The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).
- Conditions
- Acute Stress SymptomsSexual Violence
- Registration Number
- NCT07112040
- Lead Sponsor
- Universidad Complutense de Madrid
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 36
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in posttraumatic stress symptoms 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
- Secondary Outcome Measures
Name Time Method Changes in anxiety symptoms Baseline Post-intervention (3 weeks) 3-month follow-up Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006; Spanish version by García-Campayo et al., 2010) Symptoms of generalized anxiety experienced over the past two weeks. Administration: Self-administered online with support available if needed. Interpretation: Higher scores indicate greater levels of generalized anxiety.
Changes in depression symptoms Baseline Post-intervention (3 weeks) 3-month follow-up Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001; Spanish version by Díez-Quevedo et al., 2001) Depressive symptoms experienced over the past two weeks. Administration: Self-administered via Qualtrics. Interpretation: Higher scores indicate more severe depressive symptoms.
Changes in sleep dimensions Baseline Post-intervention (3 weeks) 3-month follow-up Pittsburgh Sleep Quality Index - Short Version (PSQI; Buysse et al., 1989) Sleep quality and patterns, including sleep duration, latency, efficiency, disturbances, and daytime dysfunction.
Administration: Self-administered. Interpretation: Higher scores indicate poorer sleep quality.Changes in general Impairment Baseline Post-intervention (3 weeks) 3-month follow-up General Impairment Index (Índice de Inadaptación General; Echeburúa, Corral \& Fernández-Montalvo, 2000) The degree of functional impairment or maladjustment in daily life, including personal, social, and work domains.Administration: Self-administered online, with professional assistance if necessary.
Interpretation: Higher scores reflect greater difficulties in daily functioning.Changes in wellbeing Baseline Post-intervention (3 weeks) 3-month follow-up Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS; Tennant et al., 2007) Positive mental wellbeing, including positive affect, psychological functioning, and interpersonal relationships.
Administration: Self-administered via Qualtrics. Interpretation: Higher scores indicate better mental wellbeing.Satisfaction with the intervention Only after the intervention (3 weeks) Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson \& Zwick, 1982) Participant satisfaction with the intervention, including perceived effectiveness, quality, and willingness to recommend.
Administration: Self-administered online. Interpretation: Higher scores indicate greater satisfaction with the intervention.
Trial Locations
- Locations (1)
Universidad Complutense de Madrid
🇪🇸Madrid, Pozuelo De Alarcón, Spain
Universidad Complutense de Madrid🇪🇸Madrid, Pozuelo De Alarcón, Spain