We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00599599
Recruitment Status : Unknown
Verified March 2009 by Kent State University.
Recruitment status was:  Active, not recruiting
First Posted : January 24, 2008
Last Update Posted : March 5, 2009
Sponsor:
Collaborators:
Information provided by:

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.

Condition or disease Intervention/treatment
Stress Disorders, Post-Traumatic HIV Infections Behavioral: Prolonged Exposure Therapy

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Intervention for PTSD, Nonadherence, and HIV Risk
Study Start Date : April 2005
Estimated Primary Completion Date : February 2009
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. PTSD symptoms [ Time Frame: pre- & post-intervention, 3-month post, & 6-month post ]

Secondary Outcome Measures :
  1. Adherence to HIV medications [ Time Frame: pre- & post-intervention, 3-month post, & 6-month post ]
  2. Health-related Quality of Life [ Time Frame: pre- & post-intervention, 3-month post, & 6-month post ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599599


Locations
United States, Ohio
Violet's Cupboard
Akron, Ohio, United States, 44310
AIDS Taskforce of Greater Cleveland
Cleveland, Ohio, United States, 44115
Sponsors and Collaborators
Kent State University
National Institute of Mental Health (NIMH)
Summa Health System
Investigators
Principal Investigator: Douglas L Delahanty, PhD Kent State University
More Information

Responsible Party: Douglas L. Delahanty, Professor, Kent State University
ClinicalTrials.gov Identifier: NCT00599599     History of Changes
Other Study ID Numbers: R34MH071201-01A1 ( U.S. NIH Grant/Contract )
NIMH, 1 R34 MH071201-01A1
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: March 5, 2009
Last Verified: March 2009

Keywords provided by Kent State University:
Prolonged Exposure Therapy
Adherence to HIV Medications
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Stress Disorders, Post-Traumatic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders