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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

January 11, 2008
March 4, 2009
April 2005
February 2009   (final data collection date for primary outcome measure)
PTSD symptoms [ Time Frame: pre- & post-intervention, 3-month post, & 6-month post ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00599599 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Stress-Reducing Interventions in HIV+ Patients: Pilot
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.

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).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • HIV Infections
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.
  • Experimental: 1
    Prolonged Exposure Therapy.
    Intervention: Behavioral: Prolonged Exposure Therapy
  • No Intervention: 2
    Weekly monitoring/Waitlist Control Group.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
February 2010
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00599599
R34 MH071201-01A1, NIMH, 1 R34 MH071201-01A1
Yes
Douglas L. Delahanty, Professor, Kent State University
Kent State University
  • National Institute of Mental Health (NIMH)
  • Summa Health System
Principal Investigator: Douglas L Delahanty, PhD Kent State University
Kent State University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP