EMDR vs. CBT for PTSD (EARTH-PTSD)

Comparison of Online EMDR Therapy and CBT for PTSD Symptoms Following the Kahramanmaraş Earthquakes: a Randomized Controlled triaL

This study compares two evidence-based therapies, Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT), in reducing symptoms of post-traumatic stress disorder (PTSD) among adults affected by the 2023 Kahramanmaraş earthquakes in Türkiye. A total of 89 participants diagnosed with PTSD were randomly assigned to one of three groups: EMDR therapy, CBT therapy, or a no-treatment control group. Each participant in the treatment groups received 12 weekly, one-on-one, 50-minute therapy sessions delivered remotely via a secure online platform. PTSD and related symptoms (depression, anxiety, and emotion dysregulation) were assessed at three time points: before therapy (T1), after the 6th session (T2), and after the 12th session (T3). This study aims to evaluate which therapy yields stronger improvements in PTSD and related psychological outcomes when delivered remotely in a disaster-affected population.

Study Overview

• Status: Active, not recruiting
• Conditions: Post Traumatic Stress Disorder PTSD
• Intervention / Treatment: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR); Behavioral: Cognitive Behavioral Therapy (CBT)

Detailed Description

This randomized controlled trial aimed to compare the effectiveness of two trauma-focused psychotherapeutic interventions-Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT)-in alleviating post-traumatic stress disorder (PTSD) symptoms among adult survivors of the 2023 Kahramanmaraş earthquakes in Türkiye. These earthquakes caused large-scale devastation across 11 cities and resulted in significant psychological distress, including high rates of PTSD.

Study Objectives:

The primary objective was to determine whether EMDR or CBT is more effective in reducing PTSD symptoms, as measured by the PTSD Checklist for DSM-5 (PCL-5). Secondary objectives included examining changes in depressive symptoms, anxiety, and emotion regulation difficulties over the course of treatment.

Study Design:

This was an open-label, three-arm, randomized controlled trial. A total of 89 adult participants (aged 18-65) who met DSM-5 criteria for PTSD (based on clinical interview and PCL-5 scores) were randomly assigned to one of three groups:

EMDR Therapy Group (n = 30) CBT Therapy Group (n = 30) No-Treatment Control Group (n = 29)

Intervention Delivery:

Each participant in the therapy arms received 12 weekly, 50-minute, one-on-one sessions delivered remotely via Microsoft Teams. The control group received no intervention during the study period but underwent the same assessments.

Intervention Details:

EMDR Therapy: Delivered by certified EMDR therapists using the standard 8-phase protocol, adapted for remote delivery with visual and tactile bilateral stimulation.

CBT Therapy: Delivered by certified CBT therapists following trauma-focused CBT protocols, including psychoeducation, cognitive restructuring, and behavioral activation.

Outcome Measures:

Primary Outcome: PTSD symptoms assessed using the PCL-5 at three time points: baseline (T1), after the 6th session (T2), and after the 12th session (T3).

Secondary Outcomes: Depression (BDI-II), anxiety (BAI), and emotion regulation (DERS).

Supervision and Quality Control:

All therapists were supervised weekly by a senior psychiatrist. A fidelity monitoring committee reviewed random session recordings for quality control.

Ethical Considerations:

The study was approved by the Üsküdar University Non-Invasive Research Ethics Committee (Approval No: 61351342/020-316). Informed consent and publication consent were obtained from all participants.

Timeline:

Recruitment: January-March 2025 Intervention: April-June 2025 Follow-Up: A separate long-term follow-up is planned and will be reported in a subsequent study.

Expected Outcomes:

The study aims to provide empirical evidence on the feasibility and effectiveness of online EMDR and CBT for PTSD in disaster-affected populations, informing scalable intervention strategies for future post-disaster mental health services.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Maslak
    • İstanbul, Maslak, Turkey, 34228
      • Nişantaşı University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Eligibility Criteria

• Minimum Age: 18 Years
• Maximum Age: 65 Years
• Sex: All
• Gender Based: No
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults aged 18-65 years.
• Diagnosed with Post-Traumatic Stress Disorder (PTSD) based on the PTSD ---Checklist for DSM-5 (PCL-5) and Clinician-Administered PTSD Scale (CAPS-5).
• Resided in the Kahramanmaraş earthquake-affected region during the disaster.
• No current psychiatric medication or ongoing psychotherapy.
• No history of psychiatric disorders that may interfere with PTSD treatment (e.g., bipolar disorder, schizophrenia, substance-related disorders).
• Ability to attend weekly, one-on-one, 50-minute online therapy sessions for 24 weeks.
• Provided written informed consent and psychiatric clearance for study participation.

