Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy
Recruitment status was Recruiting
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This study will compare the effectiveness of a cognitive behavioral intervention versus usual clinic care in helping HIV infected adults with depression to take their HIV medications on schedule.
Condition | Intervention | Phase |
---|---|---|
Depression HIV Infection |
Behavioral: Cognitive behavioral therapy (CBT) |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Cognitive Behavioral Adherence Intervention for Depressed HIV Patients |
- Microelectronic medication adherence [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: No ]
- Self-reported depression [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: Yes ]
Estimated Enrollment: | 70 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
No Intervention: 1
Participants will receive usual clinical care, which may or may not include mental health treatment
|
|
Experimental: 2
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.
|
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. 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.
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- reports significant depressive symptoms as indicated by score of 10 or greater on PHQ-9
- Currently taking ART for HIV infection
- Less than 90% adherence rate to ART regimen
- Capable of walking and in stable health
- Speaks fluent English
Exclusion Criteria:
- Depression therapy is needed immediately
- Meets criteria for current drug dependency
- Current diagnosis of psychotic disorder or bipolar depression
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Contact: Glenn J. Wagner, PhD | gwagner@rand.org |
United States, California | |
LA Biomedical Institute at Harbor-UCLA | Recruiting |
Torrance, California, United States | |
Principal Investigator: Mallory Witt, MD |
Principal Investigator: | Glenn J. Wagner, PhD | RAND |
![](https://webarchive.library.unt.edu/web/20130307130731im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Glenn Wagner, RAND |
ClinicalTrials.gov Identifier: | NCT00509340 History of Changes |
Other Study ID Numbers: | R34 MH077503, DAHBR 9A-ASNM |
Study First Received: | July 30, 2007 |
Last Updated: | March 9, 2009 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
antiretroviral adherence poor antiretroviral adherence |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Depression Depressive Disorder Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on March 05, 2013