Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT00956969
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2009-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stress Management for Chronic Headaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015870', 'term': 'Gene Expression'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}], 'ancestors': [{'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-13', 'studyFirstSubmitDate': '2009-08-10', 'studyFirstSubmitQcDate': '2009-08-10', 'lastUpdatePostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache frequency and severity', 'timeFrame': 'baseline, 6-weeks, 6-months'}], 'secondaryOutcomes': [{'measure': 'Headache disability', 'timeFrame': 'baseline, 6-weeks, 6-months'}, {'measure': 'Mood, self-efficacy, stress symptoms', 'timeFrame': 'baseline and 6-weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['headaches', 'stress management', 'assertiveness training', 'relaxation training', 'emotional expression'], 'conditions': ['Headaches']}, 'descriptionModule': {'briefSummary': 'This interventional, randomized controlled study seeks to test the effects of a novel emotional awareness and expression intervention against relaxation training or no intervention for college students with chronic headaches. These two interventions are conceptually quite distinct, as the former seeks to activate and process anger, whereas the latter, more commonly used technique, seeks to suppress or avoid it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergraduate students at Wayne State University who have chronic headaches\n\nExclusion Criteria:\n\n* Insufficiently frequent headaches\n* Uninterested in engaging in a stress management intervention\n* Headaches appear due to substance use or head trauma'}, 'identificationModule': {'nctId': 'NCT00956969', 'briefTitle': 'Stress Management for Chronic Headaches', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Emotional Awareness and Expression Training and Relaxation Training for People With Chronic Headaches', 'orgStudyIdInfo': {'id': 'WSU0000001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anger awareness and expression', 'description': 'Training for anger awareness and expression', 'interventionNames': ['Behavioral: Anger Awareness and Expression']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation Training', 'description': 'Teach patients relaxation training', 'interventionNames': ['Behavioral: Relaxation Training']}, {'type': 'NO_INTERVENTION', 'label': 'No-treatment control', 'description': 'Assessment only control condition'}], 'interventions': [{'name': 'Anger Awareness and Expression', 'type': 'BEHAVIORAL', 'description': 'Teaches patients to recognize, experience, and express emotions', 'armGroupLabels': ['Anger awareness and expression']}, {'name': 'Relaxation Training', 'type': 'BEHAVIORAL', 'description': 'Teaches patients relaxation training', 'armGroupLabels': ['Relaxation Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Mark A. Lumley, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mark A. Lumley', 'investigatorAffiliation': 'Wayne State University'}}}}