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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: | NCT00951028 |
This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.
Condition | Intervention |
---|---|
HIV Depression |
Behavioral: Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD) Behavioral: Life-steps adherence treatment Behavioral: Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of CBT for Adherence and Depression in HIV Care Settings |
Estimated Enrollment: | 200 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | August 2013 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Enhanced treatment as usual: Active Comparator
Participants will receive the life-steps intervention and treatment as usual.
|
Behavioral: Life-steps adherence treatment
Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management
|
CBT for adherence and depression (CBT-AD): Experimental
Participants will receive the life-steps and CBT-AD interventions.
|
Behavioral: Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD)
12 therapy sessions delivered over 4 months, using cognitive behavioral strategies to target depressive symptoms and adherence to HIV medications
Behavioral: Life-steps adherence treatment
Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management
|
ISP for adherence and depression (ISP-AD): Active Comparator
Participants will receive the life-steps and ISP-AD interventions.
|
Behavioral: Life-steps adherence treatment
Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management
Behavioral: Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)
12 therapy sessions delivered over 4 months, providing education and support that target depressive symptoms and adherence to HIV medications.
|
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.
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jackie Bullis, BS | 617-643-2147 | jbullis@partners.org |
Contact: Jared Israel, BS | 617-643-0387 | jiisrael@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Sub-Investigator: Gregory Robbins, MD, MPH | |
Sub-Investigator: Rochelle Walensky, MD, MPH | |
Fenway Community Health Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Sub-Investigator: Kenneth Mayer, MD | |
United States, Rhode Island | |
The Miriam Hospital | Recruiting |
Providence, Rhode Island, United States, 02906 | |
Sub-Investigator: Erna Kojic, MD | |
Butler Hospital | Active, not recruiting |
Providence, Rhode Island, United States, 02906 |
Principal Investigator: | Steven A. Safren, PhD | Partners Healthcare |
Study Director: | C. Andres Bedoya, PhD | Partners Healthcare |
Responsible Party: | Partners Healthcare ( Steven Safren, PhD ) |
Study ID Numbers: | R01 MH084757, 1-R01-MH084757-01A1, DAHBR 9A-ASGA |
Study First Received: | August 3, 2009 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00951028 History of Changes |
Health Authority: | United States: Federal Government |
Adherence |
Depression Mental Disorders HIV Infections Acquired Immunodeficiency Syndrome |
Mood Disorders Depressive Disorder Behavioral Symptoms |
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |