Back to resultsBody Image Disorder in Anorexia Nervosa and Virtual Reality (REVAM)
Primary Purpose
Anorexia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional device feasibility trial for Anorexia
Eligibility Criteria
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
Sites / Locations
- CHRU Brest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual reality
Arm Description
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
Outcomes
Primary Outcome Measures
Self-questionnaire assessing tolerance
Patients will have to respond to a self-administered questionnaire assessing tolerance
Self-questionnaire assessing acceptability
Patients will have to respond to a self-administered questionnaire assessing acceptability
Secondary Outcome Measures
Feeling of presence
Patients will respond to a self-questionnaire of feeling of presence
Subjective experience by EDI-2 questionnaire
Pre- and post-test comparison of body dissatisfaction by EDI-2 questionnaire.
Subjective experience by BSQ questionnaire
Pre- and post-test comparison of body dissatisfaction by BSQ questionnaire.
Full Information
NCT ID
NCT03118921
First Posted
April 3, 2017
Last Updated
December 10, 2021
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT03118921
Brief Title
Body Image Disorder in Anorexia Nervosa and Virtual Reality
Acronym
REVAM
Official Title
Body Image Disorder in Anorexia Nervosa and Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
suggestion of an accentuation of the bias of overestimating the silhouette in one of the avatar exposure modalities in virtual reality
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the tolerance and acceptability of the virtual representation of its body image.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-questionnaire assessing tolerance
Description
Patients will have to respond to a self-administered questionnaire assessing tolerance
Time Frame
Day 15
Title
Self-questionnaire assessing acceptability
Description
Patients will have to respond to a self-administered questionnaire assessing acceptability
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Feeling of presence
Description
Patients will respond to a self-questionnaire of feeling of presence
Time Frame
Day 15
Title
Subjective experience by EDI-2 questionnaire
Description
Pre- and post-test comparison of body dissatisfaction by EDI-2 questionnaire.
Time Frame
Day 15
Title
Subjective experience by BSQ questionnaire
Description
Pre- and post-test comparison of body dissatisfaction by BSQ questionnaire.
Time Frame
Day 15
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
12. IPD Sharing Statement
Learn more about this trial
Body Image Disorder in Anorexia Nervosa and Virtual Reality
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