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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00247195 |
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.
Condition | Intervention |
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Depression |
Behavioral: Culturally Congruent Assessment and Treatment |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Culturally Congruent Care for Hispanic Outpatients With Major Depressive Disorder (MDD) |
Estimated Enrollment: | 105 |
Study Start Date: | November 2005 |
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, participants will receive the third version of CCP-MDD along with antidepressant medication, weekly interpersonal psychotherapy, or a combination of the two. 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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
PHASE 1 FOCUS GROUP 1:
PHASE 1 FOCUS GROUP 2:
PHASES 1-3:
Pre-Engagement Phase
Treatment Phase
Exclusion Criteria
PHASE 1 FOCUS GROUP 1:
PHASE 1 FOCUS GROUP 2:
PHASES 1-3:
Pre-Engagement Phase
Treatment Phase
United States, New York | |
New York State Psychiatric Institute - Hispanic Treatment Program | |
New York, New York, United States, 10032 |
Principal Investigator: | Roberto Lewis-Fernandez, MD | New York State Psychiatric Institute |
Responsible Party: | NYS Center of Excellence for Cultural Competence, NY State Psychiatric Institute, Department of Psychiatry, Columbia University NYSPI ( Roberto Lewis-Fernandez, MD ) |
Study ID Numbers: | R34 MH73087, DSIR 82-SESC |
Study First Received: | October 28, 2005 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00247195 |
Health Authority: | United States: Federal Government |
Major Depression MDD Hispanic Primary Care Cultural Congruence |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |