AI and VR Devices for Eating Behavior Rehabilitation

NCT06799962 | Recruiting

• 1 other identifier: CNR-IRIB-PRO-2025-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eating Disorders; Anorexia Nervosa; Bulimia Nervosa

Keywords

Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Virtual Reality; Artificial Intelligence; Body Perception; Emotional Regulation; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (10)

• 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).

  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)

  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)

  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)

  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.

  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)

  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."

  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)

  The OBCS consists of 24 items grouped into three subscales: body control, body shame, and appearance control beliefs. Each subscale includes 8 items rated on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). Subscale scores are calculated as means, with higher scores indicating greater levels of the measured variable.

  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)

  The BUT is a 34-item self-report questionnaire focusing on body dissatisfaction and body-related emotions such as anxiety, concern, and embarrassment. It comprises five subscales-weight phobia, body image concern, avoidance, compulsive self-monitoring, and depersonalization-and a general score. This tool is validated in Italian.

  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)

  The FCQ measures the intensity of food cravings both as a trait (habitual experiences) and as a state (current experiences). The FCQ-Trait comprises 39 items rated on a 6-point Likert scale (never to always), while the FCQ-State comprises 15 items rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).

  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)

  The BES is a self-report tool designed to identify and quantify the severity of Binge Eating Disorder (BED). It assesses the frequency of binge episodes, associated behaviors, and emotional experiences during and after binge eating. Higher scores indicate greater severity of BED symptoms.

  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)

  The DERS is a self-report questionnaire assessing emotional regulation abilities. The Italian short version (DERS-20) includes 20 items rated on a 5-point Likert scale (1 = almost never, 5 = almost always) and measures five dimensions: lack of acceptance, difficulty engaging in goal-directed behavior, lack of control, difficulty recognizing emotions, and reduced self-awareness. Higher scores indicate greater difficulties in emotional regulation.

  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)

  The STAI is a self-report questionnaire measuring state anxiety (temporary condition) and trait anxiety (long-standing tendency). It consists of 40 items rated on a 4-point Likert scale (almost never to almost always). Twenty items assess state anxiety (STAI-S), and 20 assess trait anxiety (STAI-T). Higher scores indicate higher levels of anxiety.

  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).

Study Arms (4)

Intervention Group for Anorexia Nervosa

EXPERIMENTAL

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.

Other: Enhanced Body-Swap for Anorexia Nervosa

Intervention Group for Bulimia Nervosa

EXPERIMENTAL

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: Emotional Rescripting for Bulimia Nervosa

Control Group for Anorexia Nervosa

OTHER

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: Standard Therapy for Anorexia Nervosa (Control)

Control Group for Bulimia Nervosa

OTHER

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.

Other: Standard Therapy for Bulimia Nervosa (Control)

Interventions

Enhanced Body-Swap for Anorexia Nervosa OTHER

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.

Intervention Group for Anorexia Nervosa

Emotional Rescripting for Bulimia Nervosa OTHER

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.

Intervention Group for Bulimia Nervosa

Standard Therapy for Anorexia Nervosa (Control) OTHER

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.

Control Group for Anorexia Nervosa

Standard Therapy for Bulimia Nervosa (Control) OTHER

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.

Control Group for Bulimia Nervosa

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Madre Teresa s.r.l: collaborator
• Medilink s.r.l.: collaborator
• SB SETEC S.p.A: collaborator
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

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

Messina, Italy, 98164, Italy

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Emotional Regulation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Flavia Marino

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavia marino

CONTACT

+393395798263; flavia.marino@irib.cnr.it

Maria Valeria Maiorana

CONTACT

+393285856656; mariavaleria.maiorana@irib.cnr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 29, 2025
• Study Start: January 30, 2025
• Primary Completion: July 30, 2025
• Study Completion: January 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)