Clinical trial NCT06839937: A Virtual Reality Couples' Intervention for Sexual Victimization Prevention: a Gender-swapping Transformative Approach
Official title: A Virtual Reality Couples' Intervention for Sexual Victimization Prevention: a Gender-swapping Transformative Approach (REVISE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexual Harassment
Gender Based Violence
Empathy
Virtual Reality Exposure Therapy
Keywords: Sexual Harassment
Gender-Based Violence
Immersive Virtual Reality
Violence Prevention
Sexism
VR Intervention
Violence Against Woman
Lead sponsor: Universitat Oberta de Catalunya
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
name: European Social Fund
First posted: 2025-02-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three independent intervention groups:

1. Identity Exchange with Exposure to Sexual Harassment: Male participants will embody their female partner's avatar in a VR harassment scenario.
2. Identity Exchange without Harassment Exposure: Male participants will embody their female partner's avatar in a neutral VR scenario.
3. Third-person Observer Condition: Male participants will observe a harassment scenario in VR without identity exchange.

Each participant remains in their assigned condition throughout the study, and comparisons are made between groups based on empathy, gender attitudes, and harassment-related responses.
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of REVISE (REalidad Virtual Inmersiva y SExualidad), an immersive virtual reality (IVR) intervention designed to promote empathy and reduce sexual harassment behaviors in heterosexual cisgender men.

The main questions that this study aims to answer are as follows.

Does experiencing gender swapping in IVR increase empathy towards survivors of sexual harassment?

Does the intervention modify attitudes toward gender roles and sexual harassment?

Researchers will compare the three experimental groups to evaluate the effects of IVR:

1. Identity Exchange Group with Exposure to Sexual Harassment: Participants embodied their partner's identity in a VR harassment scenario.
2. Identity Exchange Group without Harassment Exposure: Participants embodied their partner's identity in a neutral VR scenario.
3. Third-person Observer Group: Participants observe a harassment scenario in VR from their own perspective.

Participants will:

1. Attend one virtual reality session in a laboratory setting.
2. Undergo pre- and post-intervention assessments and a three-month follow-up.
3. Complete self-report questionnaires and physiological measures (eye tracking and pupillometry).
4. Participate in semi-structured interviews about their experiences. This study aims to explore how immersive VR embodiment can be used as a tool for gender violence prevention by fostering perspective-taking and behavioral change.

Detailed description: This study is a randomized controlled trial (RCT) designed to evaluate the efficacy of REVISE (REalidad Virtual Inmersiva y SExualidad), an immersive virtual reality (IVR) intervention, to promote empathy and reduce sexual harassment behaviors in heterosexual cisgender men. This study will assess whether experiencing sexual harassment from a first-person perspective using IVR embodiment techniques can lead to changes in attitudes and behaviors related to gender roles and sexual violence.

Study Design

* Design: Randomized controlled trial (RCT) with a 1:1:1 allocation ratio.
* Population: 90 heterosexual cisgender couples (180 participants) aged 18-39 years.
* Study Setting: This study will be conducted in a controlled laboratory environment at the Interdisciplinary Research and Innovation Hub of the Universitat Oberta de Catalunya (UOC), equipped with advanced VR and physiological tracking technologies.
* Conditions:

  1. Identity Exchange with Exposure to Sexual Harassment (Experimental Condition 1)
  2. Identity Exchange without Harassment Exposure (Experimental Condition 2) 3. Third-person Observer Condition (Control Group)
* Intervention Duration: One VR session (\~60 minutes) with pre- and post-intervention assessments and a three-month follow-up.

Intervention Procedures

1. Pre-intervention assessment

   * Participants complete self-report questionnaires measuring empathy, gender role attitudes, and harassment perceptions.
   * Baseline physiological measures (eye tracking and pupillometry) are recorded. - Participants are assigned to one of the three conditions.
2. VR Intervention:

   * Participants undergo a mirror embodiment task to establish a sense of virtual body ownership.
   * The male participant embodies his female partner's avatar in a VR scenario (conditions 1 and 2).
   * Participants experience the designated VR scenario (harassment, neutral, or observational).
   * Physiological responses are collected in real time.
3. Post-intervention assessment

   * Participants complete self-report measures to assess changes in empathy and gender attitudes.
   * Physiological data analysis (pupil dilation and eye gaze fixation) is conducted. - Semi-structured interviews explore subjective experiences.
4. Three-month follow-up:

   * Participants complete longitudinal measures to assess sustained behavioral and attitudinal changes.

Outcome Measures

1. Primary Outcome: Change in empathy scores (Interpersonal Reactivity Index). 2. Secondary Outcomes:

* Gender role attitudes (Ambivalent Sexism Inventory).
* Dyadic relationship quality and flourishing
* Harassment-related attitudes - Eye-tracking and pupillometry responses during VR.
* Qualitative insights from the post-intervention interviews.

Sample Size Justification A sample of 90 couples (180 individuals) was determined based on an estimated effect size of d = 0.5, an alpha risk of 0.05, and a power of 0.86. Participants will be randomized using block randomization (block sizes of 3 or 6) to ensure balance across the conditions.

Data Management and Quality Assurance

1. Data Collection

   * Self-reported data will be collected using secure online survey tools.
   * Physiological data will be automatically recorded using VR-compatible eye-tracking and pupillometry systems.
2. Data Validation and Security

   * The dataset will undergo automatic range checks to detect anomalies.
   * Double data entry procedures will be implemented for self-report responses.
   * Only authorized researchers will have access to identifiable data, stored on encrypted servers.
3. Missing Data Handling:

   * Missing values will be addressed using multiple imputation techniques.
   * Sensitivity analyses will be conducted to determine the impact of the missing data.

Statistical Analysis Plan

1. Primary Analysis:

   - Repeated measures ANOVA will assess within- and between-group differences in empathy scores over time.
2. Secondary Analyses:

   * Generalized Estimating Equations (GEE) will model longitudinal changes in gender attitudes.
   * Mixed-effects models will analyze physiological responses (eye tracking and pupil dilation).
   * Qualitative data from the interviews will be subjected to thematic analysis using NVivo software.

Ethical Considerations

* The study has received approval from the Research Ethics Committee of the Universitat Oberta de Catalunya.
* Participants will provide informed consent prior to participation.
* Psychological debriefing and support resources will be available to participants.

Dissemination Plan

The findings will be as follows:

* Peer-reviewed journal publications.
* Academic conferences in psychology, gender studies, and VR research.
* Open science repositories for data transparency.

Eligibility criteria: Inclusion Criteria:

* Participants must be between 18 and 39 years old.
* Couples must have been in a romantic relationship for at least six months.
* Both partners must provide explicit informed consent to participate.
* Participants must be able to read and write in Spanish to ensure comprehension of the study materials.

Exclusion Criteria:

* Individuals with any physical condition that may hinder the use of VR equipment (e.g., epilepsy or severe motion sickness).
* Individuals with a history of sexual harassment or problematic substance use, including drug or alcohol abuse.
* Individuals experiencing significant mental health difficulties that require intensive treatment.
* Participants with prior exposure to similar VR-based gender perspective-taking interventions.

