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

This study has been terminated.
(Inability to recruit enough eligible participants at study site.)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Glenn Wagner, RAND Identifier:
First received: July 30, 2007
Last updated: June 20, 2013
Last verified: June 2013
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.

Condition Intervention Phase
HIV Infection
Behavioral: Cognitive behavioral therapy (CBT)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Adherence Intervention for Depressed HIV Patients

Resource links provided by NLM:

Further study details as provided by RAND:

Primary Outcome Measures:
  • Microelectronic medication adherence [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported depression [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: June 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00509340

United States, California
LA Biomedical Institute at Harbor-UCLA
Torrance, California, United States
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Principal Investigator: Glenn J. Wagner, PhD RAND
  More Information

Responsible Party: Glenn Wagner, Senior Behavioral Scientist, RAND Identifier: NCT00509340     History of Changes
Other Study ID Numbers: R34MH077503  DAHBR 9A-ASNM 
Study First Received: July 30, 2007
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by RAND:
poor antiretroviral adherence

Additional relevant MeSH terms:
Behavioral Symptoms processed this record on May 26, 2016