Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 10:48 PM
Study NCT ID:
NCT01314768
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2011-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Intervention for Medication Overuse Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003419', 'term': 'Crisis Intervention'}, {'id': 'D003132', 'term': 'Commerce'}, {'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2011-03-14', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of medication days per month', 'timeFrame': '3 months'}, {'measure': 'Number of headache days per month', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Proportion significantly improved', 'timeFrame': '3 month', 'description': 'proportion improved \\>50% and \\>25% in terms of no headache days/month'}, {'measure': 'Headache medication days per month (diary reported)', 'timeFrame': '3 months'}, {'measure': 'Headache days/month (diary reported)', 'timeFrame': '3 months'}, {'measure': 'Average headache intensity (VAS)', 'timeFrame': '3 months'}, {'measure': 'Quality of life', 'timeFrame': '3 months'}, {'measure': 'Self-reported health related costs', 'timeFrame': '3 months'}, {'measure': 'Long term follow up of same outcomes as above plus relapse rate', 'timeFrame': '12 months'}, {'measure': 'Headache index', 'timeFrame': '3 months', 'description': 'Headache intensity x frequency x duration'}, {'measure': 'Follow up of same outcomes as for 3 months', 'timeFrame': '6 months', 'description': 'Added extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Medication-overuse Headache', 'Chronic Headache']}, 'referencesModule': {'references': [{'pmid': '30724760', 'type': 'DERIVED', 'citation': 'Lundqvist C, Gossop M, Russell MB, Straand J, Kristoffersen ES. Severity of Analgesic Dependence and Medication-overuse Headache. J Addict Med. 2019 Sep/Oct;13(5):346-353. doi: 10.1097/ADM.0000000000000504.'}, {'pmid': '28369734', 'type': 'DERIVED', 'citation': 'Kristoffersen ES, Straand J, Benth JS, Russell MB, Lundqvist C. Predictors of successful primary care detoxification treatment for medication-overuse headache. Acta Neurol Scand. 2017 Nov;136(5):486-494. doi: 10.1111/ane.12759. Epub 2017 Mar 28.'}, {'pmid': '26645391', 'type': 'DERIVED', 'citation': 'Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention by general practitioners for medication-overuse headache, follow-up after 6 months: a pragmatic cluster-randomised controlled trial. J Neurol. 2016 Feb;263(2):344-353. doi: 10.1007/s00415-015-7975-1. Epub 2015 Dec 8.'}, {'pmid': '26563095', 'type': 'DERIVED', 'citation': 'Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Disability, anxiety and depression in patients with medication-overuse headache in primary care - the BIMOH study. Eur J Neurol. 2016 Jan;23 Suppl 1:28-35. doi: 10.1111/ene.12850.'}, {'pmid': '25112307', 'type': 'DERIVED', 'citation': 'Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention for medication-overuse headache in primary care. The BIMOH study: a double-blind pragmatic cluster randomised parallel controlled trial. J Neurol Neurosurg Psychiatry. 2015 May;86(5):505-12. doi: 10.1136/jnnp-2014-308548. Epub 2014 Aug 11.'}, {'pmid': '22883540', 'type': 'DERIVED', 'citation': 'Kristoffersen ES, Straand J, Benth JS, Russell MB, Lundqvist C. Study protocol: brief intervention for medication overuse headache--a double-blinded cluster randomised parallel controlled trial in primary care. BMC Neurol. 2012 Aug 10;12:70. doi: 10.1186/1471-2377-12-70.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will perform a cluster randomised controlled study of Brief intervention (BI) for medication-overuse headache (MOH) versus business as usual. GPs will be trained to perform a structured brief intervention after identifying patients with probable MOH using the severity of dependence scale. The control arm will include patients of GPs who have not been trained in BI. Patients will be recruited by prior short postal screening of patients listed on the GPs patient lists.\n\nThe hypothesis is that BI will lead to improvement of medication-overuse and chronic headache as compared to no BI.\n\nMain outcomes are:\n\n* number of medication days per month\n* number of headache days per month\n* headache index', 'detailedDescription': '123 cases in all included (75 in intervention/placebo control arms and 48 in non-intervention Control arms) 19 did not meet predefined inclusion criteria for the different arms (5 and 8 in intervention arm and placebo arm respectively, 4 and 2 in chronic headache Control and population Control respectively)\n\n1 case was lost to follow up in each of the 4 Groups prior to first assessment. Thus 60 cases remained in intervention/placebo Control arms (24 in intervention and 36 in placebo Control) and 40 in non intervention Control arms (15 chronic headache Controls, 25 population Controls).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-50 years of age\n* Screening positive for possible chronic headache (\\> 10 headache days per month) (not for population control arm)\n* Screening positive for possible medication-overuse (\\> 15 medication days per month) (not for chronic headache control arm)\n\nExclusion Criteria:\n\n* Other complicating pain with medication treatment'}, 'identificationModule': {'nctId': 'NCT01314768', 'acronym': 'BIMOH', 'briefTitle': 'Brief Intervention for Medication Overuse Headache', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual', 'orgStudyIdInfo': {'id': 'BIMOH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Brief intervention', 'description': 'Behavioural brief intervention delivered by GP', 'interventionNames': ['Behavioral: Brief intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Business as usual', 'description': 'Business as usual according to individual GP', 'interventionNames': ['Other: Business as usual']}, {'type': 'OTHER', 'label': 'Chronic headache control', 'description': 'Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point', 'interventionNames': ['Other: Screening and outcome evaluation only']}, {'type': 'OTHER', 'label': 'Population control', 'description': 'Screening and outcome control only. Non-intervention Control, screened and followed-up at final time point', 'interventionNames': ['Other: Screening and outcome evaluation only']}], 'interventions': [{'name': 'Brief intervention', 'type': 'BEHAVIORAL', 'description': 'Structured behavioural Brief intervention given by trained GPs', 'armGroupLabels': ['Brief intervention']}, {'name': 'Business as usual', 'type': 'OTHER', 'description': 'GPs to treat patient as they have until now based on best established practice', 'armGroupLabels': ['Business as usual']}, {'name': 'Screening and outcome evaluation only', 'type': 'OTHER', 'description': 'No additional intervention', 'armGroupLabels': ['Chronic headache control']}, {'name': 'Screening and outcome evaluation only', 'type': 'OTHER', 'description': 'No additional intervention', 'armGroupLabels': ['Population control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lørenskog', 'country': 'Norway', 'facility': 'Akershus University Hospital'}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Dept of general medicine, University of Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Christofer Lundqvist, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akershus University Hospital and University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator/Project leader', 'investigatorFullName': 'Christofer Lundqvist', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}