Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-01-18 @ 1:44 PM
Study NCT ID:
NCT01468961
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2011-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2011-11-08', 'studyFirstSubmitQcDate': '2011-11-09', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Fibromyalgia Impact Questionnaire', 'timeFrame': 'Once, 1 week before start of treatment'}, {'measure': 'The Fibromyalgia Impact Questionnaire', 'timeFrame': 'Once, immediately after treatment'}, {'measure': 'The Fibromyalgia Impact Questionnaire', 'timeFrame': 'Once, 6 months after treatment'}], 'secondaryOutcomes': [{'measure': 'Short form 12-item Questionnaire', 'timeFrame': 'Once, 1 week before start of treatment'}, {'measure': 'Short form 12-item Questionnaire', 'timeFrame': 'Once, immediately after treatment'}, {'measure': 'Short form 12-item Questionnaire', 'timeFrame': 'Once, 6 months after treatment'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'Once, 1 week before start of treatment'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'Once, immediately after treatment'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'Once, 6 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '24215278', 'type': 'RESULT', 'citation': 'Ljotsson B, Atterlof E, Lagerlof M, Andersson E, Jernelov S, Hedman E, Kemani M, Wicksell RK. Internet-delivered acceptance and values-based exposure treatment for fibromyalgia: a pilot study. Cogn Behav Ther. 2014;43(2):93-104. doi: 10.1080/16506073.2013.846401. Epub 2013 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'This pilot trial will include 30-40 participants with a diagnosis of fibromyalgia. The purpose of the study is to evaluate an internet-based treatment protocol based on cognitive behavioral therapeutic principles. Participants are required to have a previous diagnosis of fibromyalgia before entering into the trial. The treatment will be 10 weeks long and all included participants will be given treatment, i.e. there is no randomization to a comparison group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current diagnosis of fibromyalgia\n\nExclusion Criteria:\n\n* Current diagnosis of severe psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT01468961', 'briefTitle': 'Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Pilot Study of Internet-based Cognitive Behavior Therapy for Fibromyalgia', 'orgStudyIdInfo': {'id': 'FIBRO-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based CBT', 'interventionNames': ['Behavioral: Internet-based CBT']}], 'interventions': [{'name': 'Internet-based CBT', 'type': 'BEHAVIORAL', 'description': '10 weeks of internet-based CBT with online therapist contact', 'armGroupLabels': ['Internet-based CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Brjann Ljotsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}