Stress-Reducing Interventions in HIV+ Patients: Pilot (PEACH)

March 4, 2009 updated by: Kent State University

Pilot Intervention for PTSD, Nonadherence, and HIV Risk

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44310
        • Violet's Cupboard
      • Cleveland, Ohio, United States, 44115
        • AIDS TaskForce of Greater Cleveland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Prolonged Exposure Therapy.
Behavioral: 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: 2
Weekly monitoring/Waitlist Control Group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PTSD symptoms
Time Frame: pre- & post-intervention, 3-month post, & 6-month post
pre- & post-intervention, 3-month post, & 6-month post

Secondary Outcome Measures

Outcome Measure
Time Frame
Adherence to HIV medications
Time Frame: pre- & post-intervention, 3-month post, & 6-month post
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
pre- & post-intervention, 3-month post, & 6-month post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kent State University

Collaborators

National Institute of Mental Health (NIMH)
Summa Health System

Investigators

  • Principal Investigator: Douglas L Delahanty, PhD, Kent State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

February 1, 2010

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

January 24, 2008

Study Record Updates

Last Update Posted (Estimate)

March 5, 2009

Last Update Submitted That Met QC Criteria

March 4, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH071201-01A1 (U.S. NIH Grant/Contract)
  • NIMH, 1 R34 MH071201-01A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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