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Virtual Reality PE for Bus Bomb Survivors

This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, March 2007

Sponsors and Collaborators: Hadassah Medical Organization
University of Haifa
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00474305
  Purpose

This study will examine whether the use of a Virtual World will be effective in helping treat Posttraumatic Stress Disorder (PTSD). This is a pilot study, with five victims of bus bombings who have developed PTSD. The study will examine pre- and post-treatment levels of PTSD, anxiety, depression and day-to-day functioning.


Condition Intervention
PTSD
Behavioral: Virtual Reality Treatment for PTSD

MedlinePlus related topics:   Anxiety    Depression    Stress   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Effectiveness of Virtual Reality for Persons With PTSD Following a Bus Bombing

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: Pre and Post Treatment ]

Secondary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: Pre and Post Treatment ]
  • Activity Card Sort [ Time Frame: Pre and Post Treatment ]

Estimated Enrollment:   5
Study Start Date:   December 2007
Estimated Study Completion Date:   December 2008

Detailed Description:

PTSD can be a long-term debilitating psychiatric problem, occurring following exposure to a traumatic event. Recent studies have shown that Cognitive Behavioral Therapy is effective in the treatment of PTSD. More specifically, a protocol called Prolonged Exposure, where the patient is gradually exposed to feared stimuli, along with building a narrative of the traumatic event, has been shown to reduce PTSD and depression symptoms, both at the end of therapy (9-12 weeks) and at long term follow up.

Despite this success, some patients do not show symptom reduction with this therapy. Virtual Reality, where a real-time virtual world is created, has been successfully used to treat a variety of fears, from pain management to fear of flying. This technique has also been successfully used with patients who have not benefited from Prolonged Exposure for their PTSD, following 9/11.

This study will examine the use of a virtual reality world that involves a bus bombing. It has been created using different levels of exposure to distressing detail, such that the therapist can control the amount of exposure. The protocol is based on Prolonged Exposure, with the Virtual Reality being used to help the patient build a narrative of the event.

Five patients with PTSD following a bus bombing will be treated. They will be assessed pre and post-treatment for symptoms levels of PTSD, depression, anxiety and daily functioning. The treatment consists of 9 sessions, each lasting 90 minutes. Therapy will be supervised, and protocol adherence will be checked by an external therapist. All therapists are trained as supervisors in Prolonged Exposure.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • PTSD following a bus bombing
  • Hebrew speaking

Exclusion Criteria:

  • Other psychiatric illness
  • Other concurrent intervention
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474305

Contacts
Contact: Rena Cooper Kazaz, MD     97226777348    
Contact: Hadas Lemberg, PhD     97226777572     lhadas@hadassah.org.il    

Locations
Israel
Hadassah Medical Organization     Not yet recruiting
      Jerusalem, Israel, 91120
      Sub-Investigator: Sara A Freedman, PhD            

Sponsors and Collaborators
Hadassah Medical Organization
University of Haifa

Investigators
Study Director:     Sara A Freedman, PhD     Hadassah Medical Organization, Jerusalem, Israel    
  More Information


Publications:

Study ID Numbers:   VR-PTSD-HMO-CTIL
First Received:   May 15, 2007
Last Updated:   March 17, 2008
ClinicalTrials.gov Identifier:   NCT00474305
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
PTSD  
Prolonged Exposure  
Virtual Reality  

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on October 10, 2008




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