Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-04-16 @ 12:31 AM
Study NCT ID:
NCT01906892
Status:
COMPLETED
Last Update Posted:
2015-11-26
First Post:
2013-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creative Practice as Mutual Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-25', 'studyFirstSubmitDate': '2013-07-16', 'studyFirstSubmitQcDate': '2013-07-21', 'lastUpdatePostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Warwick-Edinburgh Mental Well-being Scale', 'timeFrame': 'Change from baseline (recorded in the week prior to participation in either 6 or 10 weeks of music interventions) to the end of participation in the music interventions'}], 'secondaryOutcomes': [{'measure': "Secker's 'Measure of social inclusion for arts and mental health project participants'", 'timeFrame': 'Change from baseline (recorded in the week prior to participation in either 6 or 10 weeks of music interventions) to (a) the end of participation in the music interventions, and (b) 3 months after the end of music interventions'}, {'measure': 'Connor-Davidson Resilience Scale (CD-RISC)', 'timeFrame': 'Change from baseline (recorded in the week prior to participation in either 6 or 10 weeks of music interventions) to (a) the end of participation in the music interventions, and (b) 3 months after the end of music interventions'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'Change from baseline (recorded in the week prior to participation in either 6 or 10 weeks of music interventions) to (a) the end of participation in the music interventions, and (b) 3 months after the end of music interventions'}, {'measure': 'Saliva levels of cortisol', 'timeFrame': 'Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session'}, {'measure': 'Blood pressure', 'timeFrame': 'Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session'}, {'measure': 'Saliva levels of salivary immunoglobulin A', 'timeFrame': 'Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session'}, {'measure': 'Saliva levels of interleukins including IL6', 'timeFrame': 'Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session'}, {'measure': 'Heart rate', 'timeFrame': 'Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Individuals Experiencing Mild or Moderate Mental Health Issues']}, 'referencesModule': {'references': [{'pmid': '26974430', 'type': 'DERIVED', 'citation': 'Fancourt D, Perkins R, Ascenso S, Carvalho LA, Steptoe A, Williamon A. Effects of Group Drumming Interventions on Anxiety, Depression, Social Resilience and Inflammatory Immune Response among Mental Health Service Users. PLoS One. 2016 Mar 14;11(3):e0151136. doi: 10.1371/journal.pone.0151136. eCollection 2016.'}, {'pmid': '26610172', 'type': 'DERIVED', 'citation': 'Fancourt D, Perkins R, Ascenso S, Atkins L, Kilfeather S, Carvalho L, Steptoe A, Williamon A. Group Drumming Modulates Cytokine Response in Mental Health Services Users: A Preliminary Study. Psychother Psychosom. 2016;85(1):53-5. doi: 10.1159/000431257. Epub 2015 Nov 27. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "This study explores the hypothesis that mental health service users, their carers and musicians can - through the creative act of music learning and performing - mutually enhance wellbeing through the development of more meaningful and resilient lives. The project seeks to explore three interconnected issues: (i) the extent to which music learning and performing provides a forum for 'mutual recovery' among adult mental health service users, their formal/informal carers, and musicians, (ii) the characteristic features of 'mutual recovery' through music, and (iii) the underlying mechanisms of such 'mutual recovery'.\n\nThe study will consist of three different stages. Stages 1 and 2 will examine the effect of a variety of group activities - including participatory music, listening to live music, listening to recorded music and a non-music control - on psychological scales, saliva samples of stress hormones and cytokines, and subjective experience to see which provide the most relaxing, sociable and supportive environments for mutual recovery. Stage 3 will explore the impact of musical interventions over longer periods of time.\n\nA systematic review we have just carried out has revealed a major gap in research comparing different music interventions and testing the effects of different lengths of interventions. As a result, our study should help us answer the following questions:\n\n* Which aspect(s) of music can contribute to mutual recovery?\n* Do carers, patients and musicians all respond to the same activities, or do some musical activities suit certain groups more than others?\n* Do carers, patients and musicians all recover at the same rate?\n* What length of intervention is most effective?\n\nIf certain interventions are found to produce stronger results than others, these results could help guide community groups and healthcare settings in their design of music activities and have implications for the spending of arts-in-health budgets."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals of either gender and over the age of 18 who are experiencing mild or moderate mental health issues including but not limited to: stress, anxiety, depression etc.\n* Individuals of either gender and over the age of 18 who formally or informally care for mental health service users.\n* Musicians who are professional workshop leaders and music students training to be professional musicians.\n\nExclusion Criteria:\n\n* Serious mental health problems which might\n\n 1. prevent an individual from giving informed consent\n 2. cause the individual to be a disruption to other participants\n* Individuals for whom the music activity might conflict with other routine care.\n* Individuals with gum disease which would invalidate saliva samples.\n* Total deafness or severely impaired hearing.\n* Musicians or music students who apply to participate in the project but who are not deemed to have sufficient experience or expertise.'}, 'identificationModule': {'nctId': 'NCT01906892', 'briefTitle': 'Creative Practice as Mutual Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Royal College of Music'}, 'officialTitle': 'Creative Practice as Mutual Recovery: Connecting Communities for Mental Health and Wellbeing', 'orgStudyIdInfo': {'id': 'AH/K003364/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1a', 'description': '6 weeks of group drumming workshops', 'interventionNames': ['Other: Group drumming (participatory)']}, {'type': 'EXPERIMENTAL', 'label': '1b', 'description': '6 weeks of group drumming workshops', 'interventionNames': ['Other: Group drumming (participatory)']}, {'type': 'EXPERIMENTAL', 'label': '2a', 'description': '2 weeks of active group drumming followed by 2 weeks of control activity involving a literary-based activity', 'interventionNames': ['Other: Group drumming (participatory)', 'Other: Comparative activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2b', 'description': '2 weeks of the literary-based comparative activity followed by 2 weeks of watching live group drumming', 'interventionNames': ['Other: Group drumming (live)', 'Other: Comparative activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2c', 'description': '2 weeks of listening to live group drumming followed by 2 weeks of listening to recordings of group drumming', 'interventionNames': ['Other: Group drumming (live)', 'Other: Group drumming (recorded)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2d', 'description': '2 weeks of listening to recorded group drumming followed by 2 weeks of participation in group drumming', 'interventionNames': ['Other: Group drumming (participatory)', 'Other: Group drumming (recorded)']}, {'type': 'EXPERIMENTAL', 'label': '3a', 'description': '10 weeks of participatory group drumming workshops', 'interventionNames': ['Other: Group drumming (participatory)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3b', 'description': '10 weeks of engagement with other non-musical social activities', 'interventionNames': ['Other: Group drumming (participatory)']}], 'interventions': [{'name': 'Group drumming (participatory)', 'type': 'OTHER', 'description': 'Active participation in group drumming workshops', 'armGroupLabels': ['1a', '1b', '2a', '2d', '3a', '3b']}, {'name': 'Group drumming (live)', 'type': 'OTHER', 'description': 'Listening to live performances of group drumming', 'armGroupLabels': ['2b', '2c']}, {'name': 'Group drumming (recorded)', 'type': 'OTHER', 'description': 'Listening to recorded performances of group drumming', 'armGroupLabels': ['2c', '2d']}, {'name': 'Comparative activity', 'type': 'OTHER', 'description': 'Taking part in a literary-based activity', 'armGroupLabels': ['2a', '2b']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW7 2BS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Centre for Performance Science, Royal College of Music', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Aaron Williamon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal College of Music'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal College of Music', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}