Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-01 @ 11:00 PM
Study NCT ID:
NCT00997451
Status:
COMPLETED
Last Update Posted:
2012-10-01
First Post:
2009-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fatigue Self-Management in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-28', 'studyFirstSubmitDate': '2009-03-28', 'studyFirstSubmitQcDate': '2009-10-16', 'lastUpdatePostDateStruct': {'date': '2012-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Severity Scale', 'timeFrame': '3 months, 6 months, 15 months'}], 'secondaryOutcomes': [{'measure': 'Beck Anxiety Inventory', 'timeFrame': '3 months, 6 months, 15 months'}, {'measure': 'Beck Depression Inventory', 'timeFrame': '3 months, 6 months, 15 months'}, {'measure': 'SF-36 physical function subscale', 'timeFrame': '3 months, 6 months, 15 months'}, {'measure': 'Global Impression of Change Rating', 'timeFrame': '3 months, 6 months, 15 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medically unexplained chronic fatigue', 'Chronic fatigue syndrome', 'Cognitive-behavior therapy', 'Self-management', 'Primary care', 'Nurses', 'Economic analysis', 'Cost effectiveness', 'One year follow-up'], 'conditions': ['Medically Unexplained Chronic Fatigue', 'Chronic Fatigue Syndrome']}, 'referencesModule': {'references': [{'pmid': '25421363', 'type': 'DERIVED', 'citation': 'Meng H, Friedberg F, Castora-Binkley M. Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial. BMC Fam Pract. 2014 Nov 25;15:184. doi: 10.1186/s12875-014-0184-7.'}, {'pmid': '23922399', 'type': 'DERIVED', 'citation': 'Friedberg F, Napoli A, Coronel J, Adamowicz J, Seva V, Caikauskaite I, Ngan MC, Chang J, Meng H. Chronic fatigue self-management in primary care: a randomized trial. Psychosom Med. 2013 Sep;75(7):650-7. doi: 10.1097/PSY.0b013e31829dbed4. Epub 2013 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. The hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of unexplained chronic fatigue\n* diagnosis of chronic fatigue syndrome\n\nExclusion Criteria:\n\n* medically explained fatigue\n* any psychosis or dementia'}, 'identificationModule': {'nctId': 'NCT00997451', 'briefTitle': 'Fatigue Self-Management in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics', 'orgStudyIdInfo': {'id': 'NIH 5R01NR010229 - 03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Self-Management', 'description': 'Cognitive-behavioral self-management', 'interventionNames': ['Behavioral: Cognitive-behavioral self-management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Symptom Monitoring', 'interventionNames': ['Behavioral: Symptom monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Medical Care'}], 'interventions': [{'name': 'Cognitive-behavioral self-management', 'type': 'BEHAVIORAL', 'description': 'Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.', 'armGroupLabels': ['Behavioral Self-Management']}, {'name': 'Symptom monitoring', 'type': 'BEHAVIORAL', 'description': 'Daily symptom via web diary', 'armGroupLabels': ['Symptom Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Fred Friedberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}