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临床试验/NCT07206381
NCT07206381尚未招募不适用

EMDR Group Therapy for Earthquake-Exposed Trauma Survivors: A Randomized Trial of Psychological and QEEG Outcomes

Istanbul Galata University0 个研究点目标入组 40 人开始时间: 2026年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Change in Posttraumatic Stress Symptoms (PCL-5)

研究概览

简要总结

This study will examine the effects of Eye Movement Desensitization and Reprocessing (EMDR) group therapy on adults who experienced the April 2025 Silivri earthquake in Turkey. Participants will be randomly assigned to either an EMDR intervention group or a waitlist control group. Psychological symptoms will be measured using the PTSD Checklist for DSM-5 (PCL-5), the Depression, Anxiety, and Stress Scale (DASS-21), the Short Form Health Survey (SF-36), and the Pittsburgh Sleep Quality Index (PSQI). Quantitative EEG (QEEG) recordings will also be collected before and after the intervention to assess changes in brain activity related to emotional regulation and trauma processing. The goal of the study is to evaluate whether EMDR produces both clinical and neurophysiological improvements in trauma-exposed individuals.

详细描述

Traumatic experiences often lead to persistent psychological symptoms such as posttraumatic stress, depression, anxiety, and sleep disturbances, which significantly impair quality of life. Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based intervention for trauma-related disorders, and growing evidence suggests that it may also produce measurable changes in brain activity. This randomized controlled trial will evaluate the effects of EMDR group therapy on both clinical outcomes and neurophysiological markers in adults exposed to the April 2025 Silivri earthquake in Turkey.

Forty participants meeting inclusion criteria will be randomly assigned to either an EMDR intervention group (20 participants) or a waitlist control group (20 participants). The intervention group will receive 5-7 sessions of standardized EMDR group therapy, delivered face-to-face by trained therapists. Quantitative EEG (QEEG) recordings will be collected at baseline and after the intervention to assess changes in spectral power, frontal alpha asymmetry, and coherence patterns. Clinical outcomes will be measured with validated self-report instruments assessing PTSD symptoms, depression, anxiety, stress, sleep quality, and overall health-related quality of life.

This study is designed to test the hypothesis that EMDR group therapy produces significant improvements in both psychological symptoms and EEG biomarkers compared to a waitlist control. By integrating subjective self-report and objective neurophysiological data, the trial aims to provide a comprehensive evaluation of EMDR's therapeutic effects in trauma-exposed populations.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Meeting DSM-5 criteria for posttraumatic stress symptoms following the April 2025 Silivri earthquake
  • Age between 18 and 50 years
  • Either medication-free for at least 1 month or on a stable dose of psychotropic medication
  • No medical contraindications for EEG recording (e.g., no epilepsy, no metal implants)

排除标准

  • Current diagnosis of schizophrenia, bipolar disorder, or a neurological disorder
  • Receiving psychotherapy
  • Inability to attend sessions regularly due to logistical or cognitive limitations

研究组 & 干预措施

EMDR Group

Experimental

Participants will receive 5-7 sessions of Eye Movement Desensitization and Reprocessing (EMDR) group therapy, delivered face-to-face by trained therapists, in line with the standard EMDR protocol. EEG measurements and psychological scales will be administered before and after the intervention.

干预措施: Eye Movement Desensitization and Reprocessing (EMDR) Group Therapy (Behavioral)

Waitlist Control

No Intervention

Participants in this arm will not receive any active psychotherapy intervention during the study period. They will undergo baseline and post-test EEG recordings and psychological assessments at the same time intervals as the experimental group. For ethical reasons, they will be offered EMDR therapy after the study is completed if requested.

结局指标

主要结局

Change in Posttraumatic Stress Symptoms (PCL-5)

时间窗: Baseline (Pre-intervention, T1; Week 0) and Post-intervention (T2; Week 6, after completion of EMDR intervention)

The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report scale measuring the severity of posttraumatic stress disorder symptoms according to DSM-5 criteria. Scores range from 0 to 80, with higher scores indicating more severe PTSD symptoms. Change in total score from baseline (pre-intervention) to post-intervention will be assessed.

Change in Quantitative EEG (QEEG) Power Spectral Measures

时间窗: Baseline (Pre-intervention, T1; Week 0) and Post-intervention (T2; Week 6, after completion of EMDR intervention)

EEG recordings will be collected using the Neuron-Spectrum-5 device according to the international 10-20 system. Power spectral analyses will be performed across frequency bands (delta, theta, alpha, beta, high beta). Changes in absolute and relative power from baseline to post-intervention will be examined.

次要结局

  • Change in Quality of Life (SF-36)(Baseline (Pre-intervention, T1; Week 0) and Post-intervention (T2; Week 6, after completion of EMDR intervention))
  • Change in Depression, Anxiety, and Stress (DASS-21)(Baseline (Pre-intervention, T1; Week 0) and Post-intervention (T2; Week 6, after completion of EMDR intervention))
  • Change in Sleep Quality (PSQI)(Baseline (Pre-intervention, T1; Week 0) and Post-intervention (T2; Week 6, after completion of EMDR intervention))

研究者

发起方
Istanbul Galata University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Çiğdem Kınık

Assistant Professor

Istanbul Galata University

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