Exclusion Criteria:

• Individuals currently undergoing psychotherapy or using psychiatric medications.
• Diagnosis of bipolar disorder, schizophrenia, substance-related disorders, or other psychiatric conditions that may interfere with treatment.
• Inability to commit to 24 weeks of therapy sessions or attend sessions online.
• Severe cognitive impairment preventing participation in therapy.
• Failure to provide written informed consent or psychiatric clearance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EMDR Therapy Group; Arm Description: Interventional Study Participants in the EMDR Therapy Group will receive Eye Movement Desensitization and Reprocessing (EMDR) therapy, a structured, evidence-based psychotherapy approach specifically designed to alleviate symptoms of post-traumatic stress disorder (PTSD). Intervention Details: Weekly 50-minute individual online therapy sessions conducted via Microsoft Teams. A total of 12 sessions delivered over 12 weeks. Sessions will follow standard EMDR protocols, including assessment, preparation, desensitization, installation, and re-evaluation phases. Therapists: Sessions will be conducted by trained EMDR therapists: Dr. Eda Yılmazer. The primary goal is to assess the effectiveness of EMDR therapy in reducing PTSD symptoms among earthquake survivors. Therapy adherence and quality will be monitored throughout the intervention period.	Behavioral: Eye Movement Desensitization and Reprocessing (EMDR); A structured psychotherapy approach focused on reducing PTSD symptoms through guided eye movements and trauma processing.
Active Comparator: CBT Interventional Group; Arm Description: Participants in the CBT Therapy Group will receive Cognitive Behavioral Therapy (CBT), a well-established, evidence-based psychotherapy approach aimed at reducing symptoms of post-traumatic stress disorder (PTSD) by addressing maladaptive thought patterns and behaviors. Intervention Details: Weekly 50-minute individual online therapy sessions conducted via Microsoft Teams. A total of 12 sessions delivered over 12 weeks. Sessions will follow standard CBT protocols, focusing on identifying and challenging negative thought patterns, developing coping strategies, and gradually reducing trauma-related distress. Therapists: Sessions will be conducted by trained CBT therapists: Dr. Selami Varol Ülker and Dr. Metin Çınaroğlu. The primary goal is to assess the effectiveness of CBT in reducing PTSD symptoms among earthquake survivors. Therapy adherence and quality will be monitored throughout the intervention period.	Behavioral: Cognitive Behavioral Therapy (CBT); A psychotherapy approach focused on identifying and modifying maladaptive thought patterns and behaviors to reduce PTSD symptoms.
No Intervention: Control Group; Arm Description: Participants in the Control Group will not receive any therapeutic intervention during the study period. They will serve as a comparison group to evaluate the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) in reducing post-traumatic stress disorder (PTSD) symptoms. Intervention Details: No active therapy sessions will be provided. Participants will continue with their usual daily routines without any specific psychological intervention. Assessments: Participants will undergo the same PTSD symptom assessments as the intervention groups at four time points: Before the study begins (Baseline) After the 6th week (Midpoint) After the 12th week (End of study) This group will provide essential comparative data to measure the relative effectiveness of EMDR and CBT in alleviating PTSD symptoms among earthquake survivors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in PTSD Symptom Severity Measured by the PTSD Checklist for DSM-5 (PCL-5)	The primary outcome will measure changes in PTSD symptom severity using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5), a validated self-report questionnaire designed to assess PTSD symptom severity based on DSM-5 criteria. Scale Details: Minimum Score: 0 Maximum Score: 80 Score Interpretation: Higher scores indicate worse PTSD symptom severity, while lower scores indicate improvement. Assessment Time Points: Baseline (Before therapy begins) After the 6th session (Mid-therapy, approximately 6 weeks) After the 12th session (Post-therapy, approximately 12 weeks) The analysis will focus on changes in total PCL-5 scores across these time points to compare the effectiveness of EMDR and CBT therapies in addressing PTSD symptoms relative to the Control Group.	Time Frame: Baseline (Before therapy begins) After the 6th session (Mid-therapy, approximately 6 weeks) After the 12th session (Post-therapy, approximately 12 weeks) Six months post-therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II)	This secondary outcome will measure changes in depressive symptom severity using the Beck Depression Inventory-II (BDI-II), a widely used 21-item self-report questionnaire designed to assess cognitive, affective, and somatic symptoms of depression over the previous two weeks. Scale Details: Minimum Score: 0 Maximum Score: 63 Score Interpretation: Higher scores indicate more severe depressive symptoms; lower scores indicate clinical improvement. Assessment Time Points: Baseline (Before therapy begins) After the 6th session (Mid-therapy, approximately 6 weeks) After the 12th session (Post-therapy, approximately 12 weeks) The analysis will examine changes in total BDI-II scores over time to evaluate and compare the effects of EMDR and CBT on depression in earthquake survivors.	Baseline (pre-treatment), after session 6 (mid-treatment), and after session 12 (post-treatment)
Change in anxiety symptoms as measured by the Beck Anxiety Inventory (BAI)	This secondary outcome will assess changes in anxiety symptoms using the Beck Anxiety Inventory (BAI), a 21-item self-report measure that evaluates the intensity of physiological and subjective symptoms of anxiety experienced during the past week. Scale Details: Minimum Score: 0 Maximum Score: 63 Score Interpretation: Higher scores indicate greater anxiety severity; lower scores reflect symptom reduction. Assessment Time Points: Baseline (Before therapy begins) After the 6th session (Mid-therapy, approximately 6 weeks) After the 12th session (Post-therapy, approximately 12 weeks) The analysis will focus on changes in total BAI scores across these time points to compare the therapeutic outcomes of EMDR and CBT for anxiety symptoms.	Baseline (pre-treatment), after session 6 (mid-treatment), and after session 12 (post-treatment)
Change in emotion regulation difficulties as measured by the Difficulties in Emotion Regulation Scale (DERS)	This secondary outcome will measure changes in emotion regulation capacity using the Difficulties in Emotion Regulation Scale (DERS), a 36-item self-report instrument designed to assess individuals' typical levels of emotion dysregulation across six domains, including impulse control and emotional awareness. Scale Details: Minimum Score: 36 Maximum Score: 180 Score Interpretation: Higher scores indicate greater difficulties in emotion regulation; lower scores indicate better emotion regulation abilities. Assessment Time Points: Baseline (Before therapy begins) After the 6th session (Mid-therapy, approximately 6 weeks) After the 12th session (Post-therapy, approximately 12 weeks) The analysis will evaluate changes in total DERS scores to determine whether EMDR and CBT have differential effects on emotional regulation skills in the context of trauma recovery.	Baseline (pre-treatment), after session 6 (mid-treatment), and after session 12 (post-treatment)

