Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 3, 2009 | ||||||||
| Last Updated Date | May 22, 2012 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
changes in HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores [ Time Frame: Measured at each visit - baseline, interim visits, and after 4, 8, and 12 months ] [ Designated as safety issue: No ] HIV medication adherence is assessed more frequently during the acute study period (baseline to post-treatment), and then at the follow up major visits. |
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| Original Primary Outcome Measures ICMJE |
HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00951028 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 | Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study) | ||||||||
| Official Title ICMJE | Efficacy of CBT for Adherence and Depression in HIV Care Settings | ||||||||
| Brief Summary | This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression. |
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| Detailed Description | People infected with HIV are more likely to suffer from depression than those not infected, with studies finding anywhere from 20% to 50% of HIV-infected individuals having significant depressive symptoms. Depression, in addition to causing persistent sadness and inability to feel pleasure, is related to a lack of HIV treatment adherence. Treatment adherence (making sure to take every pill as prescribed by doctors) is critically important to successful treatment of HIV, because missing even a few doses gives the HIV virus an opportunity to develop immunity to the medication. Poor adherence is related to worse medical outcomes, but even a small, 10% improvement rate in adherence may improve these outcomes. This study will test the efficacy of cognitive behavioral therapy (CBT) that addresses both depression and treatment adherence for HIV-infected people. Participation in this study will last 1 year, including follow-up visits. All participants will complete an initial one-visit intervention addressing treatment adherence. Then after 2 weeks, participants will be randomly assigned to one of three conditions: CBT for HIV medication adherence and depression (CBT-AD), information and supportive psychotherapy for HIV medication adherence and depression (ISP-AD), or enhanced treatment as usual (ETAU). Participants receiving CBT-AD and ISP-AD will complete 12 therapy sessions over 4 months and will be asked to report any changes to their psychological or HIV treatments. CBT-AD will involve learning to identify and change problematic patterns of thought and behavior, while ISP-AD will involve education and supportive psychotherapy. Participants receiving ETAU will receive only the initial session on HIV medication adherence and will be asked about their psychological and HIV treatment every other week for 4 months. Major study assessments will take place at baseline and after 4, 8, and 12 months. Assessments will include completing diagnostic interviews and questionnaires, measuring medication adherence through an electronic pill cap, and determining CD4 cell count and viral load (indicators of HIV treatment effectiveness). |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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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 | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | August 2013 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00951028 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH084757, R01MH084757, 1-R01-MH084757-01A1, DAHBR 9A-ASGA | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Steven A. Safren, Massachusetts General Hospital | ||||||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||||||
| Verification Date | May 2012 | ||||||||
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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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