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| Descriptive Information Fields | |||||||||
| Brief Title † | Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression | ||||||||
| Official Title † | Motivational Antidepressant Therapy for Hispanics | ||||||||
| Brief Summary | This study will evaluate the effectiveness of adding motivational interviewing to antidepressant treatment for major depressive disorder in Hispanic adults. |
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| 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 (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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Health Services Research, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Number of days in ADT (retention) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ] HAMD-17 (symptoms) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ] Sheehan Disability Scale (impairment) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ] Q-LES-Q (quality of life) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Client Satisfaction Questionnaire (patient satisfaction) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ] Composite Adherence Score (medication adherence) [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ] |
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| Condition † | Depression | ||||||||
| Intervention † | Drug: Standard antidepressant therapy (SADT) Behavioral: Motivational antidepressant therapy (MADT) |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 240 | ||||||||
| Start Date † | February 2008 | ||||||||
| Completion Date | July 2012 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 79 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00564278 | ||||||||
| Organization ID | R01 MH077226 | ||||||||
| Secondary IDs †† | DSIR 82-SESC | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | November 26, 2007 | ||||||||
| Last Updated Date | March 13, 2008 | ||||||||