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.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Glenn Wagner, RAND
ClinicalTrials.gov Identifier:
NCT00509340
First received: July 30, 2007
Last updated: June 20, 2013
Last verified: June 2013

July 30, 2007
June 20, 2013
June 2007
June 2013   (final data collection date for primary outcome measure)
Microelectronic medication adherence [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: No ]
Microelectronic medication adherence
Complete list of historical versions of study NCT00509340 on ClinicalTrials.gov Archive Site
Self-reported depression [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: Yes ]
self-reported depression
Not Provided
Not Provided
 
Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depression
  • HIV Infection
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.
  • 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
    Intervention: Behavioral: Cognitive behavioral therapy (CBT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00509340
R34 MH077503, R34MH077503, DAHBR 9A-ASNM
Yes
Glenn Wagner, RAND
RAND
National Institute of Mental Health (NIMH)
Principal Investigator: Glenn J. Wagner, PhD RAND
RAND
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP