Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT04867967
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2021-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Yoga and MBSR for TTH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018781', 'term': 'Tension-Type Headache'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'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': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache Frequency', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Headache Frequency self-reported by a headache diary'}], 'secondaryOutcomes': [{'measure': 'Headache Frequency', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Headache Frequency self-reported by a headache diary'}, {'measure': 'Duration of headache episodes', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Duration of headache episodes self-reported by a headache diary'}, {'measure': 'Duration of headache episodes', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Duration of headache episodes self-reported by a headache diary'}, {'measure': 'Pain Intensity', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Numeric rating scale'}, {'measure': 'Pain Intensity', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Numeric rating scale (NRS)'}, {'measure': 'Pain medication use', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Pain medication use self-reported by a headache diary'}, {'measure': 'Pain medication use', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Pain medication use self-reported by a headache diary'}, {'measure': 'Headache related disability', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Headche Impact Test 6 (HIT-6)'}, {'measure': 'Headache related disability', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Headche Impact Test 6 (HIT-6)'}, {'measure': 'Health-related quality of life', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'SF-36 questionaire'}, {'measure': 'Health-related quality of life', 'timeFrame': 'follow-up (20 weeks)', 'description': 'SF-36 questionaire'}, {'measure': 'Anxiety', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Depression and Anxiety scale (DAAS)'}, {'measure': 'Anxiety', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Depression and Anxiety scale (DAAS)'}, {'measure': 'Stress', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Depression and Anxiety scale (DAAS)'}, {'measure': 'Stress', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Depression and Anxiety scale (DAAS)'}, {'measure': 'Pain catastrophizing', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Pain catastrophizing scale (PCS)'}, {'measure': 'Pain catastrophizing', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Pain catastrophizing scale (PCS)'}, {'measure': 'Pain acceptance', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Chronic pain acceptance questionaire (CPAQ)'}, {'measure': 'Pain acceptance', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Chronic pain acceptance questionaire (CPAQ)'}, {'measure': 'Mindfulness', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Mindfulness Attention and Awerness scale (MAAS)'}, {'measure': 'Mindfulness', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Mindfulness Attention and Awerness scale (MAAS)'}, {'measure': 'Body Awareness', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Body Awareness questionaire (BAQ)'}, {'measure': 'Body Awareness', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Body Awareness questionaire (BAQ)'}, {'measure': 'Safety', 'timeFrame': 'post-intervention (8 weeks)', 'description': 'Adverse events'}, {'measure': 'Safety', 'timeFrame': 'follow-up (20 weeks)', 'description': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tension-Type Headache', 'Yoga', 'Mindfulness-based stress reduction'], 'conditions': ['Tension-Type Headache']}, 'descriptionModule': {'briefSummary': 'Primary study objectives\n\n1. evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent or chronic tension-type headache compared to routine care alone (waiting group).\n2. to evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent episodic or chronic tension-type headache compared with stress management through mindfulness-based stress reduction (MBSR) in addition to routine care.\n\nSecondary study objectives\n\nEvaluation of the medium-term effect of the intervention on headache frequency as well as the short- and medium-term effect on the secondary target parameters in comparison to the waiting group and MBSR. Further evaluation of the safety and acceptability of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* episodic or chronic tension-type headache according to ICHD-3 definition\n\nExclusion Criteria:\n\n* medication induced headache according to ICHD-3 definition\n* Cluster-headache according to ICHD-3 definition\n* serious chronic systemic or acute physical or mental illness\n* Dementia\n* Pregnancy\n* actual in a yoga or MBSR class'}, 'identificationModule': {'nctId': 'NCT04867967', 'briefTitle': 'Yoga and MBSR for TTH', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Yoga and Mindfulnes-based-stress-reduction for Patients With Tension-type Headache', 'orgStudyIdInfo': {'id': '17-7925 BO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iyengar Yoga Intervention', 'description': '8-week yoga class; once weekly; 90 minutes\n\nNote: First administered face-to-face, due to Covid-restrictions changed to online classes', 'interventionNames': ['Behavioral: Iyengar Yoga']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness-based stress reduction', 'description': '8-week MBSR class; once weekly; 90 minutes\n\nNote: First administered face-to-face, due to Covid-restrictions changed to online classes', 'interventionNames': ['Behavioral: Mindfulness-based stress reduction']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'Waitlist control, ususal care'}], 'interventions': [{'name': 'Iyengar Yoga', 'type': 'BEHAVIORAL', 'description': 'Classical Iyengar Yoga intervention, especially designed for headache patients. Note: First administered face-to-face, due to Covid-restrictions changed to online classes', 'armGroupLabels': ['Iyengar Yoga Intervention']}, {'name': 'Mindfulness-based stress reduction', 'type': 'BEHAVIORAL', 'description': 'Standardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes', 'armGroupLabels': ['Mindfulness-based stress reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45276', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Evang. Kliniken Essen-Mitte', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Gustav Dobos, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Duisburg-Essen, Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eden Stiftung', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. rer. medic', 'investigatorFullName': 'Holger Cramer', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}