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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010890
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Farooq Naeem, Centre for Addiction and Mental Health

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.There is evidence that This mixed methods study proposes a culturally adapted Cognitive Behavioural Therapy (CA-CBT) model for an East Asian demographic in Toronto and Canada. Since the majority of the East Asian population in Toronto is of Chinese origin, the study will focus on this group. The client population of East Asian youth who have been diagnosed with anxiety and/or depression are the focus of the study. 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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Behavioral: Culturally adapted CBT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Evaluation of Culturally Adapted CBT to Improve Community Mental Health Services for Canadians of South Asian Origin
Estimated Study Start Date : July 3, 2019
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Culturally adapted CBT
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
Culturally adapted CBT for South Asian Canadians
Other Name: CaCBT

Active Comparator: Standard CBT
Participants in this group will receive standard CBT
Behavioral: Culturally adapted CBT
Culturally adapted CBT for South Asian Canadians
Other Name: CaCBT




Primary Outcome Measures :
  1. Hospital Anxiety and Depression Scale [ Time Frame: 36 weeks ]
    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 :
  1. WHO DAS 2 (World Health Organization, Disability Assessment Scale, 2nd version) [ Time Frame: 36 weeks ]
    This scale assesses disability due to physical and psychological problems and has been used extensively in various research settings.

  2. Bradford Somatic Inventory [ Time Frame: 36 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010890


Contacts
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Contact: Farooq Naeem, PhD +14165358501 farooq.naeem@camh.ca

Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Study Chair: Bruce Pollock Center for Addiction and Mental Health
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Responsible Party: Farooq Naeem, Professor, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04010890    
Other Study ID Numbers: CAddictionMH
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Farooq Naeem, Centre for Addiction and Mental Health:
culture
cognitive therapy
Canada
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms