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

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RanD

Status and phase

Terminated
Phase 1

Conditions

HIV Infection
Depression

Treatments

Behavioral: Cognitive behavioral therapy (CBT)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00509340
DAHBR 9A-ASNM
R34MH077503 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7 participants in 2 patient groups

1
No Intervention group
Description:
Participants will receive usual clinical care, which may or may not include mental health treatment
2
Experimental group
Description:
Participants will receive cognitive behavioral intervention
Treatment:
Behavioral: Cognitive behavioral therapy (CBT)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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