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

Phase 1

Terminated

• Conditions: Depression; HIV Infection
• Interventions: Behavioral: Cognitive behavioral therapy (CBT)

• Registration Number: NCT00509340
• Lead Sponsor: RAND

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-30
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Cognitive behavioral therapy (CBT)	Participants will receive cognitive behavioral intervention

Primary Outcome Measures

Name	Time	Method
Microelectronic medication adherence	Measured at Weeks 16 and 24

Secondary Outcome Measures

Name	Time	Method
Self-reported depression	Measured at Weeks 16 and 24

Trial Locations

Locations (1)

LA Biomedical Institute at Harbor-UCLA; 🇺🇸 Torrance, California, United States