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NCT Number: NCT06799962

AI and VR Devices for Eating Behavior Rehabilitation

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.

Recruiting

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Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Messina, Italy, 98164

Location status: Recruiting

Location contact

Chiara Failla

SUB_INVESTIGATOR

Chiara Rossi

SUB_INVESTIGATOR

Fabio Frisone

SUB_INVESTIGATOR

Flavia Marino

CONTACT

[email protected]

Flavia Marino

PRINCIPAL_INVESTIGATOR

Franco Galasso

SUB_INVESTIGATOR

Gaia Roccaforte

SUB_INVESTIGATOR

Giovanni Pioggia

SUB_INVESTIGATOR

Giuseppe Farruggio

SUB_INVESTIGATOR

Giuseppe Riva

SUB_INVESTIGATOR

Renato Tino

SUB_INVESTIGATOR

Silvia Pizzoli

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. 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)

    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).

  2. 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.

    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)

  3. 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.

    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.

  4. 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.

    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."

  5. 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.

    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.

  6. 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.

    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.

  7. 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).

    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).

  8. 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).

    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.

  9. 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).

    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.

  10. 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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Flavia marino

CONTACT

[email protected]

+393395798263

Maria Valeria Maiorana

CONTACT

[email protected]

+393285856656

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Collaborators

  • Catholic University of the Sacred Heart
  • Madre Teresa s.r.l
  • Medilink s.r.l.
  • SB SETEC S.p.A

Registry information

Official study title

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

Acronym: ARCADIA-VR

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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