An interventional study of Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) in Post Traumatic Stress Disorder PTSD, sponsored by Istanbul Nisantasi University. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Istanbul Nisantasi University · Not applicable, Interventional, and Treatment
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 89 is above the median of 60 across 909 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Istanbul Nisantasi University is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
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Eligibility Criteria
Inclusion Criteria:
Exclusion Criteria:
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)
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)
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.
A structured psychotherapy approach focused on reducing PTSD symptoms through guided eye movements and trauma processing.
A psychotherapy approach focused on identifying and modifying maladaptive thought patterns and behaviors to reduce PTSD symptoms.
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: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-treatment), after session 6 (mid-treatment), and after session 12 (post-treatment)
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr, Analytic code
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Istanbul Nisantasi University