NCT06991244

Brief Summary

The objective of this clinical study was to examine whether a brief EMDR 2.0 group intervention could reduce symptoms of post-traumatic stress disorder (PTSD), depression, and anxiety in adult survivors of the 2023 Türkiye earthquake. The study was conducted face-to-face in a container city in Malatya, one of the regions most severely affected by the disaster. EMDR 2.0 is an enhanced version of standard EMDR therapy that uses working memory taxation techniques to accelerate emotional processing. The primary research questions included whether EMDR 2.0 group therapy reduces PTSD symptoms in earthquake survivors, and whether it helps decrease symptoms of depression and anxiety. Participants attended three EMDR 2.0 group sessions in person over the course of one week and completed psychological assessments before the intervention, one week after, and one month after. Verbal disclosure of traumatic memories was not required during the sessions. Researchers used self-report questionnaires to evaluate changes in trauma-related distress, depression, and anxiety. This study contributes to the development of fast, accessible, and field-based psychological support strategies for communities affected by disasters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 19, 2025

Last Update Submit

May 27, 2025

Conditions

Keywords

PTSDDepressionAnxietyDisasterEarthquakeEMDR 2.0Group Intervention

Outcome Measures

Primary Outcomes (1)

  • PTSD symptom severity

    The primary outcome is the change in PTSD symptoms as measured by the PCL-5, a 20-item self-report questionnaire that assesses PTSD symptoms based on DSM-5 criteria. The scale includes four subscales: intrusion, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. Higher scores indicate greater symptom severity.

    Assessed at three time points - before the intervention (Day 0), one week after the completion of the third session (approximately Day 7), and one month after the completion (approximately Day 30)

Secondary Outcomes (3)

  • Depression symptom severity (DASS-21 Depression subscale)

    Assessed at three time points: before the intervention (Day 0), one week after completion of the third session (approximately Day 7), and one month after completion (approximately Day 30)

  • Anxiety symptom severity (DASS-21 Anxiety subscale)

    Assessed at three time points: before the intervention (Day 0), one week after completion of the third session (approximately Day 7), and one month after completion (approximately Day 30)

  • Stress symptom severity (DASS-21 Stress subscale)

    Assessed at three time points: before the intervention (Day 0), one week after completion of the third session (approximately Day 7), and one month after completion (approximately Day 30).

Study Arms (2)

EMDR 2.0 Group

EXPERIMENTAL

Participants in this group received a face-to-face EMDR 2.0 group intervention delivered over three sessions in a container city setting in Malatya, Türkiye, following the 2023 earthquake.

Behavioral: EMDR 2.0 Group Protocol

Control Group

NO INTERVENTION

Participants in this group did not receive any psychological intervention during the study period but completed the same assessments as the intervention group.

Interventions

A short-term trauma-focused group protocol adapted from EMDR 2.0, delivered in three sessions over one week, targeting PTSD, depression, and anxiety symptoms among earthquake survivors. The first session lasted 90 minutes, followed by two 60-minute sessions. The intervention was administered face-to-face in a container city in Malatya, Türkiye. All sessions were conducted by a certified EMDR therapist who had completed advanced EMDR 2.0 training.

EMDR 2.0 Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Being a survivor of the 2023 Türkiye earthquakes
  • Currently residing in a temporary container settlement in Malatya
  • Ability to attend all three face-to-face intervention sessions
  • Ability to provide informed consent
  • Sufficient cognitive and emotional capacity to complete self-report questionnaires
  • Basic literacy (reading and writing) in Turkish to understand and complete self-report scales
  • Willingness to voluntarily participate in the study

You may not qualify if:

  • Having a current diagnosis of a psychotic disorder (e.g., schizophrenia, bipolar disorder with psychotic features)
  • History of severe head trauma or neurological condition affecting cognitive capacity
  • Active suicidal ideation or risk requiring emergency psychiatric care
  • Ongoing substance dependence
  • Receiving concurrent trauma-focused psychotherapy during the study period
  • Significant hearing, vision, or language impairment interfering with participation
  • Inability to attend scheduled sessions or complete follow-up assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Teknokent Container Settlement

Battalgazi, Malatya, 44000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Alisan B Yasar, MD AssocProf

    Istanbul Gelisim University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD Researcher in Applied Psychology

Study Record Dates

First Submitted

May 19, 2025

First Posted

May 27, 2025

Study Start

October 10, 2024

Primary Completion

December 10, 2024

Study Completion

December 30, 2024

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

This study was conducted as part of a doctoral thesis project. Data sharing was not specified in the ethics committee approval. The sample is small and consists of individuals affected by a major natural disaster, living in a container settlement, making the data highly sensitive. Given the nature of the trauma-focused intervention and the emphasis on confidentiality, informed consent for IPD sharing was not obtained. Therefore, individual participant data will not be shared.

Locations