Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-25 @ 2:07 AM
Study NCT ID:
NCT03623932
Status:
UNKNOWN
Last Update Posted:
2020-03-23
First Post:
2018-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014409', 'term': 'Tumor Necrosis Factor-alpha'}, {'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D015846', 'term': 'Monokines'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D048069', 'term': 'Tumor Necrosis Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective study, monocentric, controlled, randomized, open-label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-11-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-19', 'studyFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mid term hypnosis efficacy with IBDQ', 'timeFrame': '6 months', 'description': 'Efficacy evaluation of hypnosis 6 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)'}], 'secondaryOutcomes': [{'measure': 'Short term hypnosis efficacy with IBDQ', 'timeFrame': '3 months', 'description': 'Efficacy evaluation of hypnosis 3 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)'}, {'measure': 'Disease acceptance with ICQ-18', 'timeFrame': '3 months and 6 months', 'description': 'Impact of hypnosis on the disease acceptance short and mid term with the Evolution of the Illness Cognition Questionnaire for chronic disease'}, {'measure': 'Clinical score with Harvey-Bradshaw Index short and mid term', 'timeFrame': '3 months and 6 months', 'description': 'Evolution of the clinical score short and mid term with Harvey-Bradshaw Index'}, {'measure': 'Vagal tonus with electrocardiogram', 'timeFrame': '3 months and 6 months', 'description': 'Evolution of the vagal tonus with electrocardiogram short and mid term'}, {'measure': 'Inflammatory status with C Reactive Protein', 'timeFrame': '3 months and 6 months', 'description': 'Evolution of the C Reactive Protein concentration in the plasma'}, {'measure': 'Stress with Perceived Stress Scale', 'timeFrame': '3 months and 6 months', 'description': 'Evolution of stress status short and mid term with Perceived Stress Scale which goes from 10 to 50. Lower values represent better outcome.'}, {'measure': 'Fatigue with Multidimensional Fatigue Inventory', 'timeFrame': '3 months and 6 months', 'description': 'Evolution of fatigue status short and mid term'}, {'measure': 'Long term hypnosis efficacy', 'timeFrame': '12 months', 'description': 'Efficacy evaluation of hypnosis 12 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ) which goes from 32 to 224. Higher values represent better outcome.'}, {'measure': 'Clinical score with Harvey-Bradshaw Index long term', 'timeFrame': '12 months', 'description': 'Evolution of the clinical score long term with Harvey-Bradshaw Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '40243391', 'type': 'DERIVED', 'citation': 'Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life;', 'detailedDescription': 'Crohn disease is defined as an inflammatory chronic disease of the bowel characterize by intermittent flare-ups and remission periods.\n\nCrohn disease is due to genetic and environmental factors such as stress. Stress is an important aggravation factor of the disease symptoms which can stop a remission period and induce a relapse into a flare-up period.\n\nHypnosis is a non-medicinal technic which already show efficacy in the treatment of functional digestive troubles. These diseases are bio/psycho/social models such as Crohn disease.\n\nHypnosis can reduce visceral pain sensibility, reduce stress and reduce pro-inflammatory cytokines liberation into intestinal mucosa.\n\nThough, only few data are available on hypnosis interest in the treatment of Crohn disease and inflammatory bowel diseases as it is often isolated clinical case report.\n\nOne study on patients with rectocolitis in remission period has been done recently and show that hypnosis increased the duration of the remission period.\n\nThe principal objective of this study is to evaluate hypnosis efficacy in term of quality of life for patients with Crohn disease during remission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with ileal or colic Crohn disease\n* stable treatment for Crohn disease\n* clinical and biologic remission (normal C reactive protein and fecal calprotectin \\< 100 µg/g)\n* patient living in Grenoble area\n* informed consent form\n* social security affiliation\n\nExclusion Criteria:\n\n* Person under legal protection (articles L1121-5 and L1121-8 of Public health code)\n* Person in exclusion period of another study\n* Hypnosis contraindication'}, 'identificationModule': {'nctId': 'NCT03623932', 'acronym': 'HYPNOCROHN', 'briefTitle': 'Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease', 'orgStudyIdInfo': {'id': '38RC17.298'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'immunosuppressor/TNFalpha', 'description': 'Standard treatment with immunosuppressor and/or anti-TNFalpha treatment.', 'interventionNames': ['Drug: immunosuppressor/TNFalpha']}, {'type': 'EXPERIMENTAL', 'label': 'Hypnosis + Standard Treatment', 'description': 'Standard treatment with immunosuppressor and/or anti-TNFalpha treatment in addition to hypnosis parallel treatment.', 'interventionNames': ['Behavioral: Hypnosis']}], 'interventions': [{'name': 'immunosuppressor/TNFalpha', 'type': 'DRUG', 'description': 'Standard Treatment : immunosuppressor/TNFalpha as in standard practice', 'armGroupLabels': ['immunosuppressor/TNFalpha']}, {'name': 'Hypnosis', 'type': 'BEHAVIORAL', 'description': '8 hypnosis group sessions during 2 months', 'armGroupLabels': ['Hypnosis + Standard Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bruno BONAZ', 'role': 'CONTACT', 'email': 'BBonaz@chu-grenoble.fr'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Bruno BONAZ, PU-PH', 'role': 'CONTACT', 'email': 'BBonaz@chu-grenoble.fr', 'phone': '04 76 76 55 97'}, {'name': 'Nicolas GONNET', 'role': 'CONTACT', 'email': 'NGonnet@chu-grenoble.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}