Primary outcomes:
measure: Change in Empathy Scores (Interpersonal Reactivity Index - IRI)
timeFrame: Baseline, immediately post-intervention, 3-month follow-up
Secondary outcomes:
measure: Change in Gender Role Attitudes (Ambivalent Sexism Inventory - ASI)
timeFrame: Baseline, immediately post-intervention, 3-month follow-up
measure: Change in Communication Patterns (Communication Patterns Questionnaire - CPQ)
timeFrame: Baseline, immediately post-intervention, 3-month follow-up
measure: Change in Relationship Satisfaction (Dyadic Adjustment Scale - DAS)
timeFrame: Baseline, immediately post-intervention, 3-month follow-up
measure: Change in Couple Flourishing (Couple Flourishing Measure - CFM)
timeFrame: Baseline, immediately post-intervention, 3-month follow-up
measure: Change in Acceptance of Modern Myths about Sexual Aggression (AMMSA Scale)
timeFrame: Baseline, immediately post-intervention, 3-month follow-up
measure: Change in Body Ownership Illusion
timeFrame: During VR exposure at two assessment points: (1) Mirror embodiment phase (approximately 5 minutes after VR start) and (2) Farewell phase (at the end of VR exposure, approximately 15 minutes after VR start).
measure: Change in Physiological Arousal (Pupillometry)
timeFrame: From the start of VR exposure until the completion of the VR session (approximately 15 minutes). Data will be collected in real-time during this period.
measure: Change in Visual Attention (Eye-Tracking Data)
timeFrame: From the start of VR exposure until the completion of the VR session (approximately 15 minutes). Data will be collected in real-time during this period.
measure: Changes in affective responses
timeFrame: During VR exposure at one assessment point: Farewell phase (at the end of VR exposure, approximately 15 minutes after VR start).
measure: Qualitative Insights from Participant Experience
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
Study officials:
References:
citation: Carvalho J, Rosa PJ, Pereira B. Dynamic Risk Factors Characterizing Aggressive Sexual Initiation by Female College Students. J Interpers Violence. 2021 Mar;36(5-6):2455-2477. doi: 10.1177/0886260518760010. Epub 2018 Mar 5.
citation: Hollett RC, Rogers SL, Florido P, Mosdell B. Body Gaze as a Marker of Sexual Objectification: A New Scale for Pervasive Gaze and Gaze Provocation Behaviors in Heterosexual Women and Men. Arch Sex Behav. 2022 Aug;51(6):2759-2780. doi: 10.1007/s10508-022-02290-y. Epub 2022 Mar 29.
citation: Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.
citation: Ventura S, Cardenas G, Miragall M, Riva G, Banos R. How Does It Feel to Be a Woman Victim of Sexual Harassment? The Effect of 360 degrees -Video-Based Virtual Reality on Empathy and Related Variables. Cyberpsychol Behav Soc Netw. 2021 Apr;24(4):258-266. doi: 10.1089/cyber.2020.0209. Epub 2020 Oct 20.
citation: Jouriles EN, McDonald R, Kullowatz A, Rosenfield D, Gomez GS, Cuevas A. Can virtual reality increase the realism of role plays used to teach college women sexual coercion and rape-resistance skills? Behav Ther. 2009 Dec;40(4):337-45. doi: 10.1016/j.beth.2008.09.002. Epub 2008 Oct 31.
citation: Riva G, Banos RM, Botella C, Mantovani F, Gaggioli A. Transforming Experience: The Potential of Augmented Reality and Virtual Reality for Enhancing Personal and Clinical Change. Front Psychiatry. 2016 Sep 30;7:164. doi: 10.3389/fpsyt.2016.00164. eCollection 2016.
citation: Maister L, Slater M, Sanchez-Vives MV, Tsakiris M. Changing bodies changes minds: owning another body affects social cognition. Trends Cogn Sci. 2015 Jan;19(1):6-12. doi: 10.1016/j.tics.2014.11.001. Epub 2014 Dec 15.
citation: Dobbin F, Kalev A. The promise and peril of sexual harassment programs. Proc Natl Acad Sci U S A. 2019 Jun 18;116(25):12255-12260. doi: 10.1073/pnas.1818477116. Epub 2019 Jun 3.
citation: DeGue S, Valle LA, Holt MK, Massetti GM, Matjasko JL, Tharp AT. A systematic review of primary prevention strategies for sexual violence perpetration. Aggress Violent Behav. 2014 Jul-Aug;19(4):346-362. doi: 10.1016/j.avb.2014.05.004.
citation: Gunarathne L, Bhowmik J, Apputhurai P, Nedeljkovic M. Factors and consequences associated with intimate partner violence against women in low- and middle-income countries: A systematic review. PLoS One. 2023 Nov 8;18(11):e0293295. doi: 10.1371/journal.pone.0293295. eCollection 2023.
citation: Tourne Garcia M, Herrero Velazquez S, Garriga Puerto A. [Health consequences of violence against women by the couple]. Aten Primaria. 2024 Nov;56(11):102903. doi: 10.1016/j.aprim.2024.102903. Epub 2024 Mar 27. Spanish.