AI and VR Devices for Eating Behavior Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-40
SponsorIstituto per la Ricerca e l'Innovazione Biomedica
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinical diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR (APA, 2013) and ICD-11, confirmed by a public hospital setting
Body Mass Index (BMI) between 16 and 32
Disorder present for at least 6 months
No other concurrent psychotherapeutic interventions during the study
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Body-Swap for Anorexia Nervosa
Other interventionThe 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.
Emotional Rescripting for Bulimia Nervosa
Other interventionThe 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.
Standard Therapy for Anorexia Nervosa (Control)
Other interventionParticipants 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.
Standard Therapy for Bulimia Nervosa (Control)
Other interventionParticipants 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.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Intervention Group for Anorexia NervosaExperimental treatment 1 intervention
Group B: Intervention Group for Bulimia NervosaExperimental treatment 1 intervention
Group C: Control Group for Anorexia NervosaOther 1 intervention
Group D: Control Group for Bulimia NervosaOther 1 intervention
Trial outcomes
Primary outcomes
1
Eating Disorder Inventory-3 (EDI-3)
The EDI-3 is a standardized self-report questionnaire widely used to assess symptoms and psychological traits associated with the development and maintenance of eating disorders. It includes 91 items across 12 scales, using a 6-point Likert scale ranging from 0 (never) to 5 (always).
Time frame
For Bulimia Nervosa the evaluations will be at T0 (baseline),T1 (monitoring at 5 weeks), T2 (post-intervention at 9 weeks), and T3 (follow-up at 12 weeks). For Anorexia Nervosa will be at T0 (baseline), 5 weeks (T1), 9 weeks (T2), and 12 weeks (T3)2
Physical Appearance State and Trait Anxiety Scale (PASTAS)
The PASTAS is a validated measure for assessing state and trait anxiety related to body image. Participants rate their anxiety and nervousness about their physical appearance, including negative thoughts and physiological responses, on a 5-point Likert scale (0 = never, 5 = always)
Time frame
For Anorexia Nervosa the evaluation sessions will be scheduled at T0 (baseline), 5 weeks (T1), 9 weeks (T2), and 12 weeks (T3) and will last 5 minutes.3
Body Image Assessment Scale-Body Dimensions (BIAS-BD)
The BIAS-BD evaluates the perceptual and emotional components of body image dimensions. It measures the discrepancy between perceived and ideal body size (body dissatisfaction) and the discrepancy between perceived and actual body size (body distortion). It uses a range of 17 silhouettes, with different versions for males and females.
Time frame
For Anorexia Nervosa, the evaluation sessions will be scheduled at T0 (baseline), 5 weeks (T1), 9 weeks (T2), and 12 weeks (T3) and will last 15 minutes.4
Body Appreciation Scale-2 (BAS-2)
The BAS-2 is a 10-item measure that assesses body appreciation. Participants rate statements on a 5-point Likert scale (1 = never, 5 = always). Higher scores indicate greater body appreciation. Example items include "I respect my body" and "I feel comfortable in my body."
Time frame
For Anorexia Nervosa, the evaluation sessions will be scheduled at T0 (baseline), 5 weeks (T1), 9 weeks (T2), and 12 weeks (T3) and will last 10 minutes.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituto per la Ricerca e l'Innovazione Biomedica
Lead sponsor
Madre Teresa s.r.l
Collaborator
Medilink s.r.l.
Collaborator
SB SETEC S.p.A
Collaborator
Catholic University of the Sacred Heart
Collaborator
Source ClinicalTrials.gov