Anorexia NervosaNCT06795555
Virtual Reality Exposure to Reduce Food Related Anxiety in Anorexia Nervosa
A study testing Virtual reality food exposure and Virtual Reality Nature Exposure in people with Anorexia Nervosa, run by University of Padova at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Virtual reality food exposure and Virtual Reality Nature Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- current diagnosis of anorexia nervosa according to DSM-5 criteria
- 14 years or older.
Who cannot join
- diagnosis of neurological disorders
- diagnosis of psychosis or substance abuse disorders
- visual/hearing impairments not corrected by glasses/ear implants
- non-tolerance of exposure to VR (i.e., cybersickness, dizziness)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Padova
Padova, Italy, 35121
Valentina Cardi, PhD, +39 3713759534, valentina.cardi@unipd.it
Valentina Cardi, PhD
About this study
Official title: Virtual Food for Real Thought: a Pilot Randomised Controlled Trial of Virtual Reality Exposure in Anorexia Nervosa
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.
Read the detailed description
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:
- Demographic questionnaire (age, years of education, current pharmacological treatments, height, weight)
- Eating Disorder Examination Questionnaire
- Depression, Anxiety and Stress Scale
- Difficulties in Emotion Regulation Scale
- Positive and Negative Affect Schedule
- State and Trait Anxiety Scale
- Motivational Ruler: patients are asked to rate, on a scale from 0 to 10 importance and ability to change.
- Food evaluation: patients are asked to rate, on a scale from 0 to 100 wanting, liking and fear of 21 foods of different caloric content.
- Meal related anxiety: just before starting their meal at the hospital, patients are asked to rate their current level of anxiety on a scale from 0 to 10.
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.
- Conditions
- Anorexia Nervosa
- Being tested
- Virtual reality food exposure, Virtual Reality Nature Exposure
- Keywords
- mental health, eating disorders, exposure therapy, virtual reality
- Medical subject headings
- Anorexia Nervosa, Psychological Well-Being, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality food exposureBehavioural
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.
Virtual Reality Nature ExposureBehavioural
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").
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Food Exposure | Experimental | 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 Receives: Behavioral: Virtual reality food exposure |
| Virtual Reality Nature Exposure | Active comparator | 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 Receives: Behavioral: Virtual Reality Nature Exposure |
| Treatment as usual | No intervention | Patients in this condition will receive treatment as usual only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: Following each of five exposure sessions, over a time period of five days
Secondary outcomes (4)
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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: Measurements before and after each exposure session, over five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Mar 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly assigned to one of three conditions: (1) treatment as usual + virtual food exposure; (2) treatment as usual + virtual nature exposure; (3) treatment as usual
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salerno, Italy, Ospedale S.Bortolo -Vicenza, Italy
- Responsible party
- Principal investigator, CARDI VALENTINA, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795555
- Sponsor's protocol ID
- 6048/AO/24
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: a plan will be established by the research team for data sharing following publication of the first manuscript
Publications
Gratz, K.L., Roemer, L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment 26, 41-54 (2004). https://doi.org/10.1023/B:JOBA.0000007455.08539.94
Terracciano A, McCrae RR, Costa PT Jr. Factorial and construct validity of the Italian Positive and Negative Affect Schedule (PANAS). Eur J Psychol Assess. 2003;19(2):131-141. doi: 10.1027//1015-5759.19.2.131.
PubMed 20467578Bottesi G, Ghisi M, Altoe G, Conforti E, Melli G, Sica C. The Italian version of the Depression Anxiety Stress Scales-21: Factor structure and psychometric properties on community and clinical samples. Compr Psychiatry. 2015 Jul;60:170-81. doi: 10.1016/j.comppsych.2015.04.005. Epub 2015 Apr 15.
PubMed 25933937Calugi S, Milanese C, Sartirana M, El Ghoch M, Sartori F, Geccherle E, Coppini A, Franchini C, Dalle Grave R. The Eating Disorder Examination Questionnaire: reliability and validity of the Italian version. Eat Weight Disord. 2017 Sep;22(3):509-514. doi: 10.1007/s40519-016-0276-6. Epub 2016 Apr 2.
