Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT03988218
Status:
COMPLETED
Last Update Posted:
2021-07-20
First Post:
2019-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perception and Representation of Internal Body in Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2019-06-13', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'drawing', 'timeFrame': 'At inclusion', 'description': 'Number and nature of organs drawn'}], 'secondaryOutcomes': [{'measure': 'IAI', 'timeFrame': 'At inclusion', 'description': 'interoceptive awareness index'}, {'measure': 'Time', 'timeFrame': 'At inclusion', 'description': 'time to obtain a score of 3 on the analogue visual scale at the ischemia induction test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body awareness', 'Interoceptive awareness', 'Anorexia Nervosa', 'Adolescent', 'Body image'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '38979073', 'type': 'DERIVED', 'citation': 'Paquet A, Girard M, Passerieux C, Boule MC, Lacroix A, Sazerat P, Olliac B, Nubukpo P. The body interior in anorexia nervosa: from interoception to conceptual representation of body interior. Front Psychol. 2024 Jun 24;15:1389463. doi: 10.3389/fpsyg.2024.1389463. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anorexia Nervosa according to DSM-5\n* aged above than 14\n* BMI between 14 and 18.5 for adults or less than the reference age by age for minors\n\nExclusion Criteria:\n\n* Unable to understand the tests, poor understanding of the French language\n* Mental retardation\n* Severe psychiatric comorbidity (bipolar disorder, schizophrenia)\n* Lesion or pathology of the upper limbs\n* Pregnancy\n* Absence of social protection\n* Hospitalization under duress'}, 'identificationModule': {'nctId': 'NCT03988218', 'acronym': 'PERCEPCOR', 'briefTitle': 'Perception and Representation of Internal Body in Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Esquirol'}, 'officialTitle': 'Perception and Representation of Internal Body in Anorexia Nervosa', 'orgStudyIdInfo': {'id': 'percepcor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anorexia', 'description': 'Subjects with anorexia nervosa', 'interventionNames': ['Behavioral: perceptive tests']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Subjects without eating disorders', 'interventionNames': ['Behavioral: perceptive tests']}], 'interventions': [{'name': 'perceptive tests', 'type': 'BEHAVIORAL', 'otherNames': ['scales'], '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', 'armGroupLabels': ['Anorexia', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87000', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospitalier Esquirol', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Esquirol', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Aude Paquet', 'investigatorAffiliation': 'Centre Hospitalier Esquirol'}}}}