Collaborators and Investigators

• Sponsor: Istanbul Nisantasi University
• Collaborators: Uskudar University; Beykoz University
• Investigators: Study Chair: Gökben Hızlı Sayar, Prof, Uskudar University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): March 28, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): January 3, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive Behavioral Therapy (CBT); Post-Traumatic Stress Disorder (PTSD); Kahramanmaraş Earthquakes; Eye Movement Desensitization and Reprocessing (EMDR); Earthquake Survivors
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Nisantasi U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Description:

De-identified Individual Participant Data (IPD) will be shared with other researchers upon reasonable request to promote transparency, reproducibility, and further scientific exploration. The shared data will include:

De-identified participant-level data for primary and secondary outcome measures Study protocol Statistical analysis plan

Data Availability Timeline:

Data will be made available 12 months after the publication of the primary results and will remain accessible for 5 years.

Access Criteria:

Researchers must submit a formal request outlining the purpose of data use, and approval will be granted by the principal investigators. Data will be shared via a secure data-sharing platform, ensuring compliance with ethical guidelines and data protection regulations.

Contact Information:

Requests for IPD access should be directed to the Principal Investigator, Dr. Metin Çınaroğlu, at metincinaroglu@gmail.com.

IPD Sharing Time Frame

Time Frame:

Start Date: 12 months after the publication of the primary study results End Date: 5 years after the start date

IPD Sharing Access Criteria

Who Can Access:

Researchers affiliated with academic institutions, non-profit organizations, or governmental research agencies who are conducting research aligned with the study's goals and objectives.

What Can Be Accessed:

De-identified Individual Participant Data (IPD) for all primary and secondary outcome measures.

Supporting study documents, including the study protocol, statistical analysis plan, and informed consent forms (excluding participant identifiers).

How to Access:

Interested researchers must submit a formal written request to the Principal Investigator, including:

A detailed research proposal outlining the purpose and scope of their study. Evidence of ethical approval for their research project from an accredited ethics board.

Approved requests will be granted access to the data through a secure data-sharing platform under a data use agreement (DUA) that ensures compliance with ethical guidelines and data protection standards.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No