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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven A. Safren, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00951028
First received: August 3, 2009
Last updated: June 17, 2013
Last verified: June 2013
  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
HIV Infections
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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of CBT for Adherence and Depression in HIV Care Settings

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    HIV medication adherence is assessed more frequently during the acute study period (baseline to post-treatment), and then at the follow up major visits.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • changes in depression, as measured by the blinded assessor CGI rating [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ]
  • changes in RNA viral load [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ]
  • changes in CD4 cell count [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ]
  • changes in self-reported depression (CESD) [ Time Frame: Measured at each visit ] [ Designated as safety issue: No ]
    This is measured more frequently during the acute phase (pretreatment to post-treatment) then at the follow up assessments.


Enrollment: 240
Study Start Date: September 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enhanced treatment as usual
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
Experimental: CBT for adherence and depression (CBT-AD)
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
Active Comparator: ISP for adherence and depression (ISP-AD)
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951028

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Fenway Community Health Center
Boston, Massachusetts, United States, 02215
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Steven A. Safren, PhD Partners HealthCare
Study Director: C. Andres Bedoya, PhD Partners HealthCare
  More Information

No publications provided

Responsible Party: Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00951028     History of Changes
Other Study ID Numbers: R01 MH084757, R01MH084757, 1-R01-MH084757-01A1, DAHBR 9A-ASGA
Study First Received: August 3, 2009
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Adherence

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Depression
Depressive Disorder
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014