Virtual Reality Exposure Therapy for Combat

PTSD Clinical Trial

— VRET  

Official title:

Virtual Reality Treatment for Combat Related PTSD: Is Virtual Azza More Effective Than Traditional Exposure Treatment?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03000478
• Other study ID #: BIU201216
• Status: Recruiting
• Phase: N/A
• First received: December 20, 2016
• Last updated: February 15, 2018
• Start date: December 2016
• Est. completion date: January 2019

Study information

• Verified date: February 2018
• Source: Bar-Ilan University, Israel
• Contact: Sara Freedman, PhD
• Phone: 544704636
• Email: sarafreedman[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure Therapy in adult patients with combat related PTSD.

Description:

Posttraumatic stress disorder (PTSD) affects a significant number of combat soldiers, with some studies suggesting 20% have PTSD. PTSD is related to a number of other detrimental effects, on the individual, such as mood disorders and alcohol abuse, on family members, and on society at large. Although effective treatments for PTSD exist, primarily types of cognitive behavior therapy, their uptake is very low. Studies have shown that a variety of factors act as barriers to care. These include not having the time for therapy, no therapy being locally available, and general stigma about therapy. In military populations, this stigma includes worries about the attitudes of unit members and commanding officers. As a result, many combat veterans do not seek therapy. Recently, it has been suggested that providing therapy in non-conventional settings might overcome some of these barriers. Studies over the last decade have shown that using Virtual Reality is a potential option. Virtual reality is a computer based environment that allows the therapist complete control over its multimedia components. VR is easily adaptable to exposure based treatments, where patients gradually come into contact with feared situations. VR for PTSD following combat, terror and motor vehicle accidents have all shown to be effective treatments. The studies so far are few, involve a small number of patients, and have often not adhered to gold standards of controlled trials. In addition, VR for combat in Israel has never been developed or tested.

The current study is a randomized controlled trial, that will compare traditional face-to-face treatment with Virtual Reality, for combat related PTSD. Blind assessors will examine levels of PTSD and other disorders before treatment, immediately after treatment, and at 6 month follow up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• combat related PTSD; Hebrew first language

Exclusion Criteria:

• suicidality, other psychiatric diagnosis requiring treatment, concurrent treatment,

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Prolonged Exposure

• Virtual Reality Exposure Therapy

Locations

Country	Name	City	State
Israel	Bar Ilan University	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptoms	PTSD as measured by the CAPS	6 months post treatment