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

NCT07112040 | Enrolling By Invitation

• 1 other identifier: ASSYST-SV PROTOCOL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stress Symptoms; Sexual Violence

Keywords

ASSYST protocol; Acute stress; trauma; individual intervention; survivors of sexual violence

Outcome Measures

Primary Outcomes (1)

• Change in posttraumatic stress symptoms

  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

  Before the intervention (baseline) Immediately after the intervention (3 weeks) 3-month follow-up

Secondary Outcomes (6)

• 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

Study Arms (1)

ASSYST-VS Intervention

EXPERIMENTAL

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.

Behavioral: Behavioral - ASSYST-VS Protocol

Interventions

Behavioral - ASSYST-VS Protocol BEHAVIORAL

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.

ASSYST-VS Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals who identify as women are eligible to participate in this study. This means that the study is specifically designed for women due to the nature of the support services involved and the specific focus on experiences of sexual violence. Participants must be 18 years of age or older and currently receiving care from the Specialized Intervention Service in Gender-Based Violence (SIE) in the Garraf/Penedès region of Barcelona, which is part of the Department of Feminisms and Equality of the Government of Catalonia.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• EMDR Europe: collaborator

Study Sites (1)

Universidad Complutense de Madrid

Madrid, Pozuelo de Alarcón, 28223, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Carmen Valiente, Full Porfessor

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

• Yolanda Ballesteros Gonzalez, PhD student

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

• Regina Espinosa, Full Porfessor

  Camilo Jose Cela University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, pre-post intervention study designed to evaluate the effectiveness of the ASSYST-VS protocol in reducing acute stress symptoms in women who have experienced sexual violence. Due to ethical considerations-given the high risk of psychopathology following sexual victimization-no control or waitlist group is included. Assessments are conducted at three time points: prior to the intervention (baseline), immediately after the intervention (post-treatment), and at a 3-month follow-up. The primary outcome is the reduction of acute stress symptoms. Complementary outcomes include levels of anxiety, sleep disturbances, overall mental well-being, and functional impairment. This design allows for an ethically sensitive, real-world evaluation of a brief, trauma-focused intervention in a vulnerable population.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (1)