AI and VR Devices for Eating Behavior Rehabilitation (ARCADIA-VR)

Istituto per la Ricerca e l'Innovazione Biomedica

Status: Enrolling

Conditions: Bulimia Nervosa; Eating Disorders; Anorexia Nervosa

Treatments: Other: Emotional Rescripting for Bulimia Nervosa; Other: Standard Therapy for Anorexia Nervosa (Control); Other: Enhanced Body-Swap for Anorexia Nervosa; Other: Standard Therapy for Bulimia Nervosa (Control)

Study type: Interventional

Funder types: Other

Identifiers

NCT06799962

CNR-IRIB-PRO-2025-001

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 15 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

Intervention Group for Anorexia Nervosa

Experimental group

Description:

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.

Treatment:

Other: Enhanced Body-Swap for Anorexia Nervosa

Intervention Group for Bulimia Nervosa

Experimental group

Description:

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.

Treatment:

Other: Emotional Rescripting for Bulimia Nervosa

Control Group for Anorexia Nervosa

Other group

Description:

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.

Treatment:

Other: Standard Therapy for Anorexia Nervosa (Control)

Control Group for Bulimia Nervosa

Other group

Description:

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.

Treatment:

Other: Standard Therapy for Bulimia Nervosa (Control)