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Набор скоро начнётся NCT07206381

Effects of EMDR on Psychological Symptoms and EEG Findings in Trauma-Exposed Individuals

Без фазы С лечением PTSD - Post Traumatic Stress Disorder Depression Anxiety Disorders and Symptoms Sleep Quality

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Eye Movement Desensitization and Reprocessing (EMDR) Group Therapy.
Кому может быть актуально
Состояния в реестре: PTSD - Post Traumatic Stress Disorder, Depression, Anxiety Disorders and Symptoms, Sleep Quality. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Eye Movement Desensitization and Reprocessing (EMDR) Group Therapy
    Sessions conducted in groups with one therapist and one co-therapist; each session follows the EMDR standard protocol.

Первичные конечные точки

  • Change in Posttraumatic Stress Symptoms (PCL-5) [Срок оценки: Baseline (Pre-intervention, T1; Week 0) and Post-intervention (T2; Week 6, after completion of EMDR intervention)]
  • Change in Quantitative EEG (QEEG) Power Spectral Measures [Срок оценки: Baseline (Pre-intervention, T1; Week 0) and Post-intervention (T2; Week 6, after completion of EMDR intervention)]
Вторичные конечные точки (3)
  • Change in Quality of Life (SF-36) [Срок оценки: 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) [Срок оценки: Baseline (Pre-intervention, T1; Week 0) and Post-intervention (T2; Week 6, after completion of EMDR intervention)]
  • Change in Sleep Quality (PSQI) [Срок оценки: Baseline (Pre-intervention, T1; Week 0) and Post-intervention (T2; Week 6, after completion of EMDR intervention)]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Colvonen PJ, Glassman LH, Crocker LD, Buttner MM, Orff H, Schiehser DM, Norman SB, Afari N. Pretreatment biomarkers predicting PTSD psychotherapy outcomes: A systematic review. Neurosci Biobehav Rev. 2017 Apr;75:140-156. doi: 10.1016/j.neubiorev.2017.01.027. Epub 2017 Jan 28. PMID 28143760
  • van der Kolk BA, Spinazzola J, Blaustein ME, Hopper JW, Hopper EK, Korn DL, Simpson WB. A randomized clinical trial of eye movement desensitization and reprocessing (EMDR), fluoxetine, and pill placebo in the treatment of posttraumatic stress disorder: treatment effects and long-term maintenance. J Clin Psychiatry. 2007 Jan;68(1):37-46. doi: 10.4088/jcp.v68n0105. PMID 17284128
  • Jokic-Begic N, Begic D. Quantitative electroencephalogram (qEEG) in combat veterans with post-traumatic stress disorder (PTSD). Nord J Psychiatry. 2003;57(5):351-5. doi: 10.1080/08039480310002688. PMID 14522608
  • Butt M, Espinal E, Aupperle RL, Nikulina V, Stewart JL. The Electrical Aftermath: Brain Signals of Posttraumatic Stress Disorder Filtered Through a Clinical Lens. Front Psychiatry. 2019 May 31;10:368. doi: 10.3389/fpsyt.2019.00368. eCollection 2019. PMID 31214058
  • Pagani M, Di Lorenzo G, Verardo AR, Nicolais G, Monaco L, Lauretti G, Russo R, Niolu C, Ammaniti M, Fernandez I, Siracusano A. Neurobiological correlates of EMDR monitoring - an EEG study. PLoS One. 2012;7(9):e45753. doi: 10.1371/journal.pone.0045753. Epub 2012 Sep 26. PMID 23049852
  • Pagani M, Di Lorenzo G, Monaco L, Daverio A, Giannoudas I, La Porta P, Verardo AR, Niolu C, Fernandez I, Siracusano A. Neurobiological response to EMDR therapy in clients with different psychological traumas. Front Psychol. 2015 Oct 27;6:1614. doi: 10.3389/fpsyg.2015.01614. eCollection 2015. PMID 26579006

Идентификаторы

NCT: NCT07206381 · EMDR-EEG-TR-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