Back to resultsCognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy
Primary Purpose
Depression, HIV Infection
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring antiretroviral, adherence, poor antiretroviral adherence
Eligibility 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
Sites / Locations
- LA Biomedical Institute at Harbor-UCLA
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
Participants will receive usual clinical care, which may or may not include mental health treatment
Participants will receive cognitive behavioral intervention
Outcomes
Primary Outcome Measures
Microelectronic medication adherence
Secondary Outcome Measures
Self-reported depression
Full Information
NCT ID
NCT00509340
First Posted
July 30, 2007
Last Updated
June 20, 2013
Sponsor
RAND
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00509340
Brief Title
Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy
Official Title
Cognitive Behavioral Adherence Intervention for Depressed HIV Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit enough eligible participants at study site.
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RAND
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, HIV Infection
Keywords
antiretroviral, adherence, poor antiretroviral adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Participants will receive usual clinical care, which may or may not include mental health treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive cognitive behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Intervention Description
Participants in this group will receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression.
Primary Outcome Measure Information:
Title
Microelectronic medication adherence
Time Frame
Measured at Weeks 16 and 24
Secondary Outcome Measure Information:
Title
Self-reported depression
Time Frame
Measured at Weeks 16 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn J. Wagner, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
LA Biomedical Institute at Harbor-UCLA
City
Torrance
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy
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