NCT04010890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 4, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2022

Completed
Last Updated

April 27, 2026

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

July 1, 2019

Last Update Submit

April 22, 2026

Conditions

Keywords

culturecognitive therapyCanada

Outcome Measures

Primary Outcomes (1)

  • 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.

    36 weeks

Secondary Outcomes (2)

  • WHO DAS 2 (World Health Organization, Disability Assessment Scale, 2nd version)

    36 weeks

  • Bradford Somatic Inventory

    36 weeks

Study Arms (2)

Culturally adapted CBT

EXPERIMENTAL

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

Behavioral: Culturally adapted CBT

Standard CBT

ACTIVE COMPARATOR

Participants in this group will receive standard CBT

Behavioral: Culturally adapted CBT

Interventions

Culturally adapted CBT for South Asian Canadians

Also known as: CaCBT
Culturally adapted CBTStandard CBT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Somerset West Mental Health Services

Ottawa, Canada

Location

Punjabi Health

Toronto, Canada

Location

Moving Forward

Vancouver, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Bruce Pollock

    Center for Addiction and Mental Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, investigator and outcomes assessor were not informed of or aware of the allocation to intervention arm.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This mixed study will be conducted in 3 phases 1. Development of culturally adapted CBT for Canadian South Asians through a qualitative study 2. Testing culturally adapted CBT against standard CBT for efficacy through RCT and economic evaluation 3. Evaluation of training of therapists in culturally adapted CBT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 8, 2019

Study Start

June 4, 2021

Primary Completion

October 6, 2022

Study Completion

October 6, 2022

Last Updated

April 27, 2026

Record last verified: 2021-07

Locations