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| Descriptive Information Fields | |||||
| Brief Title † | Antidepressant Medication and Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy | ||||
| Official Title † | Antidepressant and Behavioral Adherence Intervention for Depressed HIV Patients | ||||
| Brief Summary | This study will compare the effectiveness of antidepressant therapy alone versus antidepressant therapy combined with cognitive behavioral therapy in helping HIV infected adults with depression to take their medications on schedule. |
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| Detailed Description | Antiretroviral therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A high adherence rate to ART is required to adequately suppress the virus, limit drug resistance, and reduce transmission. HIV infected people who are depressed often experience increased difficulty with adhering to their ART regimen. Antidepressant therapy has been shown to effectively treat depression. However, antidepressant therapy alone may not be sufficient for maintaining ART adherence. Another mental health treatment, such as cognitive behavioral therapy (CBT), may be needed to improve the likelihood of ART adherence. This study will compare the effectiveness of antidepressant therapy alone versus antidepressant therapy combined with CBT in improving ART adherence among HIV infected adults with depression who are experiencing difficulty with adhering to their medication regimen. This study will last 24 weeks. Participants will be randomly assigned to receive antidepressant therapy alone or antidepressant therapy plus CBT. Study visits for all participants will occur at baseline and Weeks 1, 2, 4, 8, 16, and 24. At these visits, depressive symptoms will be evaluated and medication adherence will be recorded. Antidepressant therapy will be tailored to each individual dependent on the participant's past medical history with antidepressant medication. Participants will take their antidepressant medication on a daily basis for the duration of the study. Participants receiving CBT will attend five individual treatment sessions followed by one to three booster treatment sessions; these sessions will coincide with the study visits. |
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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 † | Microelectronic medication adherence [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Self-reported depression [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: Yes ] | ||||
| Condition † | Depression HIV Infection |
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| Intervention † | Drug: Antidepressant medication Behavioral: Cognitive behavioral therapy (CBT) |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 70 | ||||
| Start Date † | June 2007 | ||||
| Completion Date | June 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00509340 | ||||
| Organization ID | R34 MH77503 | ||||
| Secondary IDs †† | DAHBR 9A-ASNM | ||||
| 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 30, 2007 | ||||
| Last Updated Date | February 29, 2008 | ||||
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