Clinical trial NCT00951028: Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)
Official title: Efficacy of CBT for Adherence and Depression in HIV Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Depression
HIV Infections
Keywords: Adherence
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-08-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: changes in HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores
timeFrame: Measured at each visit - baseline, interim visits, and after 4, 8, and 12 months
Secondary outcomes:
measure: changes in Severity of depression, as assessed on the Montgomery-Asberg Depression Rating Scale (MADRS) by a blinded independent assessor
timeFrame: Measured at baseline and after 4, 8, and 12 months
measure: changes in depression, as measured by the blinded assessor CGI rating
timeFrame: Measured at baseline and after 4, 8, and 12 months
measure: changes in RNA viral load
timeFrame: Measured at baseline and after 4, 8, and 12 months
measure: changes in CD4 cell count
timeFrame: Measured at baseline and after 4, 8, and 12 months
measure: changes in self-reported depression (CESD)
timeFrame: Measured at each visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Fenway Community Health Center
state: Massachusetts
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Partners HealthCare
name: Steven A. Safren, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Partners HealthCare
name: C. Andres Bedoya, PhD
role: STUDY_DIRECTOR
References: