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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Kent State University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Summa Health System
Information provided by:
Kent State University
ClinicalTrials.gov Identifier:
NCT00599599
First received: January 11, 2008
Last updated: March 4, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention
Stress Disorders, Post-Traumatic
HIV Infections
 Behavioral: Prolonged Exposure Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Intervention for PTSD, Nonadherence, and HIV Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kent State University:

Primary Outcome Measures:
  • PTSD symptoms [ Time Frame: pre- & post-intervention, 3-month post, & 6-month post ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to HIV medications [ Time Frame: pre- & post-intervention, 3-month post, & 6-month post ] [ Designated as safety issue: No ]
  • Health-related Quality of Life [ Time Frame: pre- & post-intervention, 3-month post, & 6-month post ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: April 2005
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Douglas L. Delahanty, Professor, Kent State University
ClinicalTrials.gov Identifier: NCT00599599     History of Changes
Other Study ID Numbers: R34 MH071201-01A1, NIMH, 1 R34 MH071201-01A1
Study First Received: January 11, 2008
Last Updated: March 4, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013