EMDR vs. CBT for PTSD (EARTH-PTSD)

Istanbul Nisantasi University

Status: Active, not recruiting

Conditions: Post Traumatic Stress Disorder PTSD

Treatments: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR); Behavioral: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06758362

Nisantasi U

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 3 patient groups

EMDR Therapy Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)

CBT Interventional Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Control Group

No Intervention group

Description:

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.