Clincosm LogoSign in Get a demo

Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy

Sponsor
RAND (Other)
Overall Status
Terminated
CT.gov ID
NCT00509340
Collaborator
National Institute of Mental Health (NIMH) (NIH)
7
Enrollment
1
Location
2
Arms
72
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive behavioral therapy (CBT)
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cognitive Behavioral Adherence Intervention for Depressed HIV Patients
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Microelectronic medication adherence [Measured at Weeks 16 and 24]

Secondary Outcome Measures

  1. Self-reported depression [Measured at Weeks 16 and 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Glenn Wagner, Senior Behavioral Scientist, RAND
ClinicalTrials.gov Identifier:
NCT00509340
Other Study ID Numbers:
  • R34MH077503
  • R34MH077503
  • DAHBR 9A-ASNM
First Posted:
Jul 31, 2007
Last Update Posted:
Jun 21, 2013
Last Verified:
Jun 1, 2013
Keywords provided by Glenn Wagner, Senior Behavioral Scientist, RAND
antiretroviral
adherence
poor antiretroviral adherence
Additional relevant MeSH terms:
Depression
Depressive Disorder

Study Results

No Results Posted as of Jun 21, 2013