AI and VR Devices for Eating Behavior Rehabilitation

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 30, 2025

Primary Completion Date

July 30, 2025

Study Completion Date

January 31, 2026

Conditions
Eating DisordersAnorexia NervosaBulimia Nervosa
Interventions
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.

Trial Locations (1)

98164

RECRUITING

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), Messina

All Listed Sponsors
collaborator

Madre Teresa s.r.l

UNKNOWN

collaborator

Medilink s.r.l.

UNKNOWN

collaborator

SB SETEC S.p.A

UNKNOWN

collaborator

Catholic University of the Sacred Heart

OTHER

lead

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER