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临床试验/NCT00356278
NCT00356278已完成2 期

A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD

Emory University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
156
试验地点
1
主要终点
Clinician-Administered PTSD Scale (CAPS)

研究概览

简要总结

This study will determine whether a combination of virtual reality exposure therapy and D-cycloserine will reduce post-traumatic stress disorder symptoms in Iraq war veterans.

详细描述

Post-traumatic stress disorder (PTSD) is a type of anxiety disorder affecting people who have witnessed or experienced a traumatic event. Veterans of war are at an increased risk for developing PTSD because of their experiences with war and combat. Symptoms of PTSD often include flashbacks or nightmares, depression, anxiety or uneasiness, and feeling emotionally numb or distant toward others. Fortunately, PTSD can be treated, usually with some combination of anti-depressants, anti-anxiety medication, and therapy. Virtual reality exposure (VRE) therapy is a new type of treatment that helps people to overcome anxiety about trauma by facing situations with the use of virtual reality. D-cycloserine is a medication that has been found to enhance the effects of psychotherapy in recent studies. This study will determine the effectiveness of VRE therapy plus D-cycloserine at reducing PTSD symptoms in Iraq war veterans.

During this study, all participants will undergo one educational session and five VRE sessions. The first session will involve gathering information, learning common reactions to trauma, and participating in a breathing relaxation approach. The following five sessions will involve reviewing memories of Iraq and watching virtual Iraq sequences. Each participant will wear a head-mounted display during which they will view scenario settings such as cities, humvee convoys, and scenes related to combat. Participants will be randomly assigned to receive D-cycloserine, alprazolam (anti-anxiety drug), or placebo one half-hour before each VRE session.

Prior to the first treatment session, participants will undergo a startle reaction procedure. This will entail hearing sudden tones that last a fraction of a second, and viewing virtual reality scenes. Three small electrodes, attached to each participant's face, will measure the number of eye blinks during the procedure. At several times throughout the study, heart rate and skin conductance will also be measured with electrodes. Collection of saliva samples and measurement of blood pressure will also occur several times during this study. Before, during, and immediately after treatment, participants will complete questionnaires. Participants will be contacted 3, 6, and 12 months after treatment to assess symptoms and to schedule a time for an interview, additional questionnaires, and the virtual reality-based assessment.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Meets DSM-IV criteria for PTSD due to Iraq military trauma
  • Speaks English
  • Healthy overall

排除标准

  • History of mania, schizophrenia, or other psychoses
  • Current alcohol or drug dependence
  • Medication free within 2 weeks of study entry for any medication that has been taken less than daily for the past month and medicine free within 4 weeks of study entry for any anxiolytic medication that has been taken daily for the last month or more
  • Special medical conditions, such as kidney insufficiency, chronic diseases, or history of significant head injury
  • Stabilized on potentially data obscuring medication such as glucocorticoids

研究组 & 干预措施

C

Placebo Comparator

Participants will receive VRE therapy and placebo

干预措施: Placebo (Drug)

A

Experimental

Participants will receive VRE therapy and D-cycloserine

干预措施: D-Cycloserine (Drug)

A

Experimental

Participants will receive VRE therapy and D-cycloserine

干预措施: Virtual Reality Exposure Therapy (Behavioral)

B

Active Comparator

Participants will receive VRE therapy and alprazolam

干预措施: Alprazolam (Drug)

B

Active Comparator

Participants will receive VRE therapy and alprazolam

干预措施: Virtual Reality Exposure Therapy (Behavioral)

C

Placebo Comparator

Participants will receive VRE therapy and placebo

干预措施: Virtual Reality Exposure Therapy (Behavioral)

结局指标

主要结局

Clinician-Administered PTSD Scale (CAPS)

时间窗: Month 12

Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.

次要结局

  • PTSD Symptom Scale Self-Report(Month 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara O. Rothbaum, PhD

Professor in Psychiatry and Associate Vice Chair of Clinical Research

Emory University

研究点 (1)

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