AI and VR Devices for Eating Behavior Rehabilitation

Official title

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

Overview

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.

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-
• 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
• 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.

Primary outcome measures

• Eating Disorder Inventory-3 (EDI-3) [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)]
• Physical Appearance State and Trait Anxiety Scale (PASTAS) [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.]
• Body Image Assessment Scale-Body Dimensions (BIAS-BD) [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.]
• Body Appreciation Scale-2 (BAS-2) [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.]
• Objectified Body Consciousness Scale (OBCS) [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.]
• Body Uneasiness Test (BUT) [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.]
• Food Craving Questionnaire (FCQ) [Time frame: For Bulimia Nervosa the evaluation session will be divided into three moments and will last 15 minutes. The proposed evaluation moments are T0 (baseline), T1 (monitoring at 5 weeks), T2 (post-intervention at 9 weeks), and T3 (follow-up at 12 weeks).]
• Binge Eating Scale (BES) [Time frame: For Bulimia Nervosa the evaluation session will be divided into three moments and will last 5 minutes. The proposed evaluation moments are T0 (baseline), T1 (monitoring at 5 weeks), T2 (post-intervention at 9 weeks), and T3 (follow-up at 12 weeks).]
• Difficulties in Emotional Regulation Scale (DERS-20) [Time frame: For Bulimia Nervosa the evaluation session will be divided into three moments and will last 10 minutes. The proposed evaluation moments are T0 (baseline), T1 (monitoring at 5 weeks), T2 (post-intervention at 9 weeks), and T3 (follow-up at 12 weeks).]
• State and Trait Anxiety Inventory (STAI) [Time frame: For Bulimia Nervosa the evaluation session will be divided into three moments and will last 20 minutes. The proposed evaluation moments are T0 (baseline), T1 (monitoring at 5 weeks), T2 (post-intervention at 9 weeks), and T3 (follow-up at 12 weeks).]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

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

Publications

• Brown T, Nauman Vogel E, Adler S, Bohon C, Bullock K, Nameth K, Riva G, Safer DL, Runfola CD. Bringing Virtual Reality From Clinical Trials to Clinical Practice for the Treatment of Eating Disorders: An Example Using Virtual Reality Cue Exposure Therapy. J Med Internet Res. 2020 Apr 23;22(4):e16386. doi: 10.2196/16386. PMID 32324145
• Demartini B, Goeta D, Romito L, Anselmetti S, Bertelli S, D'Agostino A, Gambini O. Anorexia Nervosa and Functional Motor Symptoms: Two Faces of the Same Coin? J Neuropsychiatry Clin Neurosci. 2017 Fall;29(4):383-390. doi: 10.1176/appi.neuropsych.16080156. Epub 2017 May 31. PMID 28558480
• Colombo D, Diaz-Garcia A, Fernandez-Alvarez J, Botella C. Virtual reality for the enhancement of emotion regulation. Clin Psychol Psychother. 2021 May;28(3):519-537. doi: 10.1002/cpp.2618. Epub 2021 Jun 23. PMID 34048621
• Clus D, Larsen ME, Lemey C, Berrouiguet S. The Use of Virtual Reality in Patients with Eating Disorders: Systematic Review. J Med Internet Res. 2018 Apr 27;20(4):e157. doi: 10.2196/jmir.7898. PMID 29703715
• Boeldt D, McMahon E, McFaul M, Greenleaf W. Using Virtual Reality Exposure Therapy to Enhance Treatment of Anxiety Disorders: Identifying Areas of Clinical Adoption and Potential Obstacles. Front Psychiatry. 2019 Oct 25;10:773. doi: 10.3389/fpsyt.2019.00773. eCollection 2019. PMID 31708821
• Badoud D, Tsakiris M. From the body's viscera to the body's image: Is there a link between interoception and body image concerns? Neurosci Biobehav Rev. 2017 Jun;77:237-246. doi: 10.1016/j.neubiorev.2017.03.017. Epub 2017 Apr 1. PMID 28377099

Identifiers

NCT: NCT06799962 · CNR-IRIB-PRO-2025-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