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NCT Number: NCT06852183

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

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.

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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).

  2. 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

    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.

  3. 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 Mass Index (BMI)

  4. 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

    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

  5. 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 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).

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

Secondary outcomes

  1. Qualitative feedback survey

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

    Qualitative feedback from participants

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Brizzi, MSC

CONTACT

[email protected]

+39 3758126821

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Collaborators

  • Centro ABA Fatebenefratelli
  • Fatebenefratelli Hospital

Registry information

Acronym: VR-FME

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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