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NCT00599599 Clinical Trial

Stress-Reducing Interventions in HIV+ Patients: Pilot

HIV Infections Clinical Trial

— PEACH  

Official title:
Pilot Intervention for PTSD, Nonadherence, and HIV Risk

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00599599
Other study ID # R34MH071201-01A1
Secondary ID NIMH, 1 R34 MH07
Status Unknown status
Phase N/A
First received January 11, 2008
Last updated March 4, 2009
Start date April 2005
Est. completion date February 2010

Study information
Verified date March 2009
Source Kent State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Unknown status
Enrollment 70
Est. completion date February 2010
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Violet's Cupboard Akron Ohio
United States AIDS Taskforce of Greater Cleveland Cleveland Ohio

Sponsors (3)
Lead Sponsor Collaborator
Kent State University National Institute of Mental Health (NIMH), Summa Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary PTSD symptoms pre- & post-intervention, 3-month post, & 6-month post
Secondary Adherence to HIV medications pre- & post-intervention, 3-month post, & 6-month post
Secondary Health-related Quality of Life pre- & post-intervention, 3-month post, & 6-month post
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