Clinical trial NCT00564278
Conditions: Depression
Keywords: Hispanic Americans Major Depressive Disorder Antidepressant Therapy Motivational Interviewing Treatment Retention Treatment Adherence
Sponsor: New York State Psychiatric Institute
Start date: 2008-02-01; Completion date: 2013-08-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults.

Detailed description:
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 being one of the most common. The following symptoms may be signs of major depression: 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 major depression 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 major depression.

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.

Arms: arm 1: Participants will receive standard antidepressant therapy, including selecting among 9 FDA-approved antidepressants from several classes. arm 2: Participants will receive motivational antidepressant therapy, including selecting among the same list of 9 FDA-approved antidepressants from several classes as in the control arm.
Interventions: intervention 1: Standard antidepressant therapy (SADT) intervention 2: Motivational antidepressant therapy (MADT)
Intervention descriptions: intervention 1: 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). intervention 2: The same medication treatment for depression will be offered and supplemented with techniques from motivational interviewing.

Protocol documents: