Acute Stress SymptomsASSYST-SVNCT07112040
The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).
A study testing Behavioral - ASSYST-VS Protocol in people with Acute Stress Symptoms and Sexual Violence, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Stress Symptoms, Sexual Violence
- What is being tested?
- Behavioral - ASSYST-VS Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adaptation of a Intervention Protocol for Acute Post-Traumatic Stress Symptoms in Survivors of Sexual Violence: Design, Implementation, and Effectiveness in Specialized Intervention Centers
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.
Read the 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
- Being tested
- Behavioral - ASSYST-VS Protocol
- Keywords
- ASSYST protocol, Acute stress, trauma, individual intervention, survivors of sexual violence
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral - ASSYST-VS ProtocolBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral - ASSYST-VS Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before the intervention (baseline) Immediately after the intervention (3 weeks) 3-month follow-up
Secondary outcomes (6)
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.
Measured: Baseline Post-intervention (3 weeks) 3-month follow-up
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Only after the intervention (3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Jan 2025
- Primary completion30 Jun 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress SymptomsStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- EMDR Europe
- Responsible party
- Sponsor
- Investigators
- Carmen Valiente, Full Porfessor, Principal investigator, Universidad Complutense de MadridYolanda Ballesteros Gonzalez, PhD student, Principal investigator, Universidad Complutense de MadridRegina Espinosa, Full Porfessor, Principal investigator, Camilo Jose Cela University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112040
- Sponsor's protocol ID
- ASSYST-SV PROTOCOL
- Acronym
- ASSYST-SV
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of a Intervention Protocol for Acute Post-Traumatic Stress Symptoms in Survivors of Sexual Violence: Design, Implementation, and Effectiveness in Specialized Intervention Centers
- ClinicalTrials.gov ID
- NCT07112040
- Acronym / sponsor ID
- ASSYST-SV / ASSYST-SV PROTOCOL
- Conditions
- Acute Stress Symptoms, Sexual Violence
- Keywords
- ASSYST protocol, Acute stress, trauma, individual intervention, survivors of sexual violence
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- EMDR Europe
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ASSYST-VS Intervention | Experimental | Behavioral: Behavioral - ASSYST-VS ProtocolThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral - ASSYST-VS ProtocolThe 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. | Behavioural | ASSYST-VS Intervention |
Primary outcome
Change in posttraumatic stress symptoms
Time frame: 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
6 secondary outcomes
Changes in anxiety symptoms
Time frame: Baseline Post-intervention (3 weeks) 3-month follow-up
Changes in depression symptoms
Time frame: Baseline Post-intervention (3 weeks) 3-month follow-up
Changes in sleep dimensions
Time frame: Baseline Post-intervention (3 weeks) 3-month follow-up
Changes in general Impairment
Time frame: Baseline Post-intervention (3 weeks) 3-month follow-up
Changes in wellbeing
Time frame: Baseline Post-intervention (3 weeks) 3-month follow-up
Satisfaction with the intervention
Time frame: Only after the intervention (3 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carmen Valiente, Full Porfessor principal investigator
Universidad Complutense de Madrid
Yolanda Ballesteros Gonzalez, PhD student principal investigator
Universidad Complutense de Madrid
Regina Espinosa, Full Porfessor principal investigator
Camilo Jose Cela University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral - ASSYST-VS Protocol in people with Acute Stress Symptoms and Sexual Violence, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in posttraumatic stress symptoms (time frame: Before the intervention (baseline) Immediately after the intervention (3 weeks) 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.