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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:
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
  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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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: NCT00509340

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

No publications provided

Responsible Party: Glenn Wagner, Senior Behavioral Scientist, RAND
ClinicalTrials.gov Identifier: NCT00509340     History of Changes
Other Study ID Numbers: R34 MH077503, 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:
antiretroviral
adherence
poor antiretroviral adherence

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

ClinicalTrials.gov processed this record on November 24, 2014