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

Primary Purpose

Anorexia Nervosa

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Emerging Technologies and Training in Neurosciences

About this trial

This is an interventional supportive care trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Istituto Auxologico ItalianoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Anorexia nervosa

Healthy controls

Arm Description

Female anorexia nervosa patients

Healthy female control participants

Outcomes

Primary Outcome Measures

Change in estimation of body weight

Overestimation of body weight measured through Eating Disorder Inventory (EDI-3)

Secondary Outcome Measures

Full Information

NCT ID

NCT05801016

First Posted

March 8, 2023

Last Updated

March 23, 2023

Sponsor

Istituto Auxologico Italiano

1. Study Identification

Unique Protocol Identification Number

NCT05801016

Brief Title

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

Acronym

VIREC

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 28, 2019 (Actual)

Primary Completion Date

March 8, 2023 (Actual)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia Nervosa

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anorexia nervosa

Arm Type

Other

Arm Description

Female anorexia nervosa patients

Arm Title

Healthy controls

Arm Type

Other

Arm Description

Healthy female control participants

Intervention Type

Behavioral

Intervention Name(s)

Emerging Technologies and Training in Neurosciences

Intervention Description

Combination of body-swapping technique, Virtual Reality Body Size estimation tasks and Autobiographic Recall

Primary Outcome Measure Information:

Title

Change in estimation of body weight

Description

Overestimation of body weight measured through Eating Disorder Inventory (EDI-3)

Time Frame

At baseline and after 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luca Persani, MD PhD

Phone

390261911;

Ext

-2400 or -2738

luca.persani@unimi.it;

First Name & Middle Initial & Last Name or Official Title & Degree

Nicoletta Polli, MD

Phone

390261911

Ext

2882

n.polli@auxologico.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Riva, prof

Organizational Affiliation

università cattolica Milano

Official's Role

Study Director

Facility Information:

Facility Name

Istituto Auxologico Italiano

City

Milano

ZIP/Postal Code

20100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luca Persani, MD PhD

Phone

390261911

Ext

2738-2400

luca.persani@unimi.it

First Name & Middle Initial & Last Name & Degree

Giuseppe Riva, prof

Phone

390261911

giuseppe.riva@unicatt.it

First Name & Middle Initial & Last Name & Degree

Nicoletta Polli, MD

First Name & Middle Initial & Last Name & Degree

Chiara Cacciatore, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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