Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-06-21 @ 5:36 PM
Study NCT ID:
NCT03499392
Status:
UNKNOWN
Last Update Posted:
2018-04-17
First Post:
2018-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}], 'ancestors': [{'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D007406', 'term': 'Interview, Psychological'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-04-09', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of headache attacks', 'timeFrame': 'Month 9', 'description': 'Symptomatic evolution assessed with a composite outcome (number of episodes + severity of headaches) reported by patient and collected during neurological consultation'}, {'measure': 'Duration of each headache attack', 'timeFrame': 'Month 9', 'description': 'Symptomatic evolution assessed with a composite outcome (number of episodes + duration of each episode) reported by patient and collected during neurological consultation'}], 'secondaryOutcomes': [{'measure': "Definition of patient's psychological profile", 'timeFrame': 'Month 9', 'description': 'Profile is determined by additional semi-structured interviews + Rorschach test + Adult Attachment Interview + mini-Social cognition and Emotional Assesment test (qualitative outcomes).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychological factors'], 'conditions': ['Primary Headache Disorder']}, 'descriptionModule': {'briefSummary': 'The World Health Organization (WHO) ranks headache among the top 20 causes of disability in the world.\n\nPrimary headaches (with no known organic cause) account for 90% of these conditions. INSERM estimates that 15% of the general population is concerned. WHO estimates that 1.7-4% of the global adult population is affected by headache for at least 15 days a month. Headaches are disabling, for patients (pain, suffering, fatigue, unavailability ...) but also for society (socio-economic cost as frequent work stoppages and drug costs). They are a public health problem.\n\nIn 2002, the High Authority of Health published its recommendations for the diagnosis and management of migraine patients. In addition, the French Society for Migraine and Headache Studies updated these recommendations in 2013. They are focused on the medical management offered by doctors and pharmacists. However, the professionals in daily contact with the subjects know that the dimension psychic plays an important role in the etiology of headaches.', 'detailedDescription': 'The review of the literature shows the keen interest and the need for this type of research to better understand the main psychological factors involved in primary headaches.\n\nThe current vagueness, the lack of knowledge regarding the aspects associated psychological and the lack of studies on the French population can be filled with this study which takes place at the University Hospital of Besançon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first consultation in neurology good general somatic state\n\nExclusion Criteria:\n\n* Pregnancy History of psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT03499392', 'acronym': 'CEPRIVA', 'briefTitle': 'Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.', 'orgStudyIdInfo': {'id': 'P/2017/344'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'psychological investigation', 'interventionNames': ['Other: psychological tests']}], 'interventions': [{'name': 'psychological tests', 'type': 'OTHER', 'otherNames': ['psychological interviews'], 'description': 'psychological tests psychological interviews', 'armGroupLabels': ['psychological investigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'state': 'Doubs', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'rose-angelique Belot', 'role': 'CONTACT', 'email': 'rose-angelique.belot@univ-fcomte.fr', 'phone': '0680188113'}, {'name': 'Margaux Bouteloup', 'role': 'CONTACT', 'email': 'margaux.bouteloup@live.fr', 'phone': '0636924397'}], 'facility': 'Belot', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Rose-Angélique BELOT', 'role': 'CONTACT', 'email': 'rose-angelique.belot@univ-fcomte.fr', 'phone': '0680188113'}, {'name': 'Margaux BOUTELOUP', 'role': 'CONTACT', 'email': 'margaux.bouteloup@live.fr', 'phone': '0636924397'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}