- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01906892
Creative Practice as Mutual Recovery
Creative Practice as Mutual Recovery: Connecting Communities for Mental Health and Wellbeing
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'.
The 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.
A 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:
- Which aspect(s) of music can contribute to mutual recovery?
- Do carers, patients and musicians all respond to the same activities, or do some musical activities suit certain groups more than others?
- Do carers, patients and musicians all recover at the same rate?
- What length of intervention is most effective?
If 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.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom, SW7 2BS
- Centre for Performance Science, Royal College of Music
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- Individuals of either gender and over the age of 18 who formally or informally care for mental health service users.
- Musicians who are professional workshop leaders and music students training to be professional musicians.
Exclusion Criteria:
Serious mental health problems which might
- prevent an individual from giving informed consent
- cause the individual to be a disruption to other participants
- Individuals for whom the music activity might conflict with other routine care.
- Individuals with gum disease which would invalidate saliva samples.
- Total deafness or severely impaired hearing.
- Musicians or music students who apply to participate in the project but who are not deemed to have sufficient experience or expertise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1a
6 weeks of group drumming workshops
|
Active participation in group drumming workshops
|
Experimental: 1b
6 weeks of group drumming workshops
|
Active participation in group drumming workshops
|
Experimental: 2a
2 weeks of active group drumming followed by 2 weeks of control activity involving a literary-based activity
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Active participation in group drumming workshops
Taking part in a literary-based activity
|
Active Comparator: 2b
2 weeks of the literary-based comparative activity followed by 2 weeks of watching live group drumming
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Taking part in a literary-based activity
Listening to live performances of group drumming
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Active Comparator: 2c
2 weeks of listening to live group drumming followed by 2 weeks of listening to recordings of group drumming
|
Listening to live performances of group drumming
Listening to recorded performances of group drumming
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Active Comparator: 2d
2 weeks of listening to recorded group drumming followed by 2 weeks of participation in group drumming
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Active participation in group drumming workshops
Listening to recorded performances of group drumming
|
Experimental: 3a
10 weeks of participatory group drumming workshops
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Active participation in group drumming workshops
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Active Comparator: 3b
10 weeks of engagement with other non-musical social activities
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Active participation in group drumming workshops
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Warwick-Edinburgh Mental Well-being Scale
Time Frame: 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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secker's 'Measure of social inclusion for arts and mental health project participants'
Time Frame: 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
|
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
|
Connor-Davidson Resilience Scale (CD-RISC)
Time Frame: 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
|
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
|
Hospital Anxiety and Depression Scale
Time Frame: 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
|
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
|
Saliva levels of cortisol
Time Frame: Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
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Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
|
Blood pressure
Time Frame: Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
|
Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
|
Saliva levels of salivary immunoglobulin A
Time Frame: Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
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Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
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Saliva levels of interleukins including IL6
Time Frame: Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
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Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
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Heart rate
Time Frame: Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
|
Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aaron Williamon, PhD, Royal College of Music
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AH/K003364/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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