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Clinical Trials/NCT00247195
NCT00247195
Completed
N/A

Culturally Congruent Care for Hispanic Outpatients With Major Depressive Disorder (MDD)

New York State Psychiatric Institute1 site in 1 country113 target enrollmentNovember 2005
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
New York State Psychiatric Institute
Enrollment
113
Locations
1
Primary Endpoint
Entry into specialty mental health care from primary care
Status
Completed
Last Updated
13 years ago

Overview

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 physician's 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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
August 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • PHASE 1 FOCUS GROUP 1:
  • Self-identifies as Hispanic
  • Screened positive for MDD during the previous study (WH-PCDP), but was unable to participate in that study due to ongoing depression treatment at the time
  • Spanish-speaking
  • PHASE 1 FOCUS GROUP 2:
  • Self-identifies as Hispanic
  • Family member of a patient with MDD who participated in the previous study (WH-PCDP)
  • Spanish-speaking
  • PHASES 1-3:
  • Pre-Engagement Phase

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Entry into specialty mental health care from primary care

Time Frame: Measured at study completion

Entry into treatment for major depressive disorder after evaluation

Time Frame: Measured at study completion

Dropout from stepped care

Time Frame: Measured throughout the study

Secondary Outcomes

  • Score on the Quality of Life Index(Measured at Week 30)
  • Score on the Social Adjustment Scale - Self-report version(Measured at Week 30)
  • Score on the Nervios Treatment Scale(Measured at Week 30)
  • Score on the Clinical Global Impression Scale - Patient version(Measured at Week 30)
  • Score on the Hamilton Depression Scale (17-item)(Measured at Week 30)
  • Score on the Clinical Global Impression Scale(Measured at Week 30)
  • Score on the Working Alliance Inventory(Measured at Week 30)
  • Score on the Client Satisfaction Questionnaire(Measured at Week 30)
  • Score on the Side Effects Checklist(Measured at Week 18)

Study Sites (1)

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