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

NCT ID: NCT07112040

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-12-31

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.

Conditions

Acute Stress Symptoms; Sexual Violence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioral - ASSYST-VS Protocol

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

EMDR Europe

INDUSTRY

Sponsor Role: collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen Valiente, Full Porfessor

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Yolanda Ballesteros Gonzalez, PhD student

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Regina Espinosa, Full Porfessor

Role: PRINCIPAL_INVESTIGATOR

Camilo Jose Cela University

Locations

Universidad Complutense de Madrid

Madrid, Pozuelo de Alarcón, Spain

Countries

Spain

Other Identifiers

ASSYST-SV PROTOCOL

Identifier Type: -

Identifier Source: org_study_id