Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247195
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2005-10-28
Brief Title:
Effectiveness of Culturally Based Congruent Care in Treating Hispanics With Major Depressive Disorder
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Culturally Congruent Care for Hispanic Outpatients With Major Depressive Disorder MDD
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will develop and evaluate the effectiveness of a culturally based program that aims to facilitate entry retention and successful treatment in specialized mental health services for Hispanics with major depressive disorder
Detailed Description:
Major depressive disorder MDD is a type of depression that is characterized by a combination of symptoms that can interfere with the ability to work study sleep eat and enjoy activities that were once pleasurable Studies have shown that individuals of Hispanic descent underutilize specialized mental health care services SMHS despite their need for it In addition Hispanic individuals have been associated with lower rates of retention in specialized mental health treatment In particular dropout rates from medication therapy for the treatment of MDD within SMHS are two to three times higher in Hispanics than in non-Hispanic whites This study will develop and evaluate the effectiveness of a culturally-based program that aims to facilitate entry retention and successful treatment in specialized mental health services for Hispanics with MDD
This open-label study will consist of four phases Participants will be recommended for inclusion in the study upon receiving a diagnosis of MDD based on a standard health questionnaire completed in their primary care physicians office Phase 1 of the study will entail an initial evaluation of the culturally congruent program of care for Hispanics with MDD CCP-MDD Participants will be placed in one of two focus groups each composed of 8 to 10 people One group will include individuals referred by their primary care physician The other group will include family members of Hispanics with MDD Discussions will focus on participants understandings of depression-like illness their treatment expectations for these conditions and their perceived barriers to SMHS utilization Information gathered in the focus groups will be used to develop a second version of CCP-MDD Phase 2 of the study will evaluate the revised version of CCP-MDD and will include additional treatments with antidepressant medication weekly interpersonal psychotherapy or a combination of the two Following treatment participants will take part in a focus group which will involve participant feedback
Based on the information obtained in the focus groups and from clinical observations a third version of CCP-MDD will be developed In Phase 3 two sets of primary care offices will participate One set will be assigned to the intervention arm and receive the third version of the CCP-MDD intervention A second set will be assigned to the control arm and receive usual referral to mental health services at the research site All participants will be offered the same choice of treatments antidepressant medication weekly interpersonal psychotherapy or a combination of the two Treatment in both arms will be of the same duration 18 wks Focus groups will be held following treatment in order to obtain information about individuals satisfaction or dissatisfaction with their care Based on these findings as well as clinical observations a fourth and final version of CCP-MDD will be developed in Phase 4 All treatments will last a total of 18 weeks A follow-up session will be held at Week 30 to assess depressive symptoms
This open-label study will consist of four phases Participants will be recommended for inclusion in the study upon receiving a diagnosis of MDD based on a standard health questionnaire completed in their primary care physicians office Phase 1 of the study will entail an initial evaluation of the culturally congruent program of care for Hispanics with MDD CCP-MDD Participants will be placed in one of two focus groups each composed of 8 to 10 people One group will include individuals referred by their primary care physician The other group will include family members of Hispanics with MDD Discussions will focus on participants understandings of depression-like illness their treatment expectations for these conditions and their perceived barriers to SMHS utilization Information gathered in the focus groups will be used to develop a second version of CCP-MDD Phase 2 of the study will evaluate the revised version of CCP-MDD and will include additional treatments with antidepressant medication weekly interpersonal psychotherapy or a combination of the two Following treatment participants will take part in a focus group which will involve participant feedback
Based on the information obtained in the focus groups and from clinical observations a third version of CCP-MDD will be developed In Phase 3 two sets of primary care offices will participate One set will be assigned to the intervention arm and receive the third version of the CCP-MDD intervention A second set will be assigned to the control arm and receive usual referral to mental health services at the research site All participants will be offered the same choice of treatments antidepressant medication weekly interpersonal psychotherapy or a combination of the two Treatment in both arms will be of the same duration 18 wks Focus groups will be held following treatment in order to obtain information about individuals satisfaction or dissatisfaction with their care Based on these findings as well as clinical observations a fourth and final version of CCP-MDD will be developed in Phase 4 All treatments will last a total of 18 weeks A follow-up session will be held at Week 30 to assess depressive symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 82-SESC | US NIH GrantContract | None | httpsreporternihgovquickSearchR34MH073087 |
| R34MH073087 | NIH | None | None |