Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)

Study Overview
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Brief Summary
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This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.

Detailed Description
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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).

Official Title
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Efficacy of CBT for Adherence and Depression in HIV Care Settings

Conditions
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HIV, Depression, HIV Infections

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced treatment as usual<br>Participants will receive the life-steps intervention and treatment as usual. | Behavioral: Life-steps adherence treatment<br>* Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management<br>|
| Experimental: CBT for adherence and depression (CBT-AD)<br>Participants will receive the life-steps and CBT-AD interventions. | Behavioral: Cognitive behavioral therapy (CBT) for adherence and depression (CBT-AD)<br>* 12 therapy sessions delivered over 4 months, using cognitive behavioral strategies to target depressive symptoms and adherence to HIV medications<br>Behavioral: Life-steps adherence treatment<br>* Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management<br>|
| Active Comparator: ISP for adherence and depression (ISP-AD)<br>Participants will receive the life-steps and ISP-AD interventions. | Behavioral: Life-steps adherence treatment<br>* Single-session adherence treatment that targets informational, problem solving, and cognitive-behavioral steps geared toward improving HIV medication adherence and self-management<br>Behavioral: Information and supportive psychotherapy (ISP) for adherence and depression (ISP-AD)<br>* 12 therapy sessions delivered over 4 months, providing education and support that target depressive symptoms and adherence to HIV medications.<br>|

What is the study measuring?
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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 | 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 |  | Measured at baseline and after 4, 8, and 12 months | 
| changes in depression, as measured by the blinded assessor CGI rating |  | Measured at baseline and after 4, 8, and 12 months | 
| changes in RNA viral load |  | Measured at baseline and after 4, 8, and 12 months | 
| changes in CD4 cell count |  | Measured at baseline and after 4, 8, and 12 months | 
| changes in self-reported depression (CESD) | This is measured more frequently during the acute phase (pretreatment to post-treatment) then at the follow up assessments. | Measured at each visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence