Effectiveness of an EMDR-IGTP-OTS Intervention for Posttraumatic Symptoms in Migrants Attending an Adult Education Center: 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
- 185
- 试验地点
- 1
- 主要终点
- Change in posttraumatic stress symptoms assessed by the Impact of Event Scale-Revised (IES-R)
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the effectiveness and feasibility of the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) in migrants with posttraumatic stress symptoms attending an adult education center (CPIA Salerno) in Italy.
The main questions it aims to answer are:
- Do participants who receive the EMDR-IGTP-OTS intervention show greater reductions in posttraumatic stress symptoms compared with participants assigned to a control condition?
- Does the intervention lead to improvements in psychological distress and broader psychological functioning over time?
- Is the EMDR-IGTP-OTS intervention feasible in an adult education setting, as indicated by treatment completion and adherence to the intervention protocol?
Researchers will compare participants receiving the EMDR-IGTP-OTS group intervention with participants assigned to a control condition to determine whether the intervention is effective in reducing posttraumatic stress symptoms and psychological distress.
Participants will:
- Complete questionnaires assessing posttraumatic stress symptoms and psychological distress before the intervention, after the intervention, and at follow-up.
- Participate in four structured group sessions of EMDR-IGTP-OTS delivered on consecutive days.
- Be monitored for treatment completion and protocol adherence throughout the intervention period.
详细描述
Posttraumatic stress symptoms are highly prevalent among migrants who have experienced potentially traumatic events during their life course and migration trajectories. These symptoms may negatively affect psychological functioning, adaptation, and participation in educational and social contexts. The present randomized controlled trial evaluates the effectiveness and feasibility of the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) in reducing posttraumatic stress symptoms and psychological distress among adult migrants attending an adult education center (CPIA Salerno) in Italy.
The EMDR-IGTP-OTS is a structured group intervention based on the principles of Eye Movement Desensitization and Reprocessing (EMDR), adapted for individuals exposed to ongoing traumatic stress and for group-based delivery. The intervention is designed to facilitate the processing of traumatic memories and reduce trauma-related emotional distress through standardized therapeutic procedures conducted in a group format.
Participants are randomly assigned to an intervention group receiving EMDR-IGTP-OTS or to a control condition. The study examines whether participation in the intervention is associated with greater improvements in posttraumatic stress symptoms and psychological distress compared with the control condition. Assessments are conducted before the intervention, after completion of the intervention, and at follow-up to evaluate changes over time.
The primary endpoints are between-group differences in post-intervention posttraumatic stress symptoms assessed using the Impact of Event Scale-Revised (IES-R) and the Short PTSD Rating Interview (SPRINT). Secondary endpoints include: (a) between-group differences in change scores on the Clinical Outcomes in Routine Evaluation-10 (CORE-10), a measure of global psychological distress; (b) treatment completion, defined as attendance at ≥80% of scheduled EMDR-IGTP-OTS sessions among participants assigned to the intervention condition; and (c) protocol adherence, assessed through therapist session logs documenting fidelity to each phase of the intervention protocol.
The primary hypothesis is that participants receiving EMDR-IGTP-OTS will demonstrate greater reductions in posttraumatic stress symptoms compared with participants in the control condition. Secondary hypotheses concern improvements in global psychological distress and the feasibility of delivering the intervention in an adult education setting, including treatment completion and protocol adherence.
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
No masking was used due to the nature of the behavioral intervention. Participants assigned to the EMDR-IGTP-OTS group and intervention providers were aware of treatment allocation. Investigators involved in intervention delivery were also aware of group assignment. Outcome measures were collected through standardized participant-reported questionnaires.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment in courses at CPIA Salerno (adult education center).
- •Age ≥16 years.
- •Sufficient Italian or English language proficiency to complete study procedures.
- •Provision of informed consent.
- •Clinically significant posttraumatic stress symptoms, defined as an Impact of Event Scale-Revised (IES-R) score ≥24 or a Short PTSD Rating Interview (SPRINT) score ≥14 at baseline.
排除标准
- •Current self-harm behavior or suicidal or homicidal ideation.
- •Substance abuse.
- •Psychotic disorders, bipolar disorders, or organic mental disorders.
- •Lack of adequate structural or functional support.
- •Significant cognitive impairment affecting participation in study procedures.
结局指标
主要结局
Change in posttraumatic stress symptoms assessed by the Impact of Event Scale-Revised (IES-R)
时间窗: Baseline, immediately after completion of the 4-day intervention (Day 4), and 30 days after completion of the intervention.
The Impact of Event Scale-Revised (IES-R) is a 22-item self-report measure assessing posttraumatic stress symptoms across three domains: intrusion, avoidance, and hyperarousal. Total scores range from 0 to 88, with higher scores indicating greater symptom severity.
Change in posttraumatic stress symptoms assessed by the Short PTSD Rating Interview (SPRINT)
时间窗: Baseline, immediately after completion of the 4-day intervention (Day 4), and 30 days after completion of the intervention.
The Short PTSD Rating Interview (SPRINT) is an eight-item measure assessing posttraumatic stress symptom severity, distress, and functional impairment. Total scores range from 0 to 32, with higher scores indicating greater symptom severity.
次要结局
- Change in global psychological distress assessed by the Clinical Outcomes in Routine Evaluation-10 (CORE-10)(Baseline, immediately after completion of the 4-day intervention (Day 4), and 30 days after completion of the intervention.)
- Protocol adherence to the EMDR-IGTP-OTS intervention(Assessed during each of the four consecutive intervention sessions (Days 1-4).)