Clinical trial NCT06758362: EMDR vs. CBT for PTSD
Official title: Comparison of EMDR Therapy and CBT for PTSD Symptoms Following the Kahramanmaraş Earthquakes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Istanbul Nisantasi University
Sponsor class: OTHER
Collaborators: name: Uskudar University
name: Beykoz University
First posted: 2025-01-03
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 24 weeks CBT Therapy Group: Weekly 50-minute sessions for 24 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.
Primary purpose: TREATMENT

Brief summary: This study compares two well-known therapies, Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT), to see which is more effective in reducing symptoms of post-traumatic stress disorder (PTSD) in people affected by the 2023 Kahramanmaraş earthquakes in Turkey. A total of 108 participants diagnosed with PTSD will be randomly assigned to one of three groups: EMDR therapy, CBT therapy, or a control group. Each participant will attend weekly, one-on-one, 50-minute online therapy sessions over 24 weeks. PTSD symptoms will be assessed at four time points: before therapy begins, mid-therapy, after therapy ends, and six months after therapy completion. The goal is to understand which therapy provides better outcomes for reducing PTSD symptoms in earthquake survivors.

Detailed description: This study aims to compare the effectiveness of two established psychotherapeutic interventions, Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT), in alleviating post-traumatic stress disorder (PTSD) symptoms among individuals affected by the 2023 Kahramanmaraş earthquakes in Turkey. These earthquakes significantly impacted 11 cities and affected approximately 10 million people, leaving many survivors with severe psychological trauma, including PTSD.

Study Objectives:

The primary objective is 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 include examining the sustainability of symptom reduction six months post-treatment and assessing treatment adherence and participant satisfaction.

Study Design:

Type: Open-label, three-arm, randomized controlled trial (RCT) Participants: 108 adults aged 18-65 years diagnosed with PTSD using the Clinician-Administered PTSD Scale (CAPS-5) and PCL-5.

Randomization: Participants will be randomly assigned to one of three groups:

EMDR Therapy Group CBT Therapy Group Control Group (No Intervention) Intervention Delivery: Weekly, 50-minute, one-on-one therapy sessions conducted online via Microsoft Teams over 24 weeks.

Intervention Details:

EMDR Therapy Group:

Structured sessions following standard EMDR protocols, including phases such as assessment, preparation, desensitization, installation, and re-evaluation.

Delivered by trained EMDR therapists: Dr. Metin Çınaroğlu and Dr. Selami Varol Ülker.

CBT Therapy Group:

Structured sessions focusing on identifying and challenging negative thought patterns, behavioral activation, and developing coping strategies.

Delivered by trained CBT therapists: Dr. Eda Yılmazer and Clinical Psychologist Ceren Odabaşı.

Control Group:

Participants in this group will not receive any therapeutic intervention but will undergo the same assessments at designated time points for comparative analysis.

Outcome Measures:

Primary Outcome Measure: Reduction in PTSD symptom severity, measured by the PCL-5 at four assessment points:

Before therapy (Baseline) Mid-therapy (After the 12th session) Post-therapy (After the 24th session) Six months post-therapy (Follow-up)

Supervision and Quality Control:

Supervision: Overall study supervision will be conducted by Prof. Dr. Gökben Hızlı Sayar.

Quality Assurance: An external committee will monitor therapy adherence and session quality throughout the intervention phase.

Ethical Considerations:

Approved by the Üsküdar University Ethical Board (Protocol Number: xxxx123). All participants will provide written informed consent and publication consent forms.

Psychiatric clearance will be obtained to ensure participants are fit for study participation.

Data Collection and Analysis:

Data will be collected at four key time points using standardized assessment tools.

Statistical analysis will include both within-group and between-group comparisons to determine intervention efficacy.

Timeline:

Participant Recruitment: January 1, 2025 - March 30, 2025 Therapy Start Date: March 15, 2025 Therapy End Date: October 30, 2025 Follow-Up Assessment: Six months after therapy completion

Expected Outcomes:

The study is expected to generate robust evidence regarding the comparative efficacy of EMDR and CBT in treating PTSD symptoms in earthquake survivors. The findings will offer valuable insights for developing evidence-based guidelines for trauma therapy in disaster-affected populations and may inform future disaster mental health intervention strategies.

This research addresses a significant gap in understanding the effectiveness of psychological interventions in post-disaster settings and aims to contribute to improving long-term mental health outcomes for affected individuals.

Eligibility 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.

Primary outcomes:
measure: Reduction in PTSD Symptom Severity Measured by the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Time Frame: Baseline (Before therapy begins) After the 12th session (Mid-therapy, approximately 12 weeks) After the 24th session (Post-therapy, approximately 24 weeks) Six months post-therapy (Follow-up, approximately 48 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Nişantaşı University
state: Maslak
Study officials:
affiliation: Üsküdar University
name: Gökben Hızlı Sayar, Prof
role: STUDY_CHAIR
References: