An interventional study of Virtual reality food exposure and Virtual Reality Nature Exposure in Anorexia Nervosa, sponsored by University of Padova. Recruiting at 1 site in Italy. Open to female participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by University of Padova · Not applicable, Interventional, and Treatment
Among 30 studies in Anorexia Nervosa with a site in Italy — 10 open to participants now, 11 under way, none of them phase 3. Anorexia Nervosa · Italy.
Among the 30 studies in Anorexia Nervosa with a site in Italy, this one is the 8th largest by planned enrollment of the 12 interventional ones that give a count, is one of 11 that started in 2024, is one of 12 with no phase, reaches primary completion later than 2 of the 10 other live ones, and was the 18th registered.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
Browse Anorexia Nervosa studies →10 of the 30 studies in Anorexia Nervosa with a site in Italy are open now. Recruiting first, the newest first:
Istituto per la Ricerca e l'Innovazione Biomedica · Sites in Italy
Ages 15–40 · Healthy volunteers
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 14–65 · Healthy volunteers
Meyer Children's Hospital IRCCS · Sites in Italy
Ages 12–40 · Women only
Istituto Auxologico Italiano · Sites in Italy
Ages 16–65
Istituto Auxologico Italiano · Sites in Italy
Ages 18–80
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 83 Anorexia Nervosa studies recruiting now, 18 (22%) set no upper age limit and 61 (73%) stop at 75 or younger; 48 take children under 18; 26 take healthy volunteers.
This study: 14 Years and older · female · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 11 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Median enrollment 74 across the 12 interventional studies, 60 across the 18 observational. Of the 16 that completed or were terminated, 0 (0%) have results posted.
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None of the 30 has an industry lead sponsor. The 10 most frequent:
University of Padova is the lead sponsor of 215 studies on the registry; 42 are open to participants now.
University of Padova has 2 studies filed under Anorexia Nervosa — fewer than ten, so there is no comparison to draw.
2 of the studies in Anorexia Nervosa 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 |
|---|---|
| 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 2 to your calendar (.ics) → With an account.
Among the 30 studies in Anorexia Nervosa with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Exposure to food stimuli often elicit aversive emotions in patients with anorexia nervosa, which can perpetuate eating-related avoidance. Exposure therapy has been shown to effectively reduce anxiety toward, and avoidance of, feared stimuli in several psychiatric disorders. Digital technologies, such as virtual reality (VR) have been employed to implement exposure therapy in situations where in vivo exposure is unfeasible, challenging, or perceived as threatening by patients. VR has also the potential to be used by individuals repeatedly in their own time and environment, to consolidate new learning. This pilot randomised controlled study evaluates the feasibility and clinical impact of repeated VR exposure to food stimuli in patients with anorexia nervosa attending intensive daycare treatment (treatment as usual, TAU). VR food exposure will be compared to the use of a relaxation-focused VR scenario (natural environment) and a control condition (no use of VR). Patients in all groups will receive TAU.
Patients with anorexia nervosa are recruited from daycare services at Eating Disorder Units in Italy. Inclusion criteria are: (1) current diagnosis of anorexia nervosa according to DSM-5 criteria; (2) 14 years or older. Exclusion criteria are: (1) diagnosis of neurological disorders, (2) diagnosis of psychosis or substance abuse disorders, (3) visual/hearing impairments not corrected by glasses/ear implants; (4) non-tolerance of exposure to VR (i.e., cybersickness, dizziness).
Each patient is randomly assigned to one of three conditions: repeated food exposure in a VR kitchen environment + TAU, repeated exposure to a VR natural setting + TAU, or TAU alone .
VR Food Exposure: Patients in this condition undergo one session of VR exposure in a kitchen environment each day for 5 consecutive days (from Monday, day 1, to Friday, day 5). Each session lasts 5 minutes. The VR environment has been specifically developed by the study team and it was tested in a previous one-session study. The scenario consists of a kitchen with foods of different calorie contents either immediately visible in the environment (for example on a table) or stored in drawings, refrigerators, cabinets. Once in the kitchen, patients can freely move, open the cupboards and the fridge, and grab and hold the foods. Patients are invited to explore the environment and interact with the stimuli they feel most comfortable with. Based on their preference, in each session participants access one of three versions of the virtual kitchen: the virtual kitchen alone, a virtual kitchen + a pink elephant (designed to induce positive mood), or a virtual kitchen + a reassuring voice that encourages to interact with foods and face food-related fears.
