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Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), July 2009
First Received: August 3, 2009   No Changes Posted
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00951028
  Purpose

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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Self-reported depression, as measured by the Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ]
  • HIV progression, as measured by RNA viral load and CD4 cell counts [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ]

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.

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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951028

Contacts
Contact: Jackie Bullis, BS 617-643-2147 jbullis@partners.org
Contact: Jared Israel, BS 617-643-0387 jiisrael@partners.org

Locations
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
Sponsors and Collaborators
Investigators
Principal Investigator: Steven A. Safren, PhD Partners Healthcare
Study Director: C. Andres Bedoya, PhD Partners Healthcare
  More Information

No publications provided

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

Keywords provided by National Institute of Mental Health (NIMH):
Adherence

Study placed in the following topic categories:
Depression
Mental Disorders
HIV Infections
Acquired Immunodeficiency Syndrome
Mood Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 24, 2009