Clinical trial NCT06852183: Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure
Official title: Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Virtual Reality
Multisensory Integration
Anorexia Nervosa
Body Image
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Fatebenefratelli Hospital
name: Centro ABA Fatebenefratelli
First posted: 2025-02-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Eating Disorder Inventory 3
timeFrame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
measure: Physical Appearance State and Trait Anxiety Scale
timeFrame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
measure: Body Mass Index
timeFrame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
measure: Body Image Assessment Scale - Body Dimensions
timeFrame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
measure: Body Size Estimation Task
timeFrame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
measure: Body Appreciation Scale-2
timeFrame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
measure: Objectified Body Consciousness Scale
timeFrame: Before the intervention, after the end of the intervention (at the end of the 4th week) and after one month after the intervention ended
measure: Body Uneasiness Test
timeFrame: 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:
measure: Qualitative feedback survey
timeFrame: After the end of the intervention (week 4)
Other outcomes:
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