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临床试验/NCT03000478
NCT03000478Unknown不适用

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

Bar-Ilan University, Israel2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
PTSD symptoms

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • combat related PTSD; Hebrew first language

排除标准

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

研究组 & 干预措施

Prolonged Exposure

Active Comparator

12 sessions of PE as per protocol

干预措施: Prolonged Exposure (Behavioral)

VRET

Experimental

12 sessions of Virtual Reality Exposure Therapy

干预措施: Virtual Reality Exposure Therapy (Behavioral)

结局指标

主要结局

PTSD symptoms

时间窗: 6 months post treatment

PTSD as measured by the CAPS

次要结局

未报告次要终点

研究者

发起方
Bar-Ilan University, Israel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Freedman

Dr. Sara Freedman

Bar-Ilan University, Israel

研究点 (2)

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