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

Cognitive Behavioral Adherence Intervention for Depressed HIV Patients

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00509340

Enrollment

Registered

2007-07-31

Start date

2007-06-30

Completion date

2013-06-30

Last updated

2013-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, HIV Infection

Keywords

antiretroviral, adherence, poor antiretroviral adherence

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.

Interventions

BEHAVIORALCognitive behavioral therapy (CBT)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Microelectronic medication adherence	Measured at Weeks 16 and 24

Secondary

Measure	Time frame
Self-reported depression	Measured at Weeks 16 and 24

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026