- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01239407
Culturally-focused Consultation for Asian Americans and Latino Americans (CFP)
Culturally Focused Psychiatric Consultation Service for Asian American and Latino American Primary Care Patients With Depression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study's aim is to determine if a culturally focused mental health consultation will help Latino and Asian Americans who are experiencing sadness, stress, or other symptoms of depression. Eligible adults must already have a primary care physician at Massachusetts General Hospital.
In this study, patients will be randomly assigned, like the flip of a coin, to receive the culturally focused intervention or treatment as usual. Those who receive the intervention will have three sessions with study personnel, during which they will generally discuss and learn techniques for dealing with their mental health. Those who receive treatment as usual, meaning the regular care they receive through their primary care practice, will have two sessions with study personnel during which they will generally discuss their mental health. All study visits and patient materials are provided in patients' language of choice - English, Spanish, Mandarin, Cantonese, or Vietnamese. All patients will be compensated for completing study visits.
About half of the study patients in both arms will also be invited to participate in optional qualitative interviews, in which they will be asked questions about their expectations for the research study and their ideas for improving culturally sensitive mental health services. In addition, a small sample of Asian American patients who did not participate in the study but who have PCPs at the sites where the study was conducted will be contacted for a qualitative interview. This interview will address reasons why Asian American recruitment for the study was so challenging.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Capable of giving informed consent
- Adults 18 years of age or older
- Members of either Asian American or Latino American minority groups
- Currently experiencing depressive symptoms
Exclusion Criteria:
- Active unstable, untreated psychiatric illness precluding participation in study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Treatment as usual
The treatment as usual arm consists of two phone or in-person interviews:
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Experimental: Culturally focused psychiatric consultation
The consultation is comprised of 3 visits: 1a. Psychiatric diagnostic interview, self-rated questionnaires (in-person consultation). 1b. Intervention focused on learning about depression and how to treat it using culturally relevant resources. 2. Follow-up visit two weeks later to go over patients' questions, homework if applicable, and patients' ability to meet the goals outlined in the first visit (in-person or phone visit). 3. 6-month follow up: 6 months after the initial consultation, patients are asked about mental health symptoms and mental health treatment they might be receiving (phone visit unless patient requests in-person). |
The consultation is comprised of 3 visits: 1a. Psychiatric diagnostic interview, self-rated questionnaires (in-person consultation). 1b. Intervention focused on learning about depression and how to treat it using culturally relevant resources. 2. Follow-up visit two weeks later to go over patients' questions, homework if applicable, and patients' ability to meet the goals outlined in the first visit (in-person or phone visit). 3. 6-month follow up: 6 months after the initial consultation, patients are asked about mental health symptoms and mental health treatment they might be receiving (phone visit unless patient requests in-person). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine if a culturally focused psychiatric (CFP) consultation service can improve depressive symptoms and increase diagnosis and treatment of depression in Asian American and Latino American primary care patients at MGH.
Time Frame: 6 months after baseline assessment
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6 months after baseline assessment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the feasibility and cost associated with implementing a CFP consultation service within a primary care setting at MGH.
Time Frame: Two years after study enrollment began
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Two years after study enrollment began
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nhi-Ha Trinh, M.D., MPH, Massachusetts General Hospital
- Principal Investigator: Andres Bedoya, PhD, Massachusetts General Hospital
Publications and helpful links
General Publications
- Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
- Kirmayer LJ, Thombs BD, Jurcik T, Jarvis GE, Guzder J. Use of an expanded version of the DSM-IV outline for cultural formulation on a cultural consultation service. Psychiatr Serv. 2008 Jun;59(6):683-6. doi: 10.1176/ps.2008.59.6.683.
- Yeung A, Yu SC, Fung F, Vorono S, Fava M. Recognizing and engaging depressed Chinese Americans in treatment in a primary care setting. Int J Geriatr Psychiatry. 2006 Sep;21(9):819-23. doi: 10.1002/gps.1566.
- Trinh NH, Bedoya CA, Chang TE, Flaherty K, Fava M, Yeung A. A study of a culturally focused psychiatric consultation service for Asian American and Latino American primary care patients with depression. BMC Psychiatry. 2011 Oct 13;11:166. doi: 10.1186/1471-244X-11-166.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-P-000954
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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