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

NCT06852183 | Not Yet Recruiting DMC

• 1 other identifier: CNR_08/2024
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anorexia Nervosa

Keywords

Virtual Reality; Multisensory Integration; Anorexia Nervosa; Body Image

Outcome Measures

Primary Outcomes (8)

• 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).

  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

  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.

  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

  Body Mass Index (BMI)

  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

  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

  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

  Body Size Estimation Task (BES): it is a behavioral task in which participants are asked to estimate the measure of specific body parts (i.e., shoulders, hips, and waist).

  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

  Body Appreciation Scale-2 (BAS-2): The BAS-2 is a 10-item measure assessing body appreciation. Participants rate statements on Likert-type scales from 1 (never) to 5 (always). Items are averaged; higher scores indicate greater body appreciation. Example items include: "I respect my body"; "I take a positive attitude towards my body"; and "I am comfortable in my body". This tool has been validated in Italian.

  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

  Objectified Body Consciousness Scale (OBCS): The OBCS contains 24 items grouped into three subscales: body surveillance, body shame, and appearance control beliefs. Each subscale contains eight items, rated on a 7- 7-point Likert-type scale (1 =strongly disagree, 7 = strongly agree). Subscale items are averaged and higher scores indicate a greater manifestation of the particular variable measured. This tool has been validated in Italian.

  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

  Body Uneasiness Test (BUT): The BUT is a 34-item self-report questionnaire focusing on body dissatisfaction and body-related emotions such as anxiety, alarm, and embarrassment. It is composed of five subscales - weight phobia, body image concern, avoidance, compulsive self-monitoring, depersonalization - and a general score. This tool has been validated in Italian.

  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

  After the end of the intervention (week 4)

Study Arms (2)

VR-FME

EXPERIMENTAL

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.

Other: VR -FME

TAU

ACTIVE COMPARATOR

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).

Other: VR -FME

Interventions

VR -FME OTHER

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; VR-FME

Eligibility Criteria

• Age: 16 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Fatebenefratelli Hospital: collaborator
• Centro ABA Fatebenefratelli: collaborator

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Central Study Contacts

Giulia Brizzi, MSC

CONTACT

+39 3758126821; giulia.brizzi@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be randomly divided into a control group (Treatment as usual - TAU) and experimental group ( TAU + Virtual Reality intervention).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSC

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 28, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share