EMDR vs. CBT for PTSD

NCT06758362 | Active Not Recruiting

• 1 other identifier: Nisantasi U
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder PTSD

Keywords

Post-Traumatic Stress Disorder (PTSD); Eye Movement Desensitization and Reprocessing (EMDR); Cognitive Behavioral Therapy (CBT); Earthquake Survivors; Kahramanmaraş Earthquakes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II)

  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)

  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)

  Baseline (pre-treatment), after session 6 (mid-treatment), and after session 12 (post-treatment)

Study Arms (3)

EMDR Therapy Group

ACTIVE COMPARATOR

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)

CBT Interventional Group

ACTIVE COMPARATOR

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)

Control Group

NO INTERVENTION

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.

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) BEHAVIORAL

A structured psychotherapy approach focused on reducing PTSD symptoms through guided eye movements and trauma processing.

EMDR Therapy Group

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

A psychotherapy approach focused on identifying and modifying maladaptive thought patterns and behaviors to reduce PTSD symptoms.

CBT Interventional Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Nisantasi University: lead
• Uskudar University: collaborator
• Beykoz University: collaborator

Study Sites (1)

Nişantaşı University

Istanbul, Maslak, 34228, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gökben Hızlı Sayar, Prof

  Üsküdar 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: Assistant Professor in Psychology Department, Principle investigator

Model Details: Model Description: 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.

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: December 1, 2024
• Primary Completion: March 28, 2025
• Study Completion: July 15, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Time Frame: Start Date: 12 months after the publication of the primary study results End Date: 5 years after the start date
• 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.

Locations

TU (1)