Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
89 participants
INTERVENTIONAL
2024-12-01
2025-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
This study follows an Interventional, Parallel-Group, Open-Label, Randomized Controlled Trial (RCT) design to compare the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) in reducing post-traumatic stress disorder (PTSD) symptoms among survivors of the 2023 Kahramanmaraş earthquakes.
Study Design Details:
Interventional Model: Parallel Assignment
Participants will be randomly assigned to one of three distinct groups:
EMDR Therapy Group: Weekly 50-minute sessions for 12 weeks CBT Therapy Group: Weekly 50-minute sessions for 12 weeks Control Group: No therapeutic intervention during the study period Masking: None (Open-Label) Participants and therapists will know the assigned intervention group. Purpose: Treatment To compare the therapeutic outcomes of EMDR and CBT in alleviating PTSD symptoms.
Intervention Delivery: Online, one-on-one therapy sessions using Microsoft Teams.
TREATMENT
NONE
Study Groups
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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.
Eye Movement Desensitization and Reprocessing (EMDR)
A structured psychotherapy approach focused on reducing PTSD symptoms through guided eye movements and trauma processing.
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.
Cognitive Behavioral Therapy (CBT)
A psychotherapy approach focused on identifying and modifying maladaptive thought patterns and behaviors to reduce PTSD symptoms.
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.
No interventions assigned to this group
Interventions
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Eye Movement Desensitization and Reprocessing (EMDR)
A structured psychotherapy approach focused on reducing PTSD symptoms through guided eye movements and trauma processing.
Cognitive Behavioral Therapy (CBT)
A psychotherapy approach focused on identifying and modifying maladaptive thought patterns and behaviors to reduce PTSD symptoms.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Uskudar University
OTHER
Beykoz University
OTHER
Istanbul Nisantasi University
OTHER
Responsible Party
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Metin Çınaroğlu
Assistant Professor in Psychology Department, Principle investigator
Principal Investigators
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Gökben Hızlı Sayar, Prof
Role: STUDY_CHAIR
Üsküdar University
Locations
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Nişantaşı University
Istanbul, Maslak, Turkey (Türkiye)
Countries
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Other Identifiers
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Nisantasi U
Identifier Type: -
Identifier Source: org_study_id
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