efforts to expand the access that adequately address the mental health needs of diverse Canadian populations. Cognitive Behavioural Therapy in its current form is not suitable for persons from the non-western cultural background. Culturally-adapted Cognitive Behavioural Therapy (Ca_CBT) is an evidence-based practice. CaCBT is more effective than standard CBT and can reduce dropouts from therapy compared with standard CBT. Thus CaCBT can increase access to mental health services and improve outcomes for immigrant, refugee, ethnocultural and racialized populations. Adapting CBT for growing SA populations in Canada will ensure equitable access to effective, culturally-appropriate interventions. Accordingly, this study proposes to develop and evaluate Ca_CBT for depression and anxiety among SA populations in Canada. Study Objectives: The primary objective of the study is to develop culturally adapted CBT for South Asian persons with depression and anxiety. Secondary objectives include; (a) testing CaCBT against standard CBT for efficacy and cost-effectiveness, and (b) to test whether training in culturally adapted CBT can improve therapist's cultural competence. Methods: This mixed methods study will be conducted in three phases: Phase 1: Cultural Adaptation of CBT Cultural adaptation of CBT for SA populations in Canada experiencing depression and anxiety using stakeholder consultations and qualitative methodology Phase 2: Pilot Feasibility Testing of Ca_CBT Pilot test the newly developed Ca_CBT for feasibility, acceptability and effectiveness via quantitative methodology and a randomized controlled trial Phase 3: Implementation & Evaluation of Ca_CBT Trained therapists working with SA populations to use Ca_CBT with their clients. Evaluate therapist competence in using Ca_CBT as well as client satisfaction with the newly developed therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
culture, cognitive therapy, Canada

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This mixed study will be conducted in 3 phases Development of culturally adapted CBT for Canadian South Asians through a qualitative study Testing culturally adapted CBT against standard CBT for efficacy through RCT and economic evaluation Evaluation of training of therapists in culturally adapted CBT
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Culturally adapted CBT
Arm Type
Experimental
Arm Description
Ca_CBT will be delivered to the experimental group using the newly developed manual . The intervention will be delivered over 8-12 sessions. The Control group will receive standard CBT
Arm Title
Standard CBT
Arm Type
Active Comparator
Arm Description
Participants in this group will receive standard CBT
Intervention Type
Behavioral
Intervention Name(s)
Culturally adapted CBT
Other Intervention Name(s)
CaCBT
Intervention Description
Culturally adapted CBT for South Asian Canadians
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
HADS is a 14-item, self-assessment scale designed to measure anxiety and depression. The maximum score is 21 for depression and 21 for anxiety. A score of 8 - 10 suggests the presence of the borderline cases, while a score of 11 - 21 indicates abnormal cases.
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
WHO DAS 2 (World Health Organization, Disability Assessment Scale, 2nd version)
Description
This scale assesses disability due to physical and psychological problems and has been used extensively in various research settings.
Time Frame
36 weeks
Title
Bradford Somatic Inventory
Description
The Bradford Somatic Inventory (BSI) enquires about a wide range of somatic symptoms during the previous month and has 45 items. Scores above 21 indicate depression
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants, between the ages of 18 - 64 who score 8 or more on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Or on Anxiety Subscale, will be included in the study. Exclusion Criteria: 1Participants who are dependent on alcohol or drugs (using DSM V criteria) 2. Those with significant cognitive impairment (e.g. intellectual disability or dementia) 3. With active psychosis 4. Participants who have received CBT during the previous 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farooq Naeem, PhD
Phone
+14165358501
Email
farooq.naeem@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Pollock
Organizational Affiliation
Center for Addiction and Mental Health
Official's Role
Study Chair
Facility Information:
Facility Name
Somerset West Mental Health Services
City
Ottawa
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azaad Kassam
Facility Name
Punjabi Health
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Puneet Dhillon
Facility Name
Moving Forward
City
Vancouver
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gary Thandi

12. IPD Sharing Statement

Citations:
PubMed Identifier
34488853
Citation
Naeem F, Tuck A, Mutta B, Dhillon P, Thandi G, Kassam A, Farah N, Ashraf A, Husain MI, Husain MO, Vasiliadis HM, Sanches M, Munshi T, Abbott M, Watters N, Kidd SA, Ayub M, McKenzie K. Protocol for a multi-phase, mixed methods study to develop and evaluate culturally adapted CBT to improve community mental health services for Canadians of south Asian origin. Trials. 2021 Sep 6;22(1):600. doi: 10.1186/s13063-021-05547-4.
Results Reference
derived

Learn more about this trial

Development and Evaluation of Culturally Adapted CBT for South Asian Canadians

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