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| Sponsor: | New York State Psychiatric Institute |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by (Responsible Party): | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00742573 |
Purpose
This study will determine whether combination treatment driven by patient choice is better than standardized medication treatment at retaining and improving Hispanic patients with major depressive disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Antidepressants through Texas Medication Algorithm (TMA) Behavioral: Brief Interpersonal Psychotherapy (IPT-B) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Improving the Effectiveness of Treatment for Depression in Hispanics |
| Estimated Enrollment: | 170 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1 Texas Medication Algorithm
Participants will receive medication treatment according to the Texas Medication Algorithm (TMA) for depression
|
Drug: Antidepressants through Texas Medication Algorithm (TMA)
Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Other Names:
|
|
Experimental: 2 Patient Choice
Participants will be offered brief interpersonal psychotherapy (IPT-B) alone or combined with the TMA for depression
|
Drug: Antidepressants through Texas Medication Algorithm (TMA)
Treatment with medication will follow the TMA for depression. Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.
Other Names:
Behavioral: Brief Interpersonal Psychotherapy (IPT-B)
IPT-B consists of twelve 50-minute sessions, divided into three phases, focusing on an interpersonal problem or problems.
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Retention of Hispanics in the treatment of major depressive disorder (MDD) continues to be a major public health problem. Hispanics drop out from treatment two to three times more frequently than non-Hispanic whites, despite the scarcity of treatment alternatives for Hispanics and their low rates of re-entry into the mental health care system. Consistent with the goals of Healthy People 2010 and the President's New Freedom Commission on Mental Health, the goal of this study is to test the efficacy in a research setting of a novel intervention to improve retention and response. This efficacy assessment would serve as a reference point for the development of future effectiveness trials in community settings.
Our intervention is founded on growing evidence that when depressed Hispanics seek help for mental health problems, they prefer to receive psychotherapy or combined treatment in the form of weekly in-person clinic visits. However, socioeconomic barriers, such as low-paying jobs with irregular hours, lack of child care, and limited time availability, often reduce treatment retention and result in dropout rates up to three times those of non-Hispanic whites. Based on emerging literature and on promising pilot data, we propose to study the efficacy for depressed Hispanics of an intervention that would allow for patient choice between the following options: 1) Medication alone, following the Texas Medication Algorithm for Depression (TMA); 2) Brief Interpersonal Psychotherapy (IPT-B) alone, with optional telephone sessions; or 3) Combined medication plus IPT-B. This intervention would allow switching of treatment modality (e.g., from IPT-B alone to combined treatment) at any point during the study period. We hypothesize that by permitting patient choice among evidence-based treatments, flexibility in the sequential use of treatments, and novel treatment delivery systems, this intervention will substantially increase retention of Hispanics in MDD treatment. Furthermore, we will examine mediators and moderators of retention, including stigma and insurance coverage.
We propose to test this intervention in depressed Hispanics seeking outpatient psychiatric treatment using a randomized trial with TMA as the control group. Both groups will have access to medication using the TMA but only one group will be offered IPT_B. . We will test the association between treatment, retention, and response over the course of acute MDD care (12 weeks), and will also obtain preliminary outcome data after 9 more months of treatment (i.e., for a total of 12 months). Our pilot data enable us to estimate the sample size for the acute phase, while the additional follow-up period allows us to examine the effect of choice over the longer-term course of MDD care.
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Carlos Blanco, MD, PhD | 212-543-6533 | cb255@columbia.edu |
| Contact: Donna Vermes, RN | 212-543-6534 | donna@nyspi.cpmc.columbia.edu |
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Mariela Castellanos 212-543-6620 castell@nyspi.cpmc.columbia.edu | |
| Contact: Mayumi Okuda 212-543-5132 okudama@nyspi.cpmc.columbia.edu | |
| Principal Investigator: Carlos Blanco, MD, PhD | |
| Principal Investigator: | Carlos Blanco, MD, PhD | New York State Psychiatric Institute |
More Information
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00742573 History of Changes |
| Other Study ID Numbers: | #5692, R01MH076051, DSIR 83-ATSO |
| Study First Received: | August 25, 2008 |
| Last Updated: | February 13, 2012 |
| Health Authority: | United States: Federal Government |
|
Major Depressive Disorder Mood Disorders Hispanic |
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |