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

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Recruiting

CT.gov ID

NCT05801016

Collaborator

(none)

Enrollment

Location

Arms

54.1

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Behavioral: Emerging Technologies and Training in Neurosciences	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jun 28, 2019

Actual Primary Completion Date :

Mar 8, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in estimation of body weight [At baseline and after 12 months]
Overestimation of body weight measured through Eating Disorder Inventory (EDI-3)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Auxologico Italiano	Milano		Italy	20100

Sponsors and Collaborators

Istituto Auxologico Italiano

Investigators

Study Director: Giuseppe Riva, prof, università cattolica Milano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Auxologico Italiano

ClinicalTrials.gov Identifier:

NCT05801016

Other Study ID Numbers:

05C923

First Posted:

Apr 6, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anorexia

Anorexia Nervosa

Study Results

No Results Posted as of Apr 6, 2023