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Antidepressant Medication and 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), September 2008
Sponsored by: 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 antidepressant therapy alone versus antidepressant therapy combined with cognitive behavioral therapy in helping HIV infected adults with depression to take their medications on schedule.


Condition Intervention Phase
Depression
HIV Infection
Drug: Antidepressant medication
Behavioral: Cognitive behavioral therapy (CBT)
Phase I

MedlinePlus related topics: AIDS Antidepressants Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Antidepressant and Behavioral Adherence Intervention for Depressed HIV Patients

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: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Participants will receive antidepressant medication
Drug: Antidepressant medication
The participant will be prescribed an antidepressant that is selected following a discussion and decision process between the participant and the study psychiatrist; selection of antidepressant will be individualized, not uniform across all participants.
2: Experimental
Participants will receive antidepressant medication and cognitive behavioral therapy
Drug: Antidepressant medication
The participant will be prescribed an antidepressant that is selected following a discussion and decision process between the participant and the study psychiatrist; selection of antidepressant will be individualized, not uniform across all participants.
Behavioral: Cognitive behavioral therapy (CBT)
In addition to prescribed antidepressant therapy, participants in this group will also 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. Antidepressant therapy has been shown to effectively treat depression. However, antidepressant therapy alone may not be sufficient for maintaining ART adherence. Another mental health treatment, such as cognitive behavioral therapy (CBT), may be needed to improve the likelihood of ART adherence. This study will compare the effectiveness of antidepressant therapy alone versus antidepressant therapy combined with CBT in 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 antidepressant therapy alone or antidepressant therapy plus CBT. Study visits for all participants will occur at baseline and Weeks 1, 2, 4, 8, 16, and 24. At these visits, depressive symptoms will be evaluated and medication adherence will be recorded. Antidepressant therapy will be tailored to each individual dependent on the participant's past medical history with antidepressant medication. Participants will take their antidepressant medication on a daily basis for the duration of the study. Participants receiving CBT 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:

  • Meets criteria for major depression, dysthymia, or subthreshold major depression
  • Antidepressant medication has been recommended by the clinic psychiatrist
  • Agrees to start antidepressant medication
  • Currently taking ART for HIV infection
  • Less than 90% adherence rate to ART regimen
  • Capable of walking and in stable health
  • Speaks fluent English or Spanish

Exclusion Criteria:

  • Antidepressant medication 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

Responsible Party: RAND ( Glenn Wagner )
Study ID Numbers: R34 MH77503, DAHBR 9A-ASNM
Study First Received: July 30, 2007
Last Updated: September 5, 2008
ClinicalTrials.gov Identifier: NCT00509340  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Depression
Mental Disorders
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Mood Disorders
Depressive Disorder
Retroviridae Infections
Immunologic Deficiency Syndromes
Behavioral Symptoms

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 30, 2009