protocolSection identificationModule nctId: NCT06322485, orgStudyIdInfo id: P16.230, briefTitle: Online Self-management in Fibromyalgia, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01-25, primaryCompletionDateStruct date: 2021-01-26, completionDateStruct date: 2021-01-26, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Leiden University, class: OTHER, collaborators name: Fibrocentrum, descriptionModule briefSummary: This study has been previously registered with the National Trial Registry (NTR6267) that has been cancelled. The registered trial has been automatically transferred to a new "Landelijk Trial Register", which does not contain all correct information on the current study and where no corrections can be made. Hence, the current study has been registered again with ClinicalTrials.gov.The goal of this clinical trial is to study the effectiveness of an internet-based self-management intervention in adult patients with fibromyalgia. A randomized controlled trial (RCT) will be performed, in which 70 participants will be randomized to either the self-management intervention or a waitlist control condition (patients in the waitlist condition will receive the intervention after the intervention ends in the intervention group, i.e., after 6 months). The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention. As secondary outcomes, a number of other psychological and physical outcome measures will be assessed (e.g., health-related quality of life, well-being, pain impact on daily life, pain cognitions). Also, cost-effectiveness of the intervention and the quality of the therapeutic relationship will be measured., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Blinding of participants and practitioners is not possible due to the nature of the study. However, the statistician who creates the randomization schedule and performs statistical analyses is blinded to group allocation., enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Internet-based self-management intervention, outcomesModule primaryOutcomes measure: Change in pain coping, secondaryOutcomes measure: Change in well-being, secondaryOutcomes measure: Change in illness cognitions, secondaryOutcomes measure: Change in pain coping strategies, secondaryOutcomes measure: Change in Illness Perceptions, secondaryOutcomes measure: Change in pain, secondaryOutcomes measure: Change in pain interference in daily functioning and pain severity, and as exploratory measures support, life control, and affective distress, secondaryOutcomes measure: Change in health-related quality of life, secondaryOutcomes measure: Change in fibromyalgia impact, secondaryOutcomes measure: Change in health-related quality of life, otherOutcomes measure: Economic evaluation: Five-Level Version of the EQ-5D (EQ-5D-5L), otherOutcomes measure: Economic evaluation: iMTA Medical Consumption Questionnaire (iMCQ), otherOutcomes measure: Economic evaluation: iMTA Productivity Cost Questionnaire (iPCQ), otherOutcomes measure: Patient satisfaction, otherOutcomes measure: Expected/perceived patient-provider interaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fibrocentrum, city: Leiden, state: Zuid-Holland, zip: 2321 GL, country: Netherlands, geoPoint lat: 52.15833, lon: 4.49306, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2022-07-25, uploadDate: 2023-11-27T05:27, filename: SAP_000.pdf, size: 109827, hasResults: False