Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure (VR-FME)

Catholic University of the Sacred Heart

Status: Begins enrollment this month

Conditions: Anorexia Nervosa

Treatments: Other: VR -FME

Study type: Interventional

Funder types: Other

Identifiers

NCT06852183

CNR_08/2024

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

VR-FME

Experimental group

Description:

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.

Treatment:

Other: VR -FME

TAU

Active Comparator group

Description:

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).

Treatment:

Other: VR -FME