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TerminatedNCT03118921REVAMUpdated Dec 28, 2021

Body Image Disorder in Anorexia Nervosa and Virtual Reality

An interventional study of Virtual reality in Anorexia, sponsored by University Hospital, Brest. Terminated at 1 site in France. Open to female participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-12-28.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Device feasibility

Why this study was terminated
suggestion of an accentuation of the bias of overestimating the silhouette in one of the avatar exposure modalities in virtual reality
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
16 Years to 40 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Anorexia
03

Who can participate

Ages eligible
16 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • 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

Interventions

  • DeviceVirtual 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.

05

What researchers measure

Primary outcomes

  1. Self-questionnaire assessing tolerance

    Patients will have to respond to a self-administered questionnaire assessing tolerance

    Time frame: Day 15

  2. Self-questionnaire assessing acceptability

    Patients will have to respond to a self-administered questionnaire assessing acceptability

    Time frame: Day 15

Secondary outcomes

  1. Feeling of presence

    Patients will respond to a self-questionnaire of feeling of presence

    Time frame: Day 15

  2. Subjective experience by EDI-2 questionnaire

    Pre- and post-test comparison of body dissatisfaction by EDI-2 questionnaire.

    Time frame: Day 15

  3. Subjective experience by BSQ questionnaire

    Pre- and post-test comparison of body dissatisfaction by BSQ questionnaire.

    Time frame: Day 15

06

Study locations

1 site
  • CHRU Brest
    Brest, 29200, France
07

Registry details

Key details

Study ID
NCT03118921
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Apr 18, 2017
Start date
Apr 20, 2017
Primary completion
Oct 31, 2019
Completion
Oct 31, 2019
Last update
Dec 28, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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