AI and VR Devices for Eating Behavior Rehabilitation

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 15 to 40 years
• All sexes
• Healthy volunteers accepted
• Child, Adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Eating Disorders, Anorexia Nervosa, Bulimia Nervosa

Being tested

Enhanced Body-Swap for Anorexia Nervosa, Emotional Rescripting for Bulimia Nervosa, Standard Therapy for Anorexia Nervosa (Control), Standard Therapy for Bulimia Nervosa (Control)

Keywords

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

Medical subject headings

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Enhanced Body-Swap for Anorexia NervosaOther

  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 NervosaOther

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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).

   Measured: 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)

2. 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)

   Measured: 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.

3. 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.

   Measured: 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.

4. 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."

   Measured: 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.

5. 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.

   Measured: 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.

6. 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.

   Measured: 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.

7. 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).

   Measured: 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).

8. 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.

   Measured: 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).

9. 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.

   Measured: 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).

10. 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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Jan 2025
2. Study start30 Jan 2025
3. Primary completion30 Jul 2025 (estimated)
4. Study completion31 Jan 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (6)Papers the sponsor has linked to this study.
• Other trials for Eating DisordersStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.