Virtual Reality Prolonged Exposure (PE) for Bus Bomb Survivors

PTSD Clinical Trial

Official title:

Effectiveness of Virtual Reality for Persons With PTSD Following a Bus Bombing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00474305
• Other study ID #: VR-PTSD-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2007
• Last updated: December 15, 2010
• Start date: December 2007
• Est. completion date: December 2011

Study information

• Verified date: May 2010
• Source: Hadassah Medical Organization
• Contact: Rena Cooper Kazaz, MD
• Phone: 97226777348
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• PTSD following a bus bombing

• Hebrew speaking

Exclusion Criteria:

• Other psychiatric illness

• Other concurrent intervention

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Virtual Reality Treatment for PTSD
12 session protocol for Prolonged Exposure with Virtual Reality. All sessions 90 minutes.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	University of Haifa

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Difede J, Cukor J, Patt I, Giosan C, Hoffman H. The application of virtual reality to the treatment of PTSD following the WTC attack. Ann N Y Acad Sci. 2006 Jul;1071:500-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)		Pre and Post Treatment	No
Secondary	Beck Depression Inventory		Pre and Post Treatment	No
Secondary	Activity Card Sort		Pre and Post Treatment	No