Bright Light: An Adjunct Treatment for Combat PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Clinical Global Impressions Scale (CGI)
研究概览
简要总结
The investigators are testing novel treatments for combat PTSD: bright light exposure and negation ion exposure.
详细描述
Seventy Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with posttraumatic stress disorders (PTSD) will be randomly assigned to one of two 4-week treatments (45 min/day): (1) bright light exposure or (2) a negative ion generator. Clinical assessments ,as well as self-reported measures of PTSD, anxiety, depression, and sleep will be assessed
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran of Operation Iraqi Freedom or Operation Enduring Freedom with Posttraumatic Stress Disorder
- •receiving other treatment or stopped other treatment prior to study
排除标准
- •bipolar disorder
- •psychosis
- •alcohol/drug abuse
研究组 & 干预措施
Bright Light Exposure
Bright Light (30 min/day)
干预措施: Bright Light Exposure (Other)
Negative Ion Generator
Negative Ion Generator (30 min/day)
干预措施: Negative Ion Generator (Other)
结局指标
主要结局
Clinical Global Impressions Scale (CGI)
时间窗: Baseline severity to post-treatment (4 weeks later) Change
The CGI assesses baseline severity on a 7-point scale, and change on 7-point scale. (1=normal; 4=moderately ill; 7= among the most severely ill). Change: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse
Clinical Assessed PTSD Scale (CAPS-2)
时间窗: Mean change from baseline to post-treatment (5-6 weeks later)
The CAPS-2 is administered by a trained clinician. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD.
次要结局
- Posttraumatic Stress Disorder Checklist (PCL-M)(Baseline to following 4-week treatment)