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Culturally-focused Consultation for Asian Americans and Latino Americans (CFP)

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ClinicalTrials.gov Identifier: NCT01239407
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : October 30, 2014
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Nhi-Ha T. Trinh, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE November 10, 2010
First Posted Date  ICMJE November 11, 2010
Last Update Posted Date October 30, 2014
Study Start Date  ICMJE December 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Culturally-focused Consultation for Asian Americans and Latino Americans
Official Title  ICMJE Culturally Focused Psychiatric Consultation Service for Asian American and Latino American Primary Care Patients With Depression
Brief Summary The purpose of this study is 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 the Massachusetts General Hospital.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE Behavioral: 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).

Study Arms  ICMJE
  • No Intervention: Treatment as usual

    The treatment as usual arm consists of two phone or in-person interviews:

    1. Patients are asked questions about their mental health, their views of mental health, and how they cope with their mental health (including any treatment they might be receiving).
    2. Patients are asked the same questions 6 months after the initial interview.
  • 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).

    Intervention: Behavioral: Culturally focused psychiatric consultation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2012)
122
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2010)
120
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01239407
Other Study ID Numbers  ICMJE 2009-P-000954
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nhi-Ha T. Trinh, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Robert Wood Johnson Foundation
Investigators  ICMJE
Principal Investigator: Nhi-Ha Trinh, M.D., MPH Massachusetts General Hospital
Principal Investigator: Andres Bedoya, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP