Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- CAPS-2: Clinical Administered PTSD Scale
研究概览
简要总结
EMDR (Eye Movement Desensitization and Reprocessing) is an exposure-based procedure for the treatment of patients with post-traumatic stress disorder (PTSD). Although the efficiency of EMDR-treatment is empirically proven, it remains unclear whether the bilateral stimulation triggered via eye movements has specific effects on treatment outcome. Hypothesis explaining the efficacy of the EMDR treatment are: focussing on the moving hand triggers an orientation reaction, and the duality of alertness focus during trauma exposition causes a distraction of the traumatic topic.
Within a randomized controlled study 120 patients will be treated during 8 therapeutical sessions with EMDR with bilateral stimulation or one of two control conditions: EMDR without bilateral stimulation (eyes on a fixed, unmoving hand) and exposition without any visual stimuli to focus attention on. Primary outcome are scores on an interview measure for PTSD symptoms (Clinician Administered PTSD Scale (CAPS))as assessed pre-treatment and after treatment (max 8 sessions of psychotherapy).
The following hypothesis are investigated in the study:
- EMDR treatment with bilateral stimulation through eye movements will be followed significant larger reduction in CAPS compared with EMDR treatment without bilateral stimulation (specific treatment effect of eye movements)
- EMDR with eyes fixed will be followed by a significant larger reduction in CAPS compared with EMDR without external focus (specific treatment effect of distraction)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the participant is able to reduce stress symptoms
- •no actual contact to offender
排除标准
- •drug or alcohol addiction
- •inability to tell about the traumatic events
- •cardiac problems
结局指标
主要结局
CAPS-2: Clinical Administered PTSD Scale
时间窗: 30 minutes
次要结局
- IES - Impact of Events Scale(10 minutes)
