Ireland
--:--IST
Enrolling by invitation Not applicable

The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).

NCT07112040 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2025-01-01
Last updated
2025-08-24

Condition(s) studied

Acute Stress SymptomsSexual Violence

Investigational drug(s) / intervention(s)

Behavioral - ASSYST-VS Protocol

Behavioral - ASSYST-VS Protocol: The ASSYST-SV protocol consists of three sessions, each lasting approximately 90 minutes, ideally delivered once per week over a three-week period. The intervention includes: Session 1: Psychoeducation: Explanation of typical responses to sexual trauma, providing information about the recovery process, and establishing a strong therapeutic alliance between the client and therapist. Sessions 1-3: Emotional self-regulation using trauma-sensitive yoga exercises adapted for survivors of sexual violence. Sessions 2-3: Trauma desensitization using EMDR-informed techniques, including bilateral stimulation and self-applied tools such as the Butterfly Hug. Safety procedures and closure are included in all sessions to ensure emotional containment and promote participant well-being. The intervention is delivered by trained professionals in specialized support services for victims of gender-based violence.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Universidad Complutense de Madrid Madrid Pozuelo de Alarcón
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07112040 on ClinicalTrials.gov ↗ ← All trials in Spain