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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00509340 |
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.
Condition | Intervention | Phase |
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Depression HIV Infection |
Drug: Antidepressant medication Behavioral: Cognitive behavioral therapy (CBT) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Antidepressant and Behavioral Adherence Intervention for Depressed HIV Patients |
Estimated Enrollment: | 70 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive antidepressant medication
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Drug: Antidepressant medication
The participant will be prescribed an antidepressant that is selected following a discussion and decision process between the participant and the study psychiatrist; selection of antidepressant will be individualized, not uniform across all participants.
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2: Experimental
Participants will receive antidepressant medication and cognitive behavioral therapy
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Drug: Antidepressant medication
The participant will be prescribed an antidepressant that is selected following a discussion and decision process between the participant and the study psychiatrist; selection of antidepressant will be individualized, not uniform across all participants.
Behavioral: Cognitive behavioral therapy (CBT)
In addition to prescribed antidepressant therapy, participants in this group will also receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression.
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | RAND ( Glenn Wagner ) |
Study ID Numbers: | R34 MH77503, DAHBR 9A-ASNM |
Study First Received: | July 30, 2007 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00509340 |
Health Authority: | United States: Federal Government |
antiretroviral adherence poor antiretroviral adherence |
Virus Diseases Sexually Transmitted Diseases, Viral Depression Mental Disorders HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Mood Disorders Depressive Disorder Retroviridae Infections Immunologic Deficiency Syndromes Behavioral Symptoms |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |