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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: | NCT00564278 |
This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.
Condition | Intervention |
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Depression |
Drug: Standard antidepressant therapy (SADT) Behavioral: Motivational antidepressant therapy (MADT) |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Motivational Antidepressant Therapy for Hispanics |
Estimated Enrollment: | 240 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive standard antidepressant therapy
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Drug: Standard antidepressant therapy (SADT)
Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
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2: Experimental
Participants will receive motivational antidepressant therapy
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Behavioral: Motivational antidepressant therapy (MADT)
The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.
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Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. There are multiple types of depressive disorders, with major depressive disorder (MDD) being one of the most common. The following symptoms may be signs of MDD: persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. Despite the widespread use of drug treatment for MDD in the United States, it continues to be underutilized in the Hispanic population. The retention rate in antidepressant therapy (ADT) among the Hispanic population is half that of the Caucasian population. It is believed that cultural factors and ambivalence toward seeking treatment interfere with ADT retention in Hispanic adults. Motivational antidepressant therapy (MADT) involves the use of motivational interviewing (MI) to discuss treatment with patients. This study will compare the effectiveness of culturally-specific MADT versus standard antidepressant therapy (SADT) in treating Hispanic adults with MDD.
Participants in this single-blind study will be randomly assigned to receive either MADT or SADT. A psychiatrist will conduct all medication visits and will recommend an initial antidepressant for each participant. Depending on treatment assignment, psychiatrists will use either the MADT or SADT approach in the medication visits. During the visits, participants will complete questionnaires, undergo vital sign measurements, and receive medication. Medication visits will occur weekly during the first two weeks, every 2 weeks for the next 6 weeks, and then on a monthly basis until the end of the study. In addition to visits with the psychiatrist, participants will complete 15-minute individual interviews with a clinician from the Hispanic Treatment Program. Individual interviews will take place every 2 weeks in the first month of treatment, monthly until the third month, and then every other month thereafter. The association between treatment, retention, and response will be assessed after 3 months of treatment. Preliminary outcome data will be obtained after 6 more months of continued treatment. After the end of treatment, participants may randomly be asked to participate in a small "focus group" to discuss personal experiences with study treatments.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Roberto Lewis-Fernandez, MD | 212-543-6512 | rlewis@nyspi.cpmc.columbia.edu |
Contact: Donna Vermes, RN | 212-543-6534 | donna@nyspi.cpmc.columbia.edu |
United States, New York | |
New York State Psychiatric Institute, 1051 Riverside Drive #69 | Recruiting |
New York, New York, United States, 10032 | |
Contact 212-543-5367 | |
Contact: Melissa Rosario 212-543-6514 rosario@nyspi.cpmc.columbia.edu | |
Principal Investigator: Roberto Lewis-Fernandez, MD | |
Sub-Investigator: Carlos Blanco, MD, PhD |
Principal Investigator: | Roberto Lewis-Fernandez, MD | New York State Psychiatric Institute |
Responsible Party: | New York State Psychiatric Institute ( Roberto Lewis-Fernandez, MD ) |
Study ID Numbers: | R01 MH077226, DSIR 82-SESC |
Study First Received: | November 26, 2007 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00564278 |
Health Authority: | United States: Federal Government |
Hispanic Americans Major Depressive Disorder Antidepressant Therapy |
Motivational Interviewing Treatment Retention Treatment Adherence |
Depression Depressive Disorder, Major Urinary Retention Depressive Disorder Mirtazapine Citalopram Paroxetine Duloxetine |
Behavioral Symptoms Mental Disorders Nortriptyline Venlafaxine Bupropion Mood Disorders Sertraline Dexetimide |