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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16+
SponsorCatholic University of the Sacred Heart

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: between 16-24.

Primary diagnosis of Anorexia Nervosa

BMI > 14.5

No current diagnosis or previous diagnosis for neurological disorders

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • VR -FME

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: VR-FMEExperimental treatment 1 intervention
Group B: TAUActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Eating Disorder Inventory 3

Eating Disorder Inventory 3 (EDI-3): The EDI-3 is a widely used self-report and standardized measure to assess symptomatology and psychological features relevant to developing and maintaining EDs. The third version (EDI-3) includes 91 items classified into 12 scales, with a six-point Likert scale for each answer ranging from 0 (never) to 5 (always).

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
2

Physical Appearance State and Trait Anxiety Scale

Physical Appearance State and Trait Anxiety Scale (PASTAS): The PASTAS is a reliable and valid measure for the assessment of trait and state body image anxiety. Patients had to rate, on a five-point scale ranging from 0 (never) to 5 (always), if they felt anxious or nervous about their physical appearance, including any tension, negative thoughts, and physiological responses. This tool has been previously used in research studies including Italian samples.

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
3

Body Mass Index

Body Mass Index (BMI)

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
4

Body Image Assessment Scale - Body Dimensions

The Body Image Assessment Scale-Body Dimensions (BIAS-BD): The BIAS-BD is used to assess the perceptual and emotional components of BIDs. This test assesses the discrepancy between the perceived body size and the self-determined ideal body size (to measure body dissatisfaction). Furthermore, it also reveals the discrepancy between the perceived body size and the real body size (to measure body distortion). The scale presents a range of 17 silhouettes, with different versions for women and me

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 outcomes

1

Qualitative feedback survey

Qualitative feedback from participants

Time frame
After the end of the intervention (week 4)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Catholic University of the Sacred Heart

Lead sponsor

Fatebenefratelli Hospital

Collaborator

Centro ABA Fatebenefratelli

Collaborator

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