Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-24 @ 9:59 AM
Study NCT ID:
NCT02800720
Status:
COMPLETED
Last Update Posted:
2016-06-15
First Post:
2016-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'lastUpdateSubmitDate': '2016-06-09', 'studyFirstSubmitDate': '2016-06-06', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revised Fibromyalgia Impact Questionnaire', 'timeFrame': '8 weeks', 'description': 'Scale Reference: Bennett, Friend, Jones, Ward, Han \\& Ross (2009)'}, {'measure': 'Short Form McGill Pain Questionnaire', 'timeFrame': '8 weeks', 'description': 'Scale Reference: Melzack (1987)'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '8 weeks', 'description': 'Scale Reference: Buysse, Reynolds Monk, Berman, \\& Kupfer (1989)'}, {'measure': 'Depression Anxiety and Stress Scale', 'timeFrame': '8 weeks', 'description': 'Scale Reference: Lovibond \\& Lovibond (1995)'}]}, 'conditionsModule': {'keywords': ['Fibromyalgia Syndromey'], 'conditions': ['Fibromyalgia Syndrome']}, 'referencesModule': {'availIpds': [{'url': 'http://link.springer.com/article/10.1007/s12671-015-0458-8', 'type': 'Embedded Qualitative Study'}]}, 'descriptionModule': {'briefSummary': 'A Randomised Controlled Trial to evaluate the effectiveness of a Second-Generation Mindfulness-Based Intervention known as Meditation Awareness Training (MAT) for treating fibromyalgia syndrome.', 'detailedDescription': 'Background: Fibromyalgia syndrome (FMS) is a chronic pain disorder that frequently leads to poor quality of life. The need for more effective FMS treatments has prompted empirical investigations into the applications of mindfulness for treating the condition. However, studies have predominantly focused on first-generation mindfulness-based interventions (FG-MBIs). To date, a randomised controlled trial (RCT) assessing the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating FMS has not been undertaken. SG-MBIs are distinct from FG-MBIs because they are overtly spiritual in nature and employ (i) a greater range of (normally secularised) meditative/spiritual techniques, (ii) ethics as a key component of the taught programme, and (iii) an instructor training programme that typically requires several years of supervised mindfulness practice.\n\nAims: To evaluate the effectiveness of Meditation Awareness Training (MAT) - an SG-MBI - for treating FMS.\n\nMethod: Adults with FMS will receive MAT or an active control intervention known as Cognitive-Behavioural Therapy for Groups. Assessments will be performed at pre-intervention, post-intervention, and follow-up phases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current diagnosis of fibromyalgia syndrome\n* Aged between 18 and 65 years\n* Able to read and write using the English language\n* Available to complete an eight-week intervention and six-month follow-up assessment\n\nExclusion Criteria:\n\n* Currently undergoing formal psychotherapy\n* Changes in psychopharmacology type or dosage one-month prior to intervention\n* Currently practicing mindfulness or meditation'}, 'identificationModule': {'nctId': 'NCT02800720', 'briefTitle': 'Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Nottingham Trent University'}, 'officialTitle': 'Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'NTU-MATFMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditation Awareness Training', 'description': 'Target Intervention Arm:\n\n8-week meditation intervention', 'interventionNames': ['Behavioral: Meditation Awareness Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioural Therapy for Groups', 'description': 'Active Comparator Arm:\n\n8-week CBT-based intervention', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Groups']}], 'interventions': [{'name': 'Meditation Awareness Training', 'type': 'BEHAVIORAL', 'description': '8 Week Meditation Intervention', 'armGroupLabels': ['Meditation Awareness Training']}, {'name': 'Cognitive Behavioral Therapy for Groups', 'type': 'BEHAVIORAL', 'description': '8 week intervention based on Cognitive Behavioral Theory', 'armGroupLabels': ['Cognitive Behavioural Therapy for Groups']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'William Van Gordon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottingham Trent University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nottingham Trent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'William Van Gordon', 'investigatorAffiliation': 'Nottingham Trent University'}}}}