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

Not Applicable

Not yet recruiting

• Conditions: Anorexia Nervosa

• Registration Number: NCT06852183
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Study Start: 2025-06-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Eating Disorder Inventory 3	Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended	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).
Physical Appearance State and Trait Anxiety Scale	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 (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.
Body Mass Index	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 (BMI)
Body Image Assessment Scale - Body Dimensions	Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended	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
Body Appreciation Scale-2	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 (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.
Body Uneasiness Test	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 (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.
Body Size Estimation Task	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 (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).
Objectified Body Consciousness Scale	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 (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.

Secondary Outcome Measures

Name	Time	Method
Qualitative feedback survey	After the end of the intervention (week 4)	Qualitative feedback from participants