Back to resultsPerception and Representation of Internal Body in Anorexia Nervosa (PERCEPCOR)
Primary Purpose
Anorexia Nervosa
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
perceptive tests
Sponsored by
About this trial
This is an interventional other trial for Anorexia Nervosa focused on measuring Body awareness, Interoceptive awareness, Anorexia Nervosa, Adolescent, Body image
Eligibility Criteria
Inclusion Criteria:
- Anorexia Nervosa according to DSM-5
- aged above than 14
- BMI between 14 and 18.5 for adults or less than the reference age by age for minors
Exclusion Criteria:
- Unable to understand the tests, poor understanding of the French language
- Mental retardation
- Severe psychiatric comorbidity (bipolar disorder, schizophrenia)
- Lesion or pathology of the upper limbs
- Pregnancy
- Absence of social protection
- Hospitalization under duress
Sites / Locations
- Centre Hospitalier Esquirol
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anorexia
Control
Arm Description
Subjects with anorexia nervosa
Subjects without eating disorders
Outcomes
Primary Outcome Measures
drawing
Number and nature of organs drawn
Secondary Outcome Measures
IAI
interoceptive awareness index
Time
time to obtain a score of 3 on the analogue visual scale at the ischemia induction test
Full Information
NCT ID
NCT03988218
First Posted
June 13, 2019
Last Updated
July 19, 2021
Sponsor
Centre Hospitalier Esquirol
1. Study Identification
Unique Protocol Identification Number
NCT03988218
Brief Title
Perception and Representation of Internal Body in Anorexia Nervosa
Acronym
PERCEPCOR
Official Title
Perception and Representation of Internal Body in Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
July 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Esquirol
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
This study focuses on representations of the interior of the body and interoceptive awareness in women with anorexia nervosa in comparison with women without eating disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Body awareness, Interoceptive awareness, Anorexia Nervosa, Adolescent, Body image
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anorexia
Arm Type
Experimental
Arm Description
Subjects with anorexia nervosa
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects without eating disorders
Intervention Type
Behavioral
Intervention Name(s)
perceptive tests
Other Intervention Name(s)
scales
Intervention Description
many tests are realized: a drawing of the interior of the body a heartbeat detection test an ischemia induction test many scales: Eating Attitude Test; Body Awareness Questionnaire; Body Shape Questionnaire; Hospital Anxiety and Depression; Questionnaire de Satisfaction Corporelle et de Perception Globale de Soi
Primary Outcome Measure Information:
Title
drawing
Description
Number and nature of organs drawn
Time Frame
At inclusion
Secondary Outcome Measure Information:
Title
IAI
Description
interoceptive awareness index
Time Frame
At inclusion
Title
Time
Description
time to obtain a score of 3 on the analogue visual scale at the ischemia induction test
Time Frame
At inclusion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Anorexia Nervosa according to DSM-5
aged above than 14
BMI between 14 and 18.5 for adults or less than the reference age by age for minors
Exclusion Criteria:
Unable to understand the tests, poor understanding of the French language
Mental retardation
Severe psychiatric comorbidity (bipolar disorder, schizophrenia)
Lesion or pathology of the upper limbs
Pregnancy
Absence of social protection
Hospitalization under duress
Facility Information:
Facility Name
Centre Hospitalier Esquirol
City
Limoges
ZIP/Postal Code
87000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Perception and Representation of Internal Body in Anorexia Nervosa
We'll reach out to this number within 24 hrs