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| Descriptive Information Fields | |||||||||
| Brief Title † | Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression | ||||||||
| Official Title † | Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach | ||||||||
| Brief Summary | This study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among Hispanics. |
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| Detailed Description | Depression is a serious mental illness characterized by symptoms that can interfere with a person's ability to work, study, eat, sleep, and enjoy activities that were once pleasurable. Studies have shown that people of Hispanic descent tend to underutilize mental health care services. Additionally, Hispanics have demonstrated lower compliance and completion rates for antidepressant treatment. This may be due to low socioeconomic status, lack of family financial support, and inadequate communication with mental health care providers. Motivational interviewing is a goal-oriented type of therapy that focuses on eliciting behavior change by identifying and mobilizing a person's values. This study will determine the effectiveness of culturally sensitive motivational interviewing in improving antidepressant medication adherence in Hispanics. Participants in this 6-month, open-label study will be randomly assigned to receive either motivational interviewing in addition to their antidepressant therapy or treatment as usual. All participants will first attend a 45-minute screening visit, which will include questionnaires and an interview about psychiatric symptoms, medication attitudes, and medication adherence behavior. Participants will also receive an electronic medication container that will record how consistently medication is taken. Participants assigned to motivational interviewing will then attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. The group assigned to treatment as usual will not partake in motivational interviewing, but will continue to receive their normal care. All participants will return to the study site for follow-up assessments, which will include measures of antidepressant adherence, at Months 2 and 5. |
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| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Medication adherence, as measured by electronic pill container [ Time Frame: Measured immediately post-treatment and at Months 2 and 5 follow-ups ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Treatment retention [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] Depression [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] Medication attitudes [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] |
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| Condition † | Depression | ||||||||
| Intervention † | Behavioral: Motivational interviewing Behavioral: Treatment as usual |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 90 | ||||||||
| Start Date † | April 2006 | ||||||||
| Completion Date | August 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00356304 | ||||||||
| Organization ID | K23 MH74860 | ||||||||
| Secondary IDs †† | DSIR 8K-RT | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | July 21, 2006 | ||||||||
| Last Updated Date | February 13, 2008 | ||||||||
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