Stress-Reducing Interventions in HIV+ Patients: Pilot

Not Applicable

• Conditions: Stress Disorders, Post-Traumatic; HIV Infections
• Interventions: Behavioral: Prolonged Exposure Therapy

• Registration Number: NCT00599599
• Lead Sponsor: Kent State University

Brief Summary

The primary aim of this project is to examine the efficacy of prolonged exposure (PE) therapy at reducing HIV-related PTSD symptoms, increasing adherence to antiretroviral medication regimens, and increasing health-related quality of life (QOL) in HIV+ patients.

Detailed Description

HIV+ patients will be randomized to receive either PE therapy (up to 18 possible sessions) or weekly symptom monitoring (described below) and will complete measures of PTSD, adherence, and QOL pre- and post-intervention and at 3- and 6-month follow-up assessments. Secondary analyses will examine the impact of the intervention on disorders commonly comorbid with PTSD (i.e., anxiety, mood, and substance abuse/dependence disorders).

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-01-24
• Primary Completion: 2009-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-04
• Last Update Posted: 2009-03-05
• Study Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Must be HIV+
• Must meet PTSD diagnostic criteria
• Must be taking HIV medications
• Must be able to read and write in English

Exclusion Criteria

• Current or previous diagnosis of schizophrenia, any current diagnosis with psychotic features, or current suicidal ideation
• Being in a current abusive relationship or ongoing intimate relationship with one's assailant
• Mental retardation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Prolonged Exposure Therapy	Prolonged Exposure Therapy.

Primary Outcome Measures

Name	Time	Method
PTSD symptoms	pre- & post-intervention, 3-month post, & 6-month post

Secondary Outcome Measures

Name	Time	Method
Adherence to HIV medications	pre- & post-intervention, 3-month post, & 6-month post
Health-related Quality of Life	pre- & post-intervention, 3-month post, & 6-month post

Trial Locations

Locations (2)

Violet's Cupboard; 🇺🇸 Akron, Ohio, United States

AIDS Taskforce of Greater Cleveland; 🇺🇸 Cleveland, Ohio, United States