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Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure

No phase Interventional Anorexia Nervosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR -FME.
Who it may be relevant to
Registry conditions: Anorexia Nervosa. Basic parameters: from 16 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Background: Body image disturbance remains a core therapeutic challenge in Anorexia Nervosa (AN) treatment, necessitating innovative intervention approaches. This study protocol describes a randomized controlled trial investigating Virtual Reality Functionality-Focused Mirror Exposure (VR-FME), a novel intervention targeting the perceptual, affective, and cognitive dimensions of body image disturbance in AN patients. 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.

Interventions

  • Other 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 cons

Primary outcome measures

  • Eating Disorder Inventory 3 [Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Physical Appearance State and Trait Anxiety Scale [Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Body Mass Index [Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Body Image Assessment Scale - Body Dimensions [Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Body Size Estimation Task [Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Body Appreciation Scale-2 [Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Objectified Body Consciousness Scale [Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
  • Body Uneasiness Test [Time frame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended]
Secondary outcome measures (1)
  • Qualitative feedback survey [Time frame: After the end of the intervention (week 4)]

Eligibility criteria

Inclusion criteria

  • Age: between 16-24.
  • 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

  • Anorexia Nervosa is not a primary diagnosis
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06852183 · CNR_08/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