Clinical trial NCT06799962: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Madre Teresa s.r.l
name: Medilink s.r.l.
name: SB SETEC S.p.A
name: Catholic University of the Sacred Heart
First posted: 2025-01-29
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Eating Disorder Inventory-3 (EDI-3)
timeFrame: 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)
measure: Physical Appearance State and Trait Anxiety Scale (PASTAS)
timeFrame: 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.
measure: Body Image Assessment Scale-Body Dimensions (BIAS-BD)
timeFrame: 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.
measure: Body Appreciation Scale-2 (BAS-2)
timeFrame: 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.
measure: Objectified Body Consciousness Scale (OBCS)
timeFrame: 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.
measure: Body Uneasiness Test (BUT)
timeFrame: 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.
measure: Food Craving Questionnaire (FCQ)
timeFrame: 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).
measure: Binge Eating Scale (BES)
timeFrame: 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).
measure: Difficulties in Emotional Regulation Scale (DERS-20)
timeFrame: 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).
measure: State and Trait Anxiety Inventory (STAI)
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.