The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).
NCT07112040 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-08-24
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
Interventions
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
EMDR Europe
collaborator INDUSTRY -
Universidad Complutense de Madrid
lead OTHER
Principal Investigators
-
Carmen Valiente, Full Porfessor · Universidad Complutense de Madrid
-
Yolanda Ballesteros Gonzalez, PhD student · Universidad Complutense de Madrid
-
Regina Espinosa, Full Porfessor · Camilo Jose Cela University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-01-01
- Primary Completion
- 2026-06-30
- Completion
- 2027-12-31
Countries
- Spain
Study Locations
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