DepressionCFPNCT01239407
Culturally-focused Consultation for Asian Americans and Latino Americans
A study testing Culturally focused psychiatric consultation in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Culturally focused psychiatric consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Aug 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active unstable, untreated psychiatric illness precluding participation in study
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Culturally Focused Psychiatric Consultation Service for Asian American and Latino American Primary Care Patients With Depression
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Culturally focused psychiatric consultation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally focused psychiatric consultationBehavioural
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.
- 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).
- 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 group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | 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. |
| Culturally focused psychiatric consultation | Experimental | 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). Receives: Behavioral: Culturally focused psychiatric consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after baseline assessment
Secondary outcomes (1)
To determine the feasibility and cost associated with implementing a CFP consultation service within a primary care setting at MGH.
Measured: Two years after study enrollment began
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startDec 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Nhi-Ha T. Trinh, Massachusetts General Hospital
- Investigators
- Nhi-Ha Trinh, M.D., MPH, Principal investigator, Massachusetts General HospitalAndres Bedoya, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239407
- Sponsor's protocol ID
- 2009-P-000954
- Acronym
- CFP
- Status last verified
- Apr 2012
- First submitted
- 10 Nov 2010
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18511590Yeung 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.
PubMed 16955440Kroenke 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.
PubMed 14583691Trinh 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.
PubMed 21995514
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Focused Psychiatric Consultation Service for Asian American and Latino American Primary Care Patients With Depression
- ClinicalTrials.gov ID
- NCT01239407
- Acronym / sponsor ID
- CFP / 2009-P-000954
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Dec 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –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. |
| Culturally focused psychiatric consultation | Experimental | Behavioral: Culturally focused psychiatric consultationThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Active unstable, untreated psychiatric illness precluding participation in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally focused psychiatric consultationThe 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). | Behavioural | Culturally focused psychiatric consultation |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
- Background: PubMed 18511590Kirmayer 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.
- Background: PubMed 16955440Yeung 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.
- Background: PubMed 14583691Kroenke 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.
- Derived from this study: PubMed 21995514Trinh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nhi-Ha Trinh, M.D., MPH principal investigator
Massachusetts General Hospital
Andres Bedoya, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally focused psychiatric consultation in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
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 4 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 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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). 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 NCT01239407, which also lists 4 linked publications.
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 30 Oct 2014.