Stress-Reducing Interventions in HIV+ Patients: Pilot - Full Text View

Sponsors and Collaborators:	Kent State University National Institute of Mental Health (NIMH) Summa Health System
Information provided by:	Kent State University
ClinicalTrials.gov Identifier:	NCT00599599

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

MedlinePlus related topics: AIDS Post-Traumatic Stress Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Pilot Intervention for PTSD, Nonadherence, and HIV Risk

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:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: No Intervention 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

Contacts

Contact: Douglas L Delahanty, PhD	330-672-2395	ddelahan@kent.edu
Contact: Jessica M Boarts, MA	330-672-5322	jboarts@kent.edu

Locations

United States, Ohio
AIDS Taskforce of Greater Cleveland	Recruiting
Cleveland, Ohio, United States, 44115
Contact: Chris Esmurdoc 216-621-0766 ext 224 CEsmurdoc@atfgc.org
Violet's Cupboard	Recruiting
Akron, Ohio, United States, 44310
Contact: Janaris Alston 330-375-2159

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:	Kent State University ( Douglas L. Delahanty, Professor )
Study ID Numbers:	R34 MH071201-01A1, NIMH, 1 R34 MH071201-01A1
Study First Received:	January 11, 2008
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00599599
Health Authority:	United States: Institutional Review Board

Keywords provided by Kent State University:

Prolonged Exposure Therapy
Adherence to HIV Medications
Complementary Therapies

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Anxiety Disorders
Mental Disorders
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Stress Disorders, Post-Traumatic
Stress
Retroviridae Infections
Immunologic Deficiency Syndromes
Stress Disorders, Traumatic

Additional relevant MeSH terms:

RNA Virus Infections
Pathologic Processes
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009