跳至主要内容
临床试验/NCT01209377
NCT01209377Unknown不适用

Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2010年4月1日最近更新:
适应症

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:

  1. 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)
  2. 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

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)

研究者

发起方
Technical University of Munich
申办方类型
Other

研究点 (2)

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