Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)
Efficacy of CBT for Adherence and Depression in HIV Care Settings
3 other identifiers
interventional
240
1 country
4
Brief Summary
This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Sep 2008
Longer than P75 for not_applicable hiv
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 3, 2009
CompletedFirst Posted
Study publicly available on registry
August 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJune 18, 2013
June 1, 2013
4.6 years
August 3, 2009
June 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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)
Measured at each visit
Study Arms (3)
Enhanced treatment as usual
ACTIVE COMPARATORParticipants will receive the life-steps intervention and treatment as usual.
CBT for adherence and depression (CBT-AD)
EXPERIMENTALParticipants will receive the life-steps and CBT-AD interventions.
ISP for adherence and depression (ISP-AD)
ACTIVE COMPARATORParticipants will receive the life-steps and ISP-AD interventions.
Interventions
12 therapy sessions delivered over 4 months, using cognitive behavioral strategies to target depressive symptoms and adherence to HIV medications
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Fenway Community Health Center
Boston, Massachusetts, 02215, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven A. Safren, PhD
Partners HealthCare
- STUDY DIRECTOR
C. Andres Bedoya, PhD
Partners HealthCare
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Behavioral Medicine
Study Record Dates
First Submitted
August 3, 2009
First Posted
August 4, 2009
Study Start
September 1, 2008
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
June 18, 2013
Record last verified: 2013-06