Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure
NCT ID: NCT06852183
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-06-01
2026-12-31
Brief Summary
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Methods: This single-blind, parallel-group randomized controlled trial will evaluate the efficacy of VR-FME as an adjunct to treatment as usual (TAU). Participants with AN will be randomly allocated to receive either VR-FME combined with TAU or TAU alone. The intervention specifically addresses altered body image through immersive virtual reality technology, providing controlled exposure and cognitive restructuring opportunities.
Primary Outcome: The primary outcome measure will assess changes in body image disturbance severity and core eating disorder symptomatology. We hypothesize that the integration of VR-FME with TAU will demonstrate superior therapeutic outcomes compared to TAU alone.
Significance: This protocol represents an innovative approach to addressing body image disturbance in AN, potentially enhancing current therapeutic strategies through the integration of immersive virtual reality technology. The findings will contribute to the evolving landscape of technology-enhanced interventions for eating disorders.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
PARALLEL
TREATMENT
NONE
Study Groups
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VR-FME
The VR-FME protocol integrates multiple therapeutic approaches within an immersive virtual environment. Each 60-minute session begins with embodiment induction, where participants experience synchronized multisensory stimulation to create embodiment over their virtual body. Then, various therapeutic techniques - including cognitive dissonance mirror exposure, functionality-focused mirror exposure, and compassionate body scan exercises - will be used. Each of the 8 sessions will work on a specific aspect to address different levels of body image disturbance. The intervention structure begins with an initial assessment and familiarization phase in Week 1, followed by intensive body-focused work in Weeks 2-4.
VR -FME
The VR-FME intervention specifically focuses on improving body representation and the body-self relationship by working on multisensory integration processes and embodied cognition techniques. This is thanks to the combination of immersive virtual reality experiences of body illusion combined with traditional psychological techniques. The experimental group will receive this intervention in addition to the usual treatment, which will continue as usual for the control group. The intervention consists of 8 sessions spread over 4 weeks, with 2 sessions per week.
TAU
For the entire duration of the protocol, both the experimental group (VR-FME) and the control groups will carry out the standard intervention protocol proposed by the treatment center, which consists of an outpatient program that includes weekly internal-nutritional visits, psychotherapy and NPIA assessments to also monitor the pharmacological therapy. Therefore, if the experimental group carries out the standard procedure (Treatment As Usual - TAU) in addition to the VR body image protocol (VR-FME + TAU), the control group will be subjected to the standard treatment path (TAU).
VR -FME
The VR-FME intervention specifically focuses on improving body representation and the body-self relationship by working on multisensory integration processes and embodied cognition techniques. This is thanks to the combination of immersive virtual reality experiences of body illusion combined with traditional psychological techniques. The experimental group will receive this intervention in addition to the usual treatment, which will continue as usual for the control group. The intervention consists of 8 sessions spread over 4 weeks, with 2 sessions per week.
Interventions
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VR -FME
The VR-FME intervention specifically focuses on improving body representation and the body-self relationship by working on multisensory integration processes and embodied cognition techniques. This is thanks to the combination of immersive virtual reality experiences of body illusion combined with traditional psychological techniques. The experimental group will receive this intervention in addition to the usual treatment, which will continue as usual for the control group. The intervention consists of 8 sessions spread over 4 weeks, with 2 sessions per week.
Eligibility Criteria
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Inclusion Criteria
* Primary diagnosis of Anorexia Nervosa
* BMI \> 14.5
* No current diagnosis or previous diagnosis for neurological disorders
* Females
* Fluency in Italian
* Ability to provide informed consent (and parental consent for minors)
Exclusion Criteria
* Age \< 16
* BMI \< 14.5
* Conditions that could interfere with VR use (e.g., neurological conditions, severe visual impairments, vestibular disorders)
* Males
* Substance abuse, active suicidal ideation, severe psychiatric comorbidities
* Pregrancy
* Ongoing participation in other clinical trials
* Inability to commit to the full duration of the study
16 Years
FEMALE
No
Sponsors
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Fatebenefratelli Hospital
OTHER
Centro ABA Fatebenefratelli
UNKNOWN
Catholic University of the Sacred Heart
OTHER
Responsible Party
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Giulia Brizzi
MSC
Central Contacts
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Other Identifiers
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CNR_08/2024
Identifier Type: -
Identifier Source: org_study_id