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

Depression Clinical Trial

Official title:

Cognitive Behavioral Adherence Intervention for Depressed HIV Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00509340
• Other study ID #: R34MH077503
• Secondary ID: R34MH077503DAHBR
• Status: Terminated
• Phase: Phase 1
• First received: July 30, 2007
• Last updated: June 20, 2013
• Start date: June 2007
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• HIV Infection

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	LA Biomedical Institute at Harbor-UCLA	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
RAND	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microelectronic medication adherence		Measured at Weeks 16 and 24	No
Secondary	Self-reported depression		Measured at Weeks 16 and 24	Yes