NCT07206381

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

September 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

March 4, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

September 26, 2025

Last Update Submit

January 27, 2026

Conditions

Keywords

Eye Movement Desensitization and Reprocessing (EMDR)Posttraumatic Stress Disorder (PTSD)DepressionAnxietySleep qualityquality of lifeearthquakeQEEG

Outcome Measures

Primary Outcomes (2)

  • Change in Posttraumatic Stress Symptoms (PCL-5)

    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.

    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

    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.

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

Secondary Outcomes (3)

  • 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)

Study Arms (2)

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.

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

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.

Interventions

Sessions conducted in groups with one therapist and one co-therapist; each session follows the EMDR standard protocol.

EMDR Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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: 28143760BACKGROUND
  • 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: 17284128BACKGROUND
  • 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: 14522608BACKGROUND
  • 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: 31214058BACKGROUND
  • 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: 23049852BACKGROUND
  • 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: 26579006BACKGROUND

Related Links

MeSH Terms

Conditions

Combat DisordersDepressionAnxiety DisordersSleep Initiation and Maintenance DisordersStress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization ReprocessingPsychotherapy, Group

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesSocioenvironmental Therapy

Central Study Contacts

Çiğdem Kınık, PhD

CONTACT

Önder Kavakçı, MD. Prof Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in parallel to either an EMDR intervention group or a waitlist control group. The EMDR group will receive 5-7 sessions of standardized group therapy, while the control group will not receive any intervention during the study period but will be offered EMDR after study completion
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 26, 2025

First Posted

October 3, 2025

Study Start

March 4, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

De-identified EEG data and questionnaire scores will be shared upon reasonable request after study completion, in compliance with ethical approval.