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Active Not RecruitingNCT06758362

EMDR vs. CBT for PTSD

Comparison of Online EMDR Therapy and CBT for PTSD Symptoms Following the Kahramanmaraş Earthquakes: a Randomized Controlled triaL

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
89 (actual)
Sponsor
Istanbul Nisantasi University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEye Movement Desensitization and Reprocessing (EMDR)A structured psychotherapy approach focused on reducing PTSD symptoms through guided eye movements and trauma processing.
BEHAVIORALCognitive Behavioral Therapy (CBT)A psychotherapy approach focused on identifying and modifying maladaptive thought patterns and behaviors to reduce PTSD symptoms.

Timeline

Start date
2024-12-01
Primary completion
2025-03-28
Completion
2025-07-15
First posted
2025-01-03
Last updated
2025-06-19

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06758362. Inclusion in this directory is not an endorsement.