Study Results
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Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-01-30
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention Group for Anorexia Nervosa
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.
Enhanced Body-Swap for Anorexia Nervosa
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.
Intervention Group for Bulimia 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.
Emotional Rescripting for Bulimia Nervosa
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.
Control Group for Anorexia 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.
Standard Therapy for Anorexia Nervosa (Control)
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.
Control Group for Bulimia Nervosa
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.
Standard Therapy for Bulimia Nervosa (Control)
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.
Interventions
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Enhanced Body-Swap for Anorexia Nervosa
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
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)
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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
15 Years
40 Years
ALL
Yes
Sponsors
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Madre Teresa s.r.l
UNKNOWN
Medilink s.r.l.
UNKNOWN
SB SETEC S.p.A
UNKNOWN
Catholic University of the Sacred Heart
OTHER
Istituto per la Ricerca e l'Innovazione Biomedica
OTHER
Responsible Party
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Flavia Marino
Head of Unit
Principal Investigators
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Flavia Marino
Role: PRINCIPAL_INVESTIGATOR
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Locations
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Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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CNR-IRIB-PRO-2025-001
Identifier Type: -
Identifier Source: org_study_id
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