Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression
Recruitment status was Recruiting
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| First Received Date ICMJE | July 21, 2006 | ||||||||
| Last Updated Date | March 12, 2009 | ||||||||
| Start Date ICMJE | April 2006 | ||||||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Medication adherence, as measured by electronic pill container (measured immediately post-treatment and at Months 2 and 5 follow-ups) | ||||||||
| Change History | Complete list of historical versions of study NCT00356304 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression | ||||||||
| Official Title ICMJE | 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 Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Interian A, Martinez IE, Guarnaccia PJ, Vega WA, Escobar JI. A qualitative analysis of the perception of stigma among Latinos receiving antidepressants. Psychiatr Serv. 2007 Dec;58(12):1591-4. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | August 2010 | ||||||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00356304 | ||||||||
| Other Study ID Numbers ICMJE | K23 MH074860, DSIR 8K-RT | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Alejandro Interian, PhD, UMDNJ--Robert Wood Johnson Medical School | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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