Comparison of Online EMDR Therapy and CBT for PTSD Symptoms Following the Kahramanmaraş Earthquakes: a Randomized Controlled triaL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Reduction in PTSD Symptom Severity Measured by the PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Minimum Age: 18 Years
- •Maximum Age: 65 Years
- •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.
排除标准
- •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.
结局指标
主要结局
Reduction in PTSD Symptom Severity Measured by the PTSD Checklist for DSM-5 (PCL-5)
时间窗: 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.
次要结局
- 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))
- 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))
- 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))
研究者
Metin Çınaroğlu
Assistant Professor in Psychology Department, Principle investigator
Istanbul Nisantasi University