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Perception and Representation of Internal Body in Anorexia Nervosa (PERCEPCOR)

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ClinicalTrials.gov Identifier: NCT03988218
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Aude Paquet, Centre Hospitalier Esquirol

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: perceptive tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Perception and Representation of Internal Body in Anorexia Nervosa
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : July 11, 2021
Estimated Study Completion Date : July 11, 2021

Arm Intervention/treatment
Experimental: Anorexia
Subjects with anorexia nervosa
Behavioral: perceptive tests
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
Other Name: scales

Active Comparator: Control
Subjects without eating disorders
Behavioral: perceptive tests
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
Other Name: scales




Primary Outcome Measures :
  1. drawing [ Time Frame: At inclusion ]
    Number and nature of organs drawn


Secondary Outcome Measures :
  1. IAI [ Time Frame: At inclusion ]
    interoceptive awareness index

  2. Time [ Time Frame: At inclusion ]
    time to obtain a score of 3 on the analogue visual scale at the ischemia induction test



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT03988218


Contacts
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Contact: Aude PAQUET, PhD +33555431127 aude.paquet@ch-esquirol-limoges.fr

Locations
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France
Centre Hospitalier Esquirol Recruiting
Limoges, France, 87000
Contact: Aude PAQUET, PhD    +33555431127    aude.paquet@ch-esquirol-limoges.fr   
Contact: Aude PAQUET, PhD       aude.paquet@ch-esquirol-limoges.fr   
Principal Investigator: Aude PAQUET, PhD         
Sponsors and Collaborators
Centre Hospitalier Esquirol

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Responsible Party: Aude Paquet, PhD, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier: NCT03988218     History of Changes
Other Study ID Numbers: percepcor
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aude Paquet, Centre Hospitalier Esquirol:
Body awareness
Interoceptive awareness
Anorexia Nervosa
Adolescent
Body image
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders