Anorexia NervosaVIRECNCT05801016
Virtual Reality and Autobiographical Recall in Anorexia Nervosa: a Preliminary Study
A study testing Emerging Technologies and Training in Neurosciences in people with Anorexia Nervosa, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Clinical trial in patients with Anorexia Nervosa using body-swapping technique e Virtual Reality Body Size estimation tasks and Autobiographic Recall on sympton remission (EDI-3; EDE-Q), body satisfaction and perception Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Emerging Technologies and Training in Neurosciences
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jun 2019to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Anorexia Nervosa
- Body mass index equal or superior to 15 kg/m2
- Mother tongue Italian
- Semiresidential rehabilitation program
Who cannot join
- Other eating disorders
- Neurological disorders , clinical history of cerebral damage, presence of psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Milan, 20100
Luca Persani, MD PhD, 390261911 ext. 2738-2400, luca.persani@unimi.it
Giuseppe Riva, prof, 390261911, giuseppe.riva@unicatt.it
About this study
Official title: Esplorare l'Effetto di un Protocollo Combinato di Realtà Virtuale e Autobiographical Recall su Memoria, Percezione, Affetto in Pazienti Con Anoressia Nervosa: Uno Studio Preliminare
Clinical trial in patients with Anorexia Nervosa using body-swapping technique e Virtual Reality Body Size estimation tasks and Autobiographic Recall on sympton remission (EDI-3; EDE-Q), body satisfaction and perception
- Conditions
- Anorexia Nervosa
- Being tested
- Emerging Technologies and Training in Neurosciences
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emerging Technologies and Training in NeurosciencesBehavioural
Combination of body-swapping technique, Virtual Reality Body Size estimation tasks and Autobiographic Recall
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa | Other | Female anorexia nervosa patients Receives: Behavioral: Emerging Technologies and Training in Neurosciences |
| Healthy controls | Other | Healthy female control participants Receives: Behavioral: Emerging Technologies and Training in Neurosciences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimation of body weight
Overestimation of body weight measured through Eating Disorder Inventory (EDI-3)
Measured: At baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start28 Jun 2019
- Primary completion8 Mar 2023
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Riva, prof, Study director, università cattolica Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801016
- Sponsor's protocol ID
- 05C923
- Acronym
- VIREC
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esplorare l'Effetto di un Protocollo Combinato di Realtà Virtuale e Autobiographical Recall su Memoria, Percezione, Affetto in Pazienti Con Anoressia Nervosa: Uno Studio Preliminare
- ClinicalTrials.gov ID
- NCT05801016
- Acronym / sponsor ID
- VIREC / 05C923
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- Jan 2024 (estimated)
- First posted
- 6 Apr 2023 (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.
Clinical trial in patients with Anorexia Nervosa using body-swapping technique e Virtual Reality Body Size estimation tasks and Autobiographic Recall on sympton remission (EDI-3; EDE-Q), body satisfaction and perception
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa | Other | Behavioral: Emerging Technologies and Training in NeurosciencesFemale anorexia nervosa patients |
| Healthy controls | Other | Behavioral: Emerging Technologies and Training in NeurosciencesHealthy female control participants |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Anorexia Nervosa
- Body mass index equal or superior to 15 kg/m2
- Mother tongue Italian
- Semiresidential rehabilitation program
Key exclusion criteria (2 listed)
- Other eating disorders
- Neurological disorders , clinical history of cerebral damage, presence of psychiatric disorders
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 |
|---|---|---|
| Emerging Technologies and Training in NeurosciencesCombination of body-swapping technique, Virtual Reality Body Size estimation tasks and Autobiographic Recall | Behavioural | Anorexia nervosa, Healthy controls |
Primary outcome
Change in estimation of body weight
Time frame: At baseline and after 12 months
Overestimation of body weight measured through Eating Disorder Inventory (EDI-3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Giuseppe Riva, prof study director
università cattolica Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emerging Technologies and Training in Neurosciences in people with Anorexia Nervosa, run by Istituto Auxologico Italiano 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Persani, MD PhD (390261911; ext. -2400 or -2738, luca.persani@unimi.it;), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimation of body weight (time frame: At baseline and after 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2023.