Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)
Efficacy of CBT for Adherence and Depression in HIV Care Settings
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, United States, 02215
- Fenway Community Health Center
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- The Miriam Hospital
-
Providence, Rhode Island, United States, 02906
- Butler Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV-infected
- Current diagnosis of depression or prescribed an antidepressant medication with at least some residual symptoms (e.g., clinical global impressions [CGI] scale score of 2 or greater)
- Prescribed a stable regimen of highly active antiretroviral therapy (HAART) for HIV for at least 2 months
Exclusion Criteria:
- Active, untreated, and unstable major mental illness (i.e., untreated psychosis or mania) that would interfere with cognitive behavioral therapy (CBT) treatment for depression
- Diagnosis with any primary psychotic disorder, even if treated
- Treatment with CBT within the past year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Enhanced treatment as usual
Participants will receive the life-steps intervention and treatment as usual.
|
Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management
|
|
EXPERIMENTAL: CBT for adherence and depression (CBT-AD)
Participants will receive the life-steps and CBT-AD interventions.
|
Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management
12 therapy sessions delivered over 4 months, using cognitive behavioral strategies to target depressive symptoms and adherence to HIV medications
|
|
ACTIVE_COMPARATOR: ISP for adherence and depression (ISP-AD)
Participants will receive the life-steps and ISP-AD interventions.
|
Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management
12 therapy sessions delivered over 4 months, providing education and support that target depressive symptoms and adherence to HIV medications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
HIV medication adherence is assessed more frequently during the acute study period (baseline to post-treatment), and then at the follow up major visits.
|
Measured at each visit - baseline, interim visits, and after 4, 8, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in Severity of depression, as assessed on the Montgomery-Asberg Depression Rating Scale (MADRS) by a blinded independent assessor
Time Frame: Measured at baseline and after 4, 8, and 12 months
|
Measured at baseline and after 4, 8, and 12 months
|
|
|
changes in depression, as measured by the blinded assessor CGI rating
Time Frame: Measured at baseline and after 4, 8, and 12 months
|
Measured at baseline and after 4, 8, and 12 months
|
|
|
changes in RNA viral load
Time Frame: Measured at baseline and after 4, 8, and 12 months
|
Measured at baseline and after 4, 8, and 12 months
|
|
|
changes in CD4 cell count
Time Frame: Measured at baseline and after 4, 8, and 12 months
|
Measured at baseline and after 4, 8, and 12 months
|
|
|
changes in self-reported depression (CESD)
Time Frame: Measured at each visit
|
This is measured more frequently during the acute phase (pretreatment to post-treatment) then at the follow up assessments.
|
Measured at each visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven A. Safren, PhD, Partners HealthCare
- Study Director: C. Andres Bedoya, PhD, Partners HealthCare
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH084757 (NIH)
- 1R01MH084757-01A1 (NIH)
- DAHBR 9A-ASGA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.