Body Image Disorder in Anorexia Nervosa and Virtual Reality (REVAM)

Evaluation of the tolerance and acceptability of the virtual representation of its body image.

Study Overview

• Status: Terminated
• Conditions: Anorexia
• Intervention / Treatment: Device: Virtual reality

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHRU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women, aged between 16 and 40
• Post-puberty
• Pure restrictive anorexia nervosa, diagnosis by the DSM-V
• BMI <17.5
• Patient attending an outpatient clinic at the Bohars Psychiatric Hospital in France
• Having signed the Informed Consent Form
• For minor patients, signing the form of informed consent of both parents

Exclusion Criteria:

• Associated eating disorder (bulimia, or the binge eating / purging form of anorexia nervosa),
• Psychiatric disorders (characterized depressed, anxiety disorder)
• Neurological Disorders
• Mental retardation
• Abuse or addiction to alcohol
• Abuse or dependence on psychoactive substances in the previous year.
• Patient with a protective justice measure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Virtual reality; The first session aims to present the virtual reality material that will be used. The second session will take place 2 weeks after the first session and will consist of the use of the immersion software	Device: Virtual reality; The first session aims to present the virtual reality material that will be used. The second session will take place 2 weeks after the first session and will consist of the use of the immersion software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-questionnaire assessing tolerance	Patients will have to respond to a self-administered questionnaire assessing tolerance	Day 15
Self-questionnaire assessing acceptability	Patients will have to respond to a self-administered questionnaire assessing acceptability	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeling of presence	Patients will respond to a self-questionnaire of feeling of presence	Day 15
Subjective experience by EDI-2 questionnaire	Pre- and post-test comparison of body dissatisfaction by EDI-2 questionnaire.	Day 15
Subjective experience by BSQ questionnaire	Pre- and post-test comparison of body dissatisfaction by BSQ questionnaire.	Day 15

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2017
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (ACTUAL): April 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Somatoform Disorders; Anorexia; Anorexia Nervosa; Body Dysmorphic Disorders
• Other Study ID Numbers: REVAM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No