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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:
ClinicalTrials.gov Identifier:
NCT00509340
First Posted: July 31, 2007
Last Update Posted: June 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Glenn Wagner, RAND
  Purpose
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
Depression HIV Infection Behavioral: Cognitive behavioral therapy (CBT) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Glenn Wagner, RAND:

Primary Outcome Measures:
  • Microelectronic medication adherence [ Time Frame: Measured at Weeks 16 and 24 ]

Secondary Outcome Measures:
  • Self-reported depression [ Time Frame: Measured at Weeks 16 and 24 ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509340


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

Responsible Party: Glenn Wagner, Senior Behavioral Scientist, RAND
ClinicalTrials.gov Identifier: NCT00509340     History of Changes
Other Study ID Numbers: R34MH077503 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASNM
First Submitted: July 30, 2007
First Posted: July 31, 2007
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by Glenn Wagner, RAND:
antiretroviral
adherence
poor antiretroviral adherence

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