VR Nature Exposure: Patients in this condition undergo one session of VR exposure to a natural scenario each day, for 5 consecutive days (from Monday to Friday), through the NatureTreks app. Each session lasts 5 minutes. Participants perform the exposure while seated, and are instructed to observe the environment and try to relax. Based on their preference, in each session participants are able to choose one of three different natural environments: a white sand beach ("Blue Ocean"), a snowy mountain ("White Winter"), or a forest in autumn foliage ("Red Fall")
TAU: It consists of a daycare program (attendance Monday to Friday) including individual psychological therapy (based on cognitive-behavioral principles), nutritional counseling, assisted meals, group activities (e.g., psychotherapy, art therapy, music therapy, relaxation protocols), and psychoeducation for family members. For ethical reasons, at the end of the follow-up assessment, participants in the control group are given the opportunity to engage in VR exposure.
Patients in all conditions complete a baseline (day 0) and end of intervention (day 5) assessment. The baseline assessment includes:
The PANAS, the STAI, the motivational ruler, food evaluation, and meal related anxiety are completed at the end of intervention.
Each day, immediately before and after the exposure, participants in the food and nature exposure groups are asked to rate, on a scale from 0 to 100, their anxiety in the moment and also the anxiety they feel when thinking of the next meal. At the end of each exposure session, they are asked to rate their sense of presence and discomfort in the VR environment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion 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.
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.
Five sessions of exposure to a virtual kitchen (one session/day, over a week). Participants in this arm will continue receiving treatment as usual for their eating disorder at the treatment center
Behavioral: Virtual reality food exposure
Five sessions of exposure to a virtual natural environment (one session/day, over a week). Participants in this arm will continue receiving treatment as usual for their eating disorder at the treatment center
Behavioral: Virtual Reality Nature Exposure
Patients in this condition will receive treatment as usual only
Patients in this condition are exposed to a virtual kitchen environment once/day, for 5 consecutive days (from Monday, day 1, to Friday, day 5). Each session lasts 5 minutes. The VR environment was specifically developed by the study team (Natali et al, 2024) and it consists of a kitchen with foods of different calorie contents. Patients are invited to explore the environment; they can freely move, open the cupboards and the fridge, and grab and hold the foods. Participants can choose to interact with one of three versions of the virtual kitchen environment: a) a kitchen alone, b) a kitchen with a virtual pet which participants can interact with (and aimed at inducing positive mood) and c) a kitchen with a compassionate avatar which motivates the participant to face food-related fears.
Patients in this condition complete a session of VR exposure to a natural scenario (from the NatureTreksVR app) for 5 consecutive days (from Monday to Friday), one session/day. Each session lasts 5 minutes. Participants can choose exposure to one of three different natural environments, at the start of each session: a white sand beach ("Blue Ocean"), a snowy mountain ("White Winter"), or a forest in autumn foliage ("Red Fall").
Change from baseline to end of intervention in meal related anxiety
Meal related anxiety is assessed on a Likert scale from 0 (no anxiety) to 10 (extreme anxiety)
Time frame: Measurements at baseline and day 5
Feasibility of exposure to the virtual reality environments
Percentage of participants who interrupt exposure to the virtual reality environment before completion. Discomfort associated to the virtual reality exposure session, rated at the end of each session on a visual analogue scale (0-100).
Time frame: Following each of five exposure sessions, over a time period of five days
Change from baseline to end of treatment in positive and negative affect
The PANAS is a validated self-report instrument consisting of two subscales assessing respectively positive and negative affect. The score of each subscale can range from 10 to 50, with higher scores representing higher levels of positive/negative affect.
Time frame: Measurements at baseline and day 5
Change from baseline to end of intervention in state anxiety
The STAI state is a 20-item self-report scale for the assessment of state anxiety. Possible scores range from 0 to 80 and greater scores indicate greater anxiety
Time frame: Measurements at baseline and day 5
Change from baseline to end of intervention in food pictures evaluation
Food-related wanting, liking and fear will be measured in response to the presention of 21 pictures of foods of different caloric content, using a scale from 0 (not at all) to 100 (extremely).
Time frame: Measurements at baseline and day 5
Effect sizes of changes in anxiety and meal related anxiety from before to after virtual reality exposure
Ratings of general and meal related anxiety will be collected at the beginning and at the end of each virtual reality exposure session through a visual analogue scale ranging from 0 to 100.
Time frame: Measurements before and after each exposure session, over five days
Plan to share: No — a plan will be established by the research team for data sharing following publication of the first manuscript
Started Mar 2024 (actual). Primary completion is estimated for Sep 2025, 18 months after the start.
Of 151 non-industry interventional studies with no phase under Anorexia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's planned 18 months is below that.
Counting every sponsor, half of 151 studies reached it within 43 months; a quarter within 24 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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