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.

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.

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.

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.

Time Frame:

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

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.