Post Traumatic Stress Disorder PTSDEARTH-PTSDNCT06758362
EMDR vs. CBT for PTSD
A study testing Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) in people with Post Traumatic Stress Disorder PTSD, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder PTSD
- What is being tested?
- Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Online EMDR Therapy and CBT for PTSD Symptoms Following the Kahramanmaraş Earthquakes: a Randomized Controlled triaL
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.
Read the 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
- Post Traumatic Stress Disorder PTSD
- Being tested
- Eye Movement Desensitization and Reprocessing (EMDR), Cognitive Behavioral Therapy (CBT)
- Keywords
- Post-Traumatic Stress Disorder (PTSD), Eye Movement Desensitization and Reprocessing (EMDR), Cognitive Behavioral Therapy (CBT), Earthquake Survivors, Kahramanmaraş Earthquakes
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing (EMDR)Behavioural
A structured psychotherapy approach focused on reducing PTSD symptoms through guided eye movements and trauma processing.
Cognitive Behavioral Therapy (CBT)Behavioural
A psychotherapy approach focused on identifying and modifying maladaptive thought patterns and behaviors to reduce PTSD symptoms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline (pre-treatment), after session 6 (mid-treatment), and after session 12 (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Dec 2024
- Primary completion28 Mar 2025
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress Disorder PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 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.
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Nisantasi University
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University, Beykoz University
- Responsible party
- Principal investigator, Metin Çınaroğlu, Istanbul Nisantasi University
- Investigators
- Gökben Hızlı Sayar, Prof, Study chair, Üsküdar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758362
- Sponsor's protocol ID
- Nisantasi U
- Acronym
- EARTH-PTSD
- Status last verified
- Jun 2025
- First submitted
- 26 Dec 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Description: De-identified Individual Participant Data (IPD) will be shared with other researchers upon reasonable request to promote transparency, reproducibility, and further scientific exploration. The shared data will include: De-identified participant-level data for primary and secondary outcome measures Study protocol Statistical analysis plan Data Availability Timeline: Data will be made available 12 months after the publication of the primary results and will remain accessible for 5 years. Access Criteria: Researchers must submit a formal request outlining the purpose of data use, and approval will be granted by the principal investigators. Data will be shared via a secure data-sharing platform, ensuring compliance with ethical guidelines and data protection regulations. Contact Information: Requests for IPD access should be directed to the Principal Investigator, Dr. Metin Çınaroğlu, at metincinaroglu@gmail.com.
Publications
Cinaroglu M, Yilmazer E, Ulker SV, Sayar GH. Remote EMDR versus CBT for PTSD after the Kahramanmaras earthquakes: a randomized trial. Front Psychiatry. 2026 May 22;17:1779057. doi: 10.3389/fpsyt.2026.1779057. eCollection 2026.
PubMed 42254728
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Online EMDR Therapy and CBT for PTSD Symptoms Following the Kahramanmaraş Earthquakes: a Randomized Controlled triaL
- ClinicalTrials.gov ID
- NCT06758362
- Acronym / sponsor ID
- EARTH-PTSD / Nisantasi U
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Istanbul Nisantasi UniversityUniversity, hospital or other
- Collaborators
- Uskudar University, Beykoz University
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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 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.
| Arm | Type | Receives |
|---|---|---|
| EMDR Therapy Group | Active comparator | Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)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. |
| CBT Interventional Group | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT)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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR)A structured psychotherapy approach focused on reducing PTSD symptoms through guided eye movements and trauma processing. | Behavioural | EMDR Therapy Group |
| Cognitive Behavioral Therapy (CBT)A psychotherapy approach focused on identifying and modifying maladaptive thought patterns and behaviors to reduce PTSD symptoms. | Behavioural | CBT Interventional Group |
Primary outcome
Reduction in PTSD Symptom Severity Measured by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: 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.
3 secondary outcomes
Change in depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (pre-treatment), after session 6 (mid-treatment), and after session 12 (post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Derived from this study: PubMed 42254728Cinaroglu M, Yilmazer E, Ulker SV, Sayar GH. Remote EMDR versus CBT for PTSD after the Kahramanmaras earthquakes: a randomized trial. Front Psychiatry. 2026 May 22;17:1779057. doi: 10.3389/fpsyt.2026.1779057. eCollection 2026.
- Individual participant dataSharing planned: Yes. Description: De-identified Individual Participant Data (IPD) will be shared with other researchers upon reasonable request to promote transparency, reproducibility, and further scientific exploration. The shared data will include: De-identified participant-level data for primary and secondary outcome measures Study protocol Statistical analysis plan Data Availability Timeline: Data will be made available 12 months after the publication of the primary results and will remain accessible for 5 years. Access Criteria: Researchers must submit a formal request outlining the purpose of data use, and approval will be granted by the principal investigators. Data will be shared via a secure data-sharing platform, ensuring compliance with ethical guidelines and data protection regulations. Contact Information: Requests for IPD access should be directed to the Principal Investigator, Dr. Metin Çınaroğlu, at metincinaroglu@gmail.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gökben Hızlı Sayar, Prof study chair
Üsküdar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) in people with Post Traumatic Stress Disorder PTSD, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in PTSD Symptom Severity Measured by the PTSD Checklist for DSM-5 (PCL-5) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06758362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.