Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| EMDR Europe | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in anxiety symptoms | 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. | Baseline Post-intervention (3 weeks) 3-month follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Complutense de Madrid | Madrid | Pozuelo de Alarcón | 28223 | Spain |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Changes in depression symptoms | 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. | Baseline Post-intervention (3 weeks) 3-month follow-up |
| Changes in sleep dimensions | 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. | Baseline Post-intervention (3 weeks) 3-month follow-up |
| Changes in general Impairment | 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. | Baseline Post-intervention (3 weeks) 3-month follow-up |
| Changes in wellbeing | 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. | Baseline Post-intervention (3 weeks) 3-month follow-up |
| Satisfaction with the intervention | 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. | Only after the intervention (3 weeks) |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided