Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy
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|ClinicalTrials.gov Identifier: NCT00509340|
Recruitment Status : Terminated (Inability to recruit enough eligible participants at study site.)
First Posted : July 31, 2007
Last Update Posted : June 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression HIV Infection||Behavioral: Cognitive behavioral therapy (CBT)||Phase 1|
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. This study will compare the effectiveness of a cognitive behavioral intervention that targets both depression and adherence versus usual care practices which may or may not include mental health intervention with the goal of 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 the cognitive behavioral intervention or usual care. Study visits for all participants will occur at baseline and Weeks 4, 8, 16, and 24. Those receiving the intervention will also have visits at Weeks 1 and 2. Participants receiving the intervention will attend five individual treatment sessions followed by one to three booster treatment sessions; these sessions will coincide with the study visits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Behavioral Adherence Intervention for Depressed HIV Patients|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
No Intervention: 1
Participants will receive usual clinical care, which may or may not include mental health treatment
Participants will receive cognitive behavioral intervention
Behavioral: Cognitive behavioral therapy (CBT)
Participants in this group will receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression.
- Microelectronic medication adherence [ Time Frame: Measured at Weeks 16 and 24 ]
- Self-reported depression [ Time Frame: Measured at Weeks 16 and 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509340
|United States, California|
|LA Biomedical Institute at Harbor-UCLA|
|Torrance, California, United States|
|Principal Investigator:||Glenn J. Wagner, PhD||RAND|