Overview

This trial is active, not recruiting.

Conditions stress disorders, post-traumatic, hiv infections
Treatment prolonged exposure therapy
Sponsor Kent State University
Collaborator National Institute of Mental Health (NIMH)
Start date April 2005
End date February 2009
Trial size 70 participants
Trial identifier NCT00599599, NIMH, 1 R34 MH071201-01A1, R34 MH071201-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Prolonged Exposure Therapy.
prolonged exposure therapy
Participants will meet with a therapist twice a week for 5 weeks to complete the therapy. If the therapist and participant feel more sessions are needed, an additional 8 sessions will be provided.
(No Intervention)
Weekly monitoring/Waitlist Control Group.

Primary Outcomes

Measure
PTSD symptoms
time frame: pre- & post-intervention, 3-month post, & 6-month post

Secondary Outcomes

Measure
Adherence to HIV medications
time frame: pre- & post-intervention, 3-month post, & 6-month post
Health-related Quality of Life
time frame: pre- & post-intervention, 3-month post, & 6-month post

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Intervention for PTSD, Nonadherence, and HIV Risk
Principal investigator Douglas L Delahanty, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Kent State University.