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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

• All participants with a previous diagnosis will be re-evaluated and confirmed through assessment and consent by expert professionals in the research team (i.e., a neuropsychiatrist and a clinical psychologist)

Locations
Other Locations
Italy
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
RECRUITING
Messina
Contact Information
Primary
Flavia marino
flavia.marino@irib.cnr.it
+393395798263
Backup
Maria Valeria Maiorana
mariavaleria.maiorana@irib.cnr.it
+393285856656
Time Frame
Start Date: 2025-01-30
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 80
Treatments
Experimental: Intervention Group for Anorexia Nervosa
Participants diagnosed with Anorexia Nervosa will undergo treatment enhanced with Virtual Reality (VR) and Artificial Intelligence (AI) technologies, specifically the Enhanced Body-Swap system. The intervention targets body perception and emotional regulation to address symptoms and improve treatment outcomes.
Experimental: Intervention Group for Bulimia Nervosa
Participants diagnosed with Bulimia Nervosa will receive treatment incorporating VR and AI technologies, specifically the Emotional Rescripting system. The intervention aims to modify emotional experiences and cognitive responses associated with binge-purge behaviors.
Other: Control Group for Anorexia Nervosa
Participants diagnosed with Anorexia Nervosa will follow the same therapeutic protocol as ARM 1 but without the integration of VR and AI technologies. This group serves as a comparison to assess the added value of VR and AI in treatment.
Other: Control Group for Bulimia Nervosa
Participants diagnosed with Bulimia Nervosa will follow the same therapeutic protocol as ARM 2 but without the inclusion of VR and AI technologies. This group serves as a baseline to evaluate the impact of VR and AI in treatment.
Related Therapeutic Areas
Sponsors
Collaborators: Catholic University of the Sacred Heart, Medilink s.r.l., SB SETEC S.p.A, Madre Teresa s.r.l
Leads: Istituto per la Ricerca e l'Innovazione Biomedica

This content was sourced from clinicaltrials.gov