An interventional study of Enhanced Body-Swap for Anorexia Nervosa and Emotional Rescripting for Bulimia Nervosa in Eating Disorders, Anorexia Nervosa and Bulimia Nervosa, sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. Recruiting at 1 site in Italy. Open to participants aged 15 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Istituto per la Ricerca e l'Innovazione Biomedica · Not applicable, Interventional, and Treatment
Among 28 studies in Feeding and Eating Disorders with a site in Italy — 13 open to participants now, 14 under way, none of them phase 3. Feeding and Eating Disorders · Italy.
Among the 28 studies in Feeding and Eating Disorders with a site in Italy, this one is the 6th largest by planned enrollment of the 18 interventional ones that give a count, is one of 5 that started in 2025, is one of 18 with no phase, reaches primary completion later than 2 of the 13 other live ones, and was the 17th registered.
645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.
Browse Feeding and Eating Disorders studies →13 of the 28 studies in Feeding and Eating Disorders with a site in Italy are open now. Recruiting first, the newest first:
University of Bologna · Sites in Italy
Ages 18–40 · Healthy volunteers
University of Palermo · Sites in Italy
Ages 18+
Istituto Auxologico Italiano · Sites in Italy
Ages 16–65
University of Pavia · Sites in Italy
Ages 18+ · Healthy volunteers
University of Padova · Sites in Italy
Ages 14+ · Women only
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 101 Feeding and Eating Disorders studies recruiting now, 31 (31%) set no upper age limit and 68 (67%) stop at 75 or younger; 46 take children under 18; 21 take healthy volunteers.
This study: 15 Years to 40 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
28 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 5 started in 2025.
This study's planned enrollment of 80 is above the median of 71 across 452 interventional studies indexed under Feeding and Eating Disorders.
Median enrollment 74 across the 18 interventional studies, 109 across the 10 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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None of the 28 has an industry lead sponsor. The 10 most frequent:
Istituto per la Ricerca e l'Innovazione Biomedica is the lead sponsor of 47 studies on the registry; 29 are open to participants now.
Istituto per la Ricerca e l'Innovazione Biomedica has 1 study filed under Feeding and Eating Disorders — fewer than ten, so there is no comparison to draw.
3 of the studies in Feeding and Eating Disorders with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06870006Meyer Children's Hospital IRCCSPsychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population | 2027-01 |
| NCT07106645University of PadovaIntermittent Theta Burst Transcranial Magnetic Stimulation of the Right Parietal Lobe in Anorexia Nervosa | 2027-01-15 |
| NCT07295470Istituto Auxologico ItalianoSleep and Activity For Eating Disorders | 2027-05 |
Add all 3 to your calendar (.ics) → With an account.
Among the 28 studies in Feeding and Eating Disorders with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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)
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)
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.
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.
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.
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.
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).
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)
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)
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)
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.
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)
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."
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)
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.
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)
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.
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)
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).
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)
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.
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)
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.
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)
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.
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).
Plan to share: No
Started Jan 2025 (actual). Primary completion is estimated for Jul 2025, 6 months after the start.
Of 269 non-industry interventional studies with no phase under Feeding and Eating Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's planned 6 months is below that.
Counting every sponsor, half of 274 studies reached it within 28 months; a quarter within 14 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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Istituto per la Ricerca e l'Innovazione Biomedica