Actively Recruiting

Phase Not Applicable
Age: 15Years - 40Years
All Genders
Healthy Volunteers
ID06799962

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

Led by Istituto per la Ricerca e l'Innovazione Biomedica · Updated on 2025-04-30

80

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

I

Istituto per la Ricerca e l'Innovazione Biomedica

Lead Sponsor

M

Madre Teresa s.r.l

Collaborating Sponsor

AI-Summary

What this Trial Is About

Eating disorders, including Anorexia Nervosa and Bulimia Nervosa, affect how individuals relate to food and body image. Researchers are studying new treatments using virtual reality (VR) combined with artificial intelligence (AI) to provide personalized therapy systems. These advanced approaches aim to improve diagnosis and treatment effectiveness by monitoring severity, risks, and responses to therapy more accurately than traditional cognitive behavioral therapy (CBT). The study includes four groups: two intervention groups using VR and AI technologies tailored for Anorexia Nervosa (Enhanced Body-Swap) and Bulimia Nervosa (Emotional Rescripting), and two control groups receiving standard CBT without VR or AI. The Anorexia treatment involves 12 bi-weekly VR sessions where participants embody virtual avatars with gradually adjusted body mass index. The Bulimia treatment includes assessment, evaluation with biosensors, and 9 VR sessions focused on emotional regulation. Control groups follow similar therapy schedules without VR or AI. Participants undergo baseline assessments and follow-up evaluations at 4, 8, and 12 weeks using various scales measuring eating disorder symptoms, body image, anxiety, emotional regulation, and food craving. The study uses questionnaires and biosensors to monitor progress and therapy effects. Total participation includes treatment sessions and multiple follow-up assessments to evaluate the long-term impact of the interventions.

CONDITIONS

Brief Title

AI and VR Devices for Eating Behavior Rehabilitation

Who Can Participate

Age: 15Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR and ICD-11 confirmed by a public hospital
  • Body Mass Index (BMI) between 16 and 32
  • Disorder present for at least 6 months
  • No other concurrent psychotherapeutic interventions during the study
  • Previous diagnosis confirmed by assessment and consent from expert professionals
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

Duration - 1 session

Participants complete baseline assessments including anamnesis and therapeutic efficacy data collection before starting treatment.

1 visit (in-person)

Evaluation Phase

Duration - 2 sessions

Participants complete evaluation sessions involving craving assessments and physiological data collection (for Bulimia Nervosa groups) or baseline data collection without VR (for control groups).

2 visits (in-person)

Treatment

Duration - 12 bi-weekly sessions for Anorexia Nervosa or 9 sessions for Bulimia Nervosa

Participants undergo active treatment sessions. For Anorexia Nervosa, 12 bi-weekly sessions involve VR-enhanced virtual avatar embodiment or standard cognitive-behavioral therapy. For Bulimia Nervosa, 9 sessions focus on emotional regulation and craving management using VR or traditional cognitive-behavioral therapy.

12 sessions bi-weekly or 9 sessions depending on group assignment

Follow-up

Duration - 12 weeks

Participants attend follow-up visits at 4, 8, and 12 weeks after treatment to assess long-term progress and treatment effects.

3 visits (in-person) at 4, 8, and 12 weeks post-treatment

Trial Site Locations

Total: 1 location

1

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

Messina, Italy, Italy, 98164

Actively Recruiting

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Research Team

F

Flavia marino

M

Maria Valeria Maiorana

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Bringing Virtual Reality From Clinical Trials to Clinical Practice for the Treatment of Eating Disorders: An Example Using Virtual Reality Cue Exposure Therapy.

Theresa Brown, Emily Nauman Vogel, Sarah Adler...

https://pubmed.ncbi.nlm.nih.gov/32324145

Using Virtual Reality Exposure Therapy to Enhance Treatment of Anxiety Disorders: Identifying Areas of Clinical Adoption and Potential Obstacles.

Debra Boeldt, Elizabeth McMahon, Mimi McFaul...

https://pubmed.ncbi.nlm.nih.gov/31708821