跳至主要内容
临床试验/NCT01459705
NCT01459705已完成不适用

Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD)

National Center for Telehealth and Technology2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2011年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
162
试验地点
2
主要终点
Clinician-Administered PTSD Scale (CAPS)

研究概览

简要总结

This study is evaluating the efficacy of virtual reality exposure therapy (VRET) by comparing it to prolonged exposure therapy (PE) and a waitlist(WL) group for the treatment of post traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The investigators will test the general hypothesis that 10 sessions of VRET or PE will successfully treat PTSD, therapeutically affect levels of physiological arousal, and significantly reduce perceptions of stigma toward seeking behavioral health services.

详细描述

The rationale for this study is based on growing evidence demonstrating that VRET is an efficacious treatment for PTSD and holds the potential to improve access to care for Soldiers who would otherwise avoid treatment. Although PE is considered one of the most effective cognitive-behavioral therapies (CBT) for treatments for PTSD, there are reasons why it may not be the most viable option for many Soldiers. First, prolonged exposure requires a level of emotional engagement during exposure to the trauma that many patients are unable to obtain. Second, stigma and concerns about how Soldiers will be perceived by peers and leadership has a dramatic impact on whether a Soldier will seek care. VRET may address these concerns and may also improve treatment outcomes and access to care by augmenting the patient's re-living of the trauma with a sensory-rich environment and moderating stigma perceptions by offering non-traditional treatment that is a preferable option for many Soldiers who are reluctant to seek out traditional talk therapies. Despite its promise as a viable treatment option, few studies have examined VRET for combat-related PTSD and there are no published studies that have compared VRET to PE in the treatment of combat-related PTSD. Positive results may provide new treatment options for all Soldiers, but should prove to be an especially attractive option for Soldiers who either do not respond to, or are reluctant to engage in other established therapies such as PE.

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
Single (Outcomes Assessor)

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

  • PTSD diagnosis as assessed by CAPS
  • history of deployment in support of Operation Iraqi Freedom/ Operation Enduring Freedom(OIF/OEF)
  • non sexually based deployment related trauma
  • three or more months since index trauma
  • stable on psychotropic medication for 30 days

排除标准

  • index trauma in the last three months
  • history of schizophrenia, other psychotic or bipolar disorder
  • history of organic brain disorder
  • suicidal risk or intent or self-mutilating behavior requiring hospitalization in the last 6 months
  • ongoing threatening situation
  • current drug or alcohol dependence
  • history of seizures
  • prior history of PE for PTSD
  • other current psychotherapy
  • physical condition that interferes with proper use of Virtual Reality head mounted display
  • history of loss of consciousness since entering active duty service greater than 15 minutes history of schizophrenia, other psychotic or bipolar disorder

结局指标

主要结局

Clinician-Administered PTSD Scale (CAPS)

时间窗: 26 Week follow up

The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.

次要结局

  • Suicide Risk Assessment(26 Week follow up)
  • Perceived Stigma Measure (PSS)(26 week follow up)
  • Beck Anxiety Inventory (BAI)(26 week follow up)
  • Side Effects Questionnaire(Treatment session 10 (week 5))
  • BASIS-24(26 week follow up)
  • Subjective Units of Distress (SUDs)(Treatment session 10 (week 5))
  • PTSD Checklist (PCL-C)(26 week follow up)
  • Primary Care PTSD Screen (PC-PTSD)(26 Week follow up)
  • Beck Depression Inventory-II (BDI-II)(26 Week follow up)
  • Intent to Attend(2.5 weeks (or after treatment session 5))
  • PTSD Checklist- Civilian (PCL-C)(Screening Visit (Day 1))
  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)(26 Week follow up)
  • Behavior and Sympton Identification Scale (BASIS-24)(Screening Visit(Day 1))

研究者

发起方
National Center for Telehealth and Technology
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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