PubMed 27039107
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Food for Real Thought: a Pilot Randomised Controlled Trial of Virtual Reality Exposure in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT06795555
- Acronym / sponsor ID
- 6048/AO/24
- Conditions
- Anorexia Nervosa
- Keywords
- mental health, eating disorders, exposure therapy, virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- University of Salerno, Italy, Ospedale S.Bortolo -Vicenza, Italy
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Demographic questionnaire (age, years of education, current pharmacological treatments, height, weight)
- Eating Disorder Examination Questionnaire
- Depression, Anxiety and Stress Scale
- Difficulties in Emotion Regulation Scale
- Positive and Negative Affect Schedule
- State and Trait Anxiety Scale
- Motivational Ruler: patients are asked to rate, on a scale from 0 to 10 importance and ability to change.
- Food evaluation: patients are asked to rate, on a scale from 0 to 100 wanting, liking and fear of 21 foods of different caloric content.
- Meal related anxiety: just before starting their meal at the hospital, patients are asked to rate their current level of anxiety on a scale from 0 to 10.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patients are randomly assigned to one of three conditions: (1) treatment as usual + virtual food exposure; (2) treatment as usual + virtual nature exposure; (3) treatment as usual
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Food Exposure | Experimental | Behavioral: Virtual reality food exposureFive 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 |
| Virtual Reality Nature Exposure | Active comparator | Behavioral: Virtual Reality Nature ExposureFive 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 |
| Treatment as usual | No intervention | –Patients in this condition will receive treatment as usual only |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- current diagnosis of anorexia nervosa according to DSM-5 criteria
- 14 years or older.
Key exclusion criteria (4 listed)
- diagnosis of neurological disorders
- diagnosis of psychosis or substance abuse disorders
- visual/hearing impairments not corrected by glasses/ear implants
- non-tolerance of exposure to VR (i.e., cybersickness, dizziness)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality food exposurePatients 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. | Behavioural | Virtual Reality Food Exposure |
| Virtual Reality Nature ExposurePatients 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"). | Behavioural | Virtual Reality Nature Exposure |
Primary outcome
Change from baseline to end of intervention in meal related anxiety
Time frame: Measurements at baseline and day 5
Meal related anxiety is assessed on a Likert scale from 0 (no anxiety) to 10 (extreme anxiety)
Feasibility of exposure to the virtual reality environments
Time frame: Following each of five exposure sessions, over a time period of five days
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).
4 secondary outcomes
Change from baseline to end of treatment in positive and negative affect
Time frame: Measurements at baseline and day 5
Change from baseline to end of intervention in state anxiety
Time frame: Measurements at baseline and day 5
Change from baseline to end of intervention in food pictures evaluation
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
Time frame: Measurements before and after each exposure session, over five days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- BackgroundGratz, K.L., Roemer, L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment 26, 41-54 (2004). https://doi.org/10.1023/B:JOBA.0000007455.08539.94
- Background: PubMed 20467578Terracciano A, McCrae RR, Costa PT Jr. Factorial and construct validity of the Italian Positive and Negative Affect Schedule (PANAS). Eur J Psychol Assess. 2003;19(2):131-141. doi: 10.1027//1015-5759.19.2.131.
- Background: PubMed 25933937Bottesi G, Ghisi M, Altoe G, Conforti E, Melli G, Sica C. The Italian version of the Depression Anxiety Stress Scales-21: Factor structure and psychometric properties on community and clinical samples. Compr Psychiatry. 2015 Jul;60:170-81. doi: 10.1016/j.comppsych.2015.04.005. Epub 2015 Apr 15.
- Background: PubMed 27039107Calugi S, Milanese C, Sartirana M, El Ghoch M, Sartori F, Geccherle E, Coppini A, Franchini C, Dalle Grave R. The Eating Disorder Examination Questionnaire: reliability and validity of the Italian version. Eat Weight Disord. 2017 Sep;22(3):509-514. doi: 10.1007/s40519-016-0276-6. Epub 2016 Apr 2.
- Individual participant dataSharing planned: No. a plan will be established by the research team for data sharing following publication of the first manuscript
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality food exposure and Virtual Reality Nature Exposure in people with Anorexia Nervosa, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Cardi, PhD (+39 3713759534, valentina.cardi@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to end of intervention in meal related anxiety (time frame: Measurements at baseline and day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06795555, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.