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DepressionCaCBTNCT04010890

Development and Evaluation of Culturally Adapted CBT for South Asian Canadians

A study testing Culturally adapted CBT in people with Depression and Anxiety, run by Centre for Addiction and Mental Health at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression, Anxiety
What is being tested?
Culturally adapted CBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
3 sitesCanada
Study dates
4 Jun 2021to 6 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites
  • Somerset West Mental Health Services

    Ottawa

  • Punjabi Health

    Toronto

  • Moving Forward

    Vancouver

Other trials in Canada

About this study

Official title: Development and Evaluation of Culturally Adapted CBT to Improve Community Mental Health Services for Canadians of South Asian Origin

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.

Read the 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.

Conditions
Depression, Anxiety
Being tested
Culturally adapted CBT
Keywords
culture, cognitive therapy, Canada
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Culturally adapted CBTBehavioural

    Also called CaCBT

    Culturally adapted CBT for South Asian Canadians

Study groups in NCT04010890
Study groupRoleWhat they receive
Culturally adapted CBTExperimentalCa_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
Receives: Behavioral: Culturally adapted CBT
Standard CBTActive comparatorParticipants in this group will receive standard CBT
Receives: Behavioral: Culturally adapted CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 36 weeks

Secondary outcomes (2)
  1. 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.

    Measured: 36 weeks

  2. 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

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2019
  2. Study start4 Jun 2021
  3. Primary completion6 Oct 2022
  4. Study completion6 Oct 2022

Resources

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
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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04010890
Sponsor's protocol ID
CAddictionMH
Acronym
CaCBT
Status last verified
Jul 2021
First submitted
1 Jul 2019
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34488853

Questions about this trial

What is this clinical trial studying?

A study testing Culturally adapted CBT in people with Depression and Anxiety, run by Centre for Addiction and Mental Health at 3 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Anxiety and Depression Scale (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04010890, which also lists 1 linked publication.

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 27 Apr 2026.

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