Virtual Reality and Autobiographical Recall in Anorexia Nervosa: a Preliminary Study (VIREC)

March 23, 2023 updated by: Istituto Auxologico Italiano

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milano, Italy, 20100
        • Recruiting
        • Istituto Auxologico Italiano
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicoletta Polli, MD
        • Sub-Investigator:
          • Chiara Cacciatore, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Anorexia Nervosa
  • Body mass index equal or superior to 15 kg/m2
  • Mother tongue Italian
  • Semiresidential rehabilitation program

Exclusion Criteria:

  • Other eating disorders
  • Neurological disorders , clinical history of cerebral damage, presence of psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Anorexia nervosa
Female anorexia nervosa patients
Behavioral: Emerging Technologies and Training in Neurosciences
Combination of body-swapping technique, Virtual Reality Body Size estimation tasks and Autobiographic Recall
Other: Healthy controls
Healthy female control participants
Behavioral: Emerging Technologies and Training in Neurosciences
Combination of body-swapping technique, Virtual Reality Body Size estimation tasks and Autobiographic Recall

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At baseline and after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Investigators

  • Study Director: Giuseppe Riva, prof, università cattolica Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2019

Primary Completion (Actual)

March 8, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05C923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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