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

Primary Purpose

Stress Disorders, Post-Traumatic, HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure Therapy
Sponsored by
Kent State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Prolonged Exposure Therapy, Adherence to HIV Medications, Complementary Therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Violet's Cupboard
  • AIDS Taskforce of Greater Cleveland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Prolonged Exposure Therapy.

Weekly monitoring/Waitlist Control Group.

Outcomes

Primary Outcome Measures

PTSD symptoms

Secondary Outcome Measures

Adherence to HIV medications
Health-related Quality of Life

Full Information

First Posted
January 11, 2008
Last Updated
March 4, 2009
Sponsor
Kent State University
Collaborators
National Institute of Mental Health (NIMH), Summa Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00599599
Brief Title
Stress-Reducing Interventions in HIV+ Patients: Pilot
Acronym
PEACH
Official Title
Pilot Intervention for PTSD, Nonadherence, and HIV Risk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kent State University
Collaborators
National Institute of Mental Health (NIMH), Summa Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, HIV Infections
Keywords
Prolonged Exposure Therapy, Adherence to HIV Medications, Complementary Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Prolonged Exposure Therapy.
Arm Title
2
Arm Type
No Intervention
Arm Description
Weekly monitoring/Waitlist Control Group.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD symptoms
Time Frame
pre- & post-intervention, 3-month post, & 6-month post
Secondary Outcome Measure Information:
Title
Adherence to HIV medications
Time Frame
pre- & post-intervention, 3-month post, & 6-month post
Title
Health-related Quality of Life
Time Frame
pre- & post-intervention, 3-month post, & 6-month post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas L Delahanty, PhD
Organizational Affiliation
Kent State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Violet's Cupboard
City
Akron
State/Province
Ohio
ZIP/Postal Code
44310
Country
United States
Facility Name
AIDS Taskforce of Greater Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Stress-Reducing Interventions in HIV+ Patients: Pilot

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