Adaptation of a Intervention Protocol for Acute Post-Traumatic Stress Symptoms in Survivors of Sexual Violence: Design, Implementation, and Effectiveness in Specialized Intervention Centers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in posttraumatic stress symptoms
研究概览
简要总结
TThe main objectives of this research project are twofold: (1) to conduct a narrative review of the scientific literature on the efficacy and effectiveness of psychological interventions for reducing acute post-traumatic stress symptoms in survivors of sexual violence, and to provide a solid theoretical framework on the consequences of sexual victimization and the use of EMDR interventions in this population; and (2) to develop and test an adapted version of the ASSYST protocol of Jarero´s team for survivors of sexual violence (ASSYST-SV), evaluating its effectiveness and feasibility in reducing acute stress symptoms in women who have experienced sexual violence.
This is an exploratory quasi-experimental study with a single-group pre-post design and follow-up assessments. The intervention will be delivered to women receiving care in specialized services for survivors of gender-based violence in Catalonia and Madrid. Assessments will be conducted at three time points: pre-intervention, post-intervention, and three-month follow-up. Data will be collected through a combination of clinician-administered and self-report questionnaires.
This trial is part of a larger research project (NCT05619822) that includes several related studies. Each study addresses a specific population and/or intervention, but all share the overarching aim of examining the efficacy of a comprehensive third-generation protocol for individuals with comorbid trauma and other mental health conditions.
详细描述
Sexual violence is associated with a high risk of developing post-traumatic stress disorder (PTSD), emotional distress, sleep disturbances, and impairments in daily functioning. Despite these risks, few interventions are tailored to the specific needs of women who have experienced sexual violence, particularly in the acute phase. This study aims to address this gap by adapting the ASSYST protocol-originally developed for trauma-related acute stress-and evaluating its utility in real-world clinical settings.
The ASSYST-VS protocol consists of five 90-minute sessions. The first session focuses on psychoeducation and emotional regulation using trauma-sensitive yoga techniques (YST) to promote safety and establish a therapeutic alliance. Sessions two through five focus on desensitizing the traumatic event using an EMDR-informed version of the ASSYST protocol adapted for this population.
Given the high risk of psychopathology following sexual violence, no control group will be included for ethical reasons. Participants will be recruited from Specialized Intervention Services (SIE) in Catalonia and CAPSEM centers in Madrid. Following informed consent, participants will complete both clinician-administered and self-report assessments measuring PTSD symptoms, anxiety, depression, sleep quality, emotional well-being, and functional capacity. All study procedures will adhere to strict confidentiality protocols and comply with the General Data Protection Regulation (GDPR).
Feasibility will be assessed through adherence and dropout rates, as well as participant satisfaction. The expected sample size (n = 36) is based on previous studies with similar interventions and was calculated using G*Power to ensure adequate statistical power.
Primary outcomes include changes in PTSD symptoms (International Trauma Questionnaire, ITQ), emotional distress (Generalized Anxiety Disorder Scale, GAD-7; Patient Health Questionnaire, PHQ-9), functional impairment (Inadaptation Scale), sleep problems (Pittsburgh Sleep Quality Index, PSQI), and well-being (Warwick-Edinburgh Mental Well-being Scale, WEMWBS). Participant satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ). This project seeks to provide evidence for a scalable, early-phase trauma intervention with high clinical relevance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be a woman aged 18 or older
- •Have experienced at least one episode of sexual violence within the past 6 months
- •Be currently receiving care from one of the following centers:
- •Servei d'Intervenció Especialitzada (SIE) in Garraf-Penedès or Baix Llobregat (Catalonia)
- •CAPSEM Norte or CAPSEM Sur (Madrid)
- •Present acute post-traumatic stress symptoms (score > 0 on items 3.1 to 3.5 of the Trauma Screening Questionnaire - TSQ)
- •Be capable and willing to provide informed consent
- •Be fluent in Spanish or Catalan The intervention is offered under the assumption that women seeking support from specialized services are in need of early psychological intervention, and may benefit from a brief trauma-focused approach. This inclusive design seeks to maximize access to care and promote recovery in real-world settings.
排除标准
- •Active substance abuse that would interfere with treatment participation
- •Intellectual or cognitive disability that prevents completion of the intervention protocol
- •Active suicidal ideation at the time of the intervention
- •Inability to communicate in Spanish or Catalan
研究组 & 干预措施
ASSYST-VS Intervention
This is a single-arm study. All participants will receive the ASSYST-SV intervention, a brief, trauma-focused psychological protocol adapted for adult women who have experienced sexual violence within the previous six months. No waitlist or control condition is included due to ethical considerations.
干预措施: Behavioral - ASSYST-VS Protocol (Behavioral)
结局指标
主要结局
Change in posttraumatic stress symptoms
时间窗: Before the intervention (baseline) Immediately after the intervention (3 weeks) 3-month follow-up
International Trauma Questionnaire (ITQ; Cloitre et al., 2018) Post-Traumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD) symptoms based on ICD-11 criteria. Administration: Self-administered online via a Qualtrics link. Interpretation: Higher scores indicate greater symptom severity of PTSD and CPTSD
次要结局
- Changes in anxiety symptoms(Baseline Post-intervention (3 weeks) 3-month follow-up)
- Changes in depression symptoms(Baseline Post-intervention (3 weeks) 3-month follow-up)
- Changes in sleep dimensions(Baseline Post-intervention (3 weeks) 3-month follow-up)
- Changes in general Impairment(Baseline Post-intervention (3 weeks) 3-month follow-up)
- Changes in wellbeing(Baseline Post-intervention (3 weeks) 3-month follow-up)
- Satisfaction with the intervention(Only after the intervention (3 weeks))