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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118921
Recruitment Status : Unknown
Verified July 2017 by University Hospital, Brest.
Recruitment status was:  Recruiting
First Posted : April 18, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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Brief Summary:
Evaluation of the tolerance and acceptability of the virtual representation of its body image.

Condition or disease Intervention/treatment Phase
Anorexia Device: Virtual reality Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Body Image Disorder in Anorexia Nervosa and Virtual Reality
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : April 20, 2018
Estimated Study Completion Date : May 3, 2018
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Self-questionnaire assessing tolerance [ Time Frame: Day 15 ]
    Patients will have to respond to a self-administered questionnaire assessing tolerance

  2. Self-questionnaire assessing acceptability [ Time Frame: Day 15 ]
    Patients will have to respond to a self-administered questionnaire assessing acceptability


Secondary Outcome Measures :
  1. Feeling of presence [ Time Frame: Day 15 ]
    Patients will respond to a self-questionnaire of feeling of presence

  2. Subjective experience by EDI-2 questionnaire [ Time Frame: Day 15 ]
    Pre- and post-test comparison of body dissatisfaction by EDI-2 questionnaire.

  3. Subjective experience by BSQ questionnaire [ Time Frame: Day 15 ]
    Pre- and post-test comparison of body dissatisfaction by BSQ questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118921


Contacts
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Contact: Sofian Berrouiguet, Doctor sofian.berrouiguet@chu-brest.fr

Locations
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France
CHRU Brest Recruiting
Brest, France, 29200
Contact: Sofian Berrouiguet       sofian.berrouiguet@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
More Information
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03118921    
Other Study ID Numbers: REVAM
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Body Dysmorphic Disorders
Signs and Symptoms, Digestive
 Feeding and Eating Disorders
Mental Disorders
Somatoform Disorders