Virtual Reality Exposure Therapy for Combat

NCT ID: NCT03000478

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-01-31

Brief Summary

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

Detailed 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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prolonged Exposure

12 sessions of PE as per protocol

Group Type: ACTIVE_COMPARATOR

Prolonged Exposure

Intervention Type: BEHAVIORAL

VRET

12 sessions of Virtual Reality Exposure Therapy

Group Type: EXPERIMENTAL

Virtual Reality Exposure Therapy

Intervention Type: BEHAVIORAL

Interventions

Prolonged Exposure

Intervention Type: BEHAVIORAL

Virtual Reality Exposure Therapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• combat related PTSD; Hebrew first language

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bar-Ilan University, Israel

OTHER

Sponsor Role: lead

Responsible Party

Sara Freedman

Dr. Sara Freedman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bar Ilan University

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Sara Freedman, PhD

Role: CONTACT

sarafreedman@gmail.com

544704636

Facility Contacts

Sara Freedman, PhD

Role: primary

sarafreedman@gmail.com

544704636

Other Identifiers

BIU201216

Identifier Type: -

Identifier Source: org_study_id