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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Participants will receive usual clinical care, which may or may not include mental health treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Participants will receive cognitive behavioral intervention

Group Type EXPERIMENTAL

Cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

Participants in this group will receive individual sessions of cognitive-behavioral training for improvement of medication adherence and reduction of depression.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No