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

Tracking Information

First Received Date ^ICMJE

July 30, 2007

Last Updated Date

March 9, 2009

Start Date ^ICMJE

June 2007

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Microelectronic medication adherence [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Microelectronic medication adherence

Change History

Complete list of historical versions of study NCT00509340 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Self-reported depression [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

self-reported depression

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Cognitive Behavioral Adherence Intervention for Depressed HIV Patients

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Depression
HIV Infection

Intervention ^ICMJE

Behavioral: Cognitive behavioral therapy (CBT)

Study Arms / Comparison Groups

No Intervention: Participants will receive usual clinical care, which may or may not include mental health treatment
Experimental: Participants will receive cognitive behavioral intervention

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Glenn J. Wagner, PhD

gwagner@rand.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00509340

Responsible Party

Glenn Wagner, RAND

Study ID Numbers ^ICMJE

R34 MH077503, DAHBR 9A-ASNM

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Glenn J. Wagner, PhD

RAND

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP