Study Stopped
suggestion of an accentuation of the bias of overestimating the silhouette in one of the avatar exposure modalities in virtual reality
Body Image Disorder in Anorexia Nervosa and Virtual Reality
REVAM
1 other identifier
interventional
17
1 country
1
Brief Summary
Evaluation of the tolerance and acceptability of the virtual representation of its body image.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedDecember 28, 2021
December 1, 2021
2.5 years
April 3, 2017
December 10, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Feeling of presence
Day 15
Subjective experience by EDI-2 questionnaire
Day 15
Subjective experience by BSQ questionnaire
Day 15
Study Arms (1)
Virtual reality
EXPERIMENTALThe 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU Brest
Brest, 29200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 18, 2017
Study Start
April 20, 2017
Primary Completion
October 31, 2019
Study Completion
October 31, 2019
Last Updated
December 28, 2021
Record last verified: 2021-12