NCT06799962

AI and VR Devices for Eating Behavior Rehabilitation

Assistance and Rehabilitation of Eating Behavior Through Devices Based on Artificial Intelligence and Virtual Reality

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica · Academic / Other
• Sex: All
• Age: 15 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Eating disorders (ED) affect the relationship with food and body image. Virtual reality (VR), combined with artificial intelligence (AI), offers new clinical solutions, overcoming traditional cognitive behavioral therapy (CBT). The ARCADIA VR project aims to develop devices to treat ED through personalized VR systems (e.g. Enhanced Body-Swap for anorexia, Emotional Rescripting for bulimia) and AI predictive algorithms to monitor severity, risk and efficacy of treatments. These approaches promise better and faster results, improving diagnosis and treatment.

Conditions

• Eating Disorders
• Anorexia Nervosa
• Bulimia Nervosa

Interventions

Type	Name	Description
OTHER	Enhanced Body-Swap for Anorexia Nervosa	The protocol begins with a baseline session, where participants familiarize themselves with their virtual body and provide anamnesis and therapeutic efficacy baseline data. The treatment phase includes 12 bi-weekly sessions where participants embody a virtual avatar in a VR environment. During each session, the Body Mass Index (BMI) of the virtual body is incrementally increased toward a target BMI approximating normal weight (18.5). Follow-ups are conducted at 4, 8, and 12 weeks to assess long-term effects.
OTHER	Emotional Rescripting for Bulimia Nervosa	The protocol starts with an assessment phase (1 session), gathering anamnesis and baseline therapeutic efficacy data. This is followed by an evaluation phase (2 sessions), where participants rate craving responses for virtual foods and environments in immersive VR, with physiological data collected via biosensors. Using this data, a personalized exposure hierarchy is created, combining the most craving-inducing foods and environments into 40 interactive 3D scenarios. The treatment phase involves 9 VR sessions focusing on emotional regulation and craving management. Follow-ups at 4, 8, and 12 weeks evaluate progress.
OTHER	Standard Therapy for Anorexia Nervosa (Control)	Participants follow a similar structure with a baseline session to collect anamnesis and baseline data, but without VR immersion. The treatment phase consists of 12 bi-weekly sessions of standard cognitive-behavioral therapy (CBT), focusing on addressing maladaptive thought patterns, promoting healthy eating behaviors, and reducing body image disturbances. Follow-ups are conducted at 4, 8, and 12 weeks to monitor progress. No VR or AI technologies are integrated.
OTHER	Standard Therapy for Bulimia Nervosa (Control)	Participants undergo an assessment phase (1 session) to collect baseline data and an evaluation phase (2 sessions) using standard craving questionnaires without VR immersion or biosensors. The treatment phase includes 9 sessions of traditional CBT targeting binge-purge cycles and emotional triggers. Follow-ups at 4, 8, and 12 weeks monitor progress without the integration of VR or AI technologies.

Timeline

• Start date: 2025-01-30
• Primary completion: 2025-07-30
• Completion: 2026-01-31
• First posted: 2025-01-29
• Last updated: 2025-04-30

Locations

1 site across 1 country: Italy