Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy

June 20, 2013 updated by: Glenn Wagner, RAND

Cognitive Behavioral Adherence Intervention for Depressed HIV Patients

This study will compare the effectiveness of a cognitive behavioral intervention versus usual clinic care in helping HIV infected adults with depression to take their HIV medications on schedule.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Antiretroviral therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A high adherence rate to ART is required to adequately suppress the virus, limit drug resistance, and reduce transmission. HIV infected people who are depressed often experience increased difficulty with adhering to their ART regimen. This study will compare the effectiveness of a cognitive behavioral intervention that targets both depression and adherence versus usual care practices which may or may not include mental health intervention with the goal of improving ART adherence among HIV infected adults with depression who are experiencing difficulty with adhering to their medication regimen.

This study will last 24 weeks. Participants will be randomly assigned to receive the cognitive behavioral intervention or usual care. Study visits for all participants will occur at baseline and Weeks 4, 8, 16, and 24. Those receiving the intervention will also have visits at Weeks 1 and 2. Participants receiving the intervention will attend five individual treatment sessions followed by one to three booster treatment sessions; these sessions will coincide with the study visits.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States
        • LA Biomedical Institute at Harbor-UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • reports significant depressive symptoms as indicated by score of 10 or greater on PHQ-9
  • Currently taking ART for HIV infection
  • Less than 90% adherence rate to ART regimen
  • Capable of walking and in stable health
  • Speaks fluent English

Exclusion Criteria:

  • Depression therapy is needed immediately
  • Meets criteria for current drug dependency
  • Current diagnosis of psychotic disorder or bipolar depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Participants will receive usual clinical care, which may or may not include mental health treatment
Experimental: 2
Participants will receive cognitive behavioral intervention
Behavioral: Cognitive behavioral therapy (CBT)
Participants in this group will receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Microelectronic medication adherence
Time Frame: Measured at Weeks 16 and 24
Measured at Weeks 16 and 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-reported depression
Time Frame: Measured at Weeks 16 and 24
Measured at Weeks 16 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Glenn J. Wagner, PhD, RAND

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 30, 2007

First Submitted That Met QC Criteria

July 30, 2007

First Posted (Estimate)

July 31, 2007

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH077503 (U.S. NIH Grant/Contract)
  • DAHBR 9A-ASNM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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