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Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), March 2009
First Received: July 30, 2007   Last Updated: March 9, 2009   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00509340
  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 I

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Cognitive Behavioral Adherence Intervention for Depressed HIV Patients

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment: 70
Study Start Date: June 2007
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Participants will receive usual clinical care, which may or may not include mental health treatment
2: Experimental
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509340

Contacts
Contact: Glenn J. Wagner, PhD gwagner@rand.org

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

No publications provided

Responsible Party: RAND ( Glenn Wagner )
Study ID Numbers: R34 MH077503, DAHBR 9A-ASNM
Study First Received: July 30, 2007
Last Updated: March 9, 2009
ClinicalTrials.gov Identifier: NCT00509340     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
antiretroviral
adherence
poor antiretroviral adherence

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

ClinicalTrials.gov processed this record on November 05, 2009