EMDR vs. CBT for PTSD

Not Applicable

Active, not recruiting

• Conditions: Post Traumatic Stress Disorder PTSD

• Registration Number: NCT06758362
• Lead Sponsor: Istanbul Nisantasi University

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.

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.

Study Timeline

• Study Start: 2024-12-01
• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2024-12-26
• Study First Posted: 2025-01-03
• Primary Completion: 2025-03-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-19
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in PTSD Symptom Severity Measured by the PTSD Checklist for DSM-5 (PCL-5)	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	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.
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)	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.
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)	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.

Trial Locations

Locations (1)

Nişantaşı University; 🇹🇷 İstanbul, Maslak, Turkey