Preliminary Effects of an Early EMDR Flash Group Intervention on Traumatic Stress, Anxiety, and Depressive Symptoms Among Earthquake Survivors: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Change in PTSD Symptoms (PCL-5 Total Score)
研究概览
简要总结
This pilot randomized controlled trial evaluated the preliminary effects of the online EMDR Flash Group Protocol among adults affected by the 2023 Kahramanmaraş earthquakes in Türkiye. Participants were randomly assigned to either the EMDR Flash Group Protocol or a waitlist control group. The primary outcome was change in posttraumatic stress symptoms measured by the PTSD Checklist for DSM-5 (PCL-5). Secondary outcomes included depression, anxiety, and stress symptoms measured by the Depression Anxiety Stress Scale-21 (DASS-21). Outcomes were assessed at baseline and at 3-month follow-up.
详细描述
The Kahramanmaraş earthquakes of February 2023 affected millions of people and were associated with substantial psychological distress, including posttraumatic stress, anxiety, and depressive symptoms. Early psychological interventions may help reduce acute distress and improve posttraumatic outcomes following disaster exposure.
This pilot randomized controlled trial was conducted approximately one month after the earthquakes. Adults affected by the disaster were recruited online and randomized in a 1:1 ratio to either the EMDR Flash Group Protocol intervention or a waitlist control condition. The intervention was delivered online via Zoom by trained mental health professionals using a standardized protocol consisting of two group sessions.
The primary objective was to evaluate the preliminary effects of the EMDR Flash Group Protocol on posttraumatic stress symptoms. Secondary objectives were to evaluate changes in depression, anxiety, and stress symptoms. Outcomes were assessed using self-report measures at baseline and at 3-month follow-up.
This study was conducted as a pilot trial to evaluate the feasibility and preliminary effectiveness of the intervention following a large-scale natural disaster.
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
盲法说明
Due to the nature of the intervention, participants and intervention providers were aware of group assignment after randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Present in the earthquake-affected region during the 2023 Kahramanmaraş earthquakes
- •Directly experienced the earthquake or were affected through disaster-related exposure
- •Ability to participate in online sessions
- •Access to the necessary technological equipment and internet connection
- •Ability to provide informed consent
排除标准
- •Intellectual disability
- •Current or past psychotic disorder (e.g., schizophrenia)
- •Bipolar disorder
- •History of severe head trauma
- •Inability to participate in the online intervention format
研究组 & 干预措施
EMDR Flash Group Protocol
Participants received the online EMDR Flash Group Protocol delivered by trained mental health professionals. The intervention consisted of two group sessions lasting approximately 60 to 90 minutes and was conducted via Zoom approximately one month after the 2023 Kahramanmaraş earthquakes.
干预措施: EMDR Flash Group Protocol (Behavioral)
Waitlist Control
Participants assigned to the waitlist control group did not receive the EMDR Flash Group Protocol during the study period and completed the same assessment schedule as the intervention group.
结局指标
主要结局
Change in PTSD Symptoms (PCL-5 Total Score)
时间窗: Assessed at baseline (pre-intervention) and at 3-month follow-up.
Change in posttraumatic stress symptom severity measured by the PTSD Checklist for DSM-5 (PCL-5) total score from baseline to 3-month follow-up.
次要结局
- Change in Depression Symptoms (DASS-21 Depression)(Assessed at baseline (pre-intervention) and at 3-month follow-up.)
- Change in Anxiety Symptoms (DASS-21 Anxiety)(Assessed at baseline (pre-intervention) and at 3-month follow-up.)
- Change in Stress Symptoms (DASS-21 Stress)(Assessed at baseline (pre-intervention) and at 3-month follow-up.)
研究者
Çiğdem Kınık
Assistant Professor
Istanbul Galata University