Individuals Experiencing Mild or Moderate Mental Health IssuesNCT01906892
Creative Practice as Mutual Recovery
A study testing Group drumming (participatory), Group drumming (live) and Group drumming (recorded) in people with Individuals Experiencing Mild or Moderate Mental Health Issues, run by Royal College of Music at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Individuals Experiencing Mild or Moderate Mental Health Issues
- What is being tested?
- Group drumming (participatory), Group drumming (live) and Group drumming (recorded)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Performance Science, Royal College of Music
London, SW7 2BS
About this study
Official title: 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.
Read more
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.
- Being tested
- Group drumming (participatory), Group drumming (live), Group drumming (recorded), Comparative activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group drumming (participatory)Other
Active participation in group drumming workshops
Group drumming (live)Other
Listening to live performances of group drumming
Group drumming (recorded)Other
Listening to recorded performances of group drumming
Comparative activityOther
Taking part in a literary-based activity
| Study group | Role | What they receive |
|---|---|---|
| 1a | Experimental | 6 weeks of group drumming workshops Receives: Other: Group drumming (participatory) |
| 1b | Experimental | 6 weeks of group drumming workshops Receives: Other: Group drumming (participatory) |
| 2a | Experimental | 2 weeks of active group drumming followed by 2 weeks of control activity involving a literary-based activity Receives: Other: Group drumming (participatory); Other: Comparative activity |
| 2b | Active comparator | 2 weeks of the literary-based comparative activity followed by 2 weeks of watching live group drumming Receives: Other: Group drumming (live); Other: Comparative activity |
| 2c | Active comparator | 2 weeks of listening to live group drumming followed by 2 weeks of listening to recordings of group drumming Receives: Other: Group drumming (live); Other: Group drumming (recorded) |
| 2d | Active comparator | 2 weeks of listening to recorded group drumming followed by 2 weeks of participation in group drumming Receives: Other: Group drumming (participatory); Other: Group drumming (recorded) |
| 3a | Experimental | 10 weeks of participatory group drumming workshops Receives: Other: Group drumming (participatory) |
| 3b | Active comparator | 10 weeks of engagement with other non-musical social activities Receives: Other: Group drumming (participatory) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Warwick-Edinburgh Mental Well-being Scale
Measured: 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 outcomes (8)
Secker's 'Measure of social inclusion for arts and mental health project participants'
Measured: 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)
Measured: 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
Measured: 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
Measured: Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
Blood pressure
Measured: 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
Measured: Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
Saliva levels of interleukins including IL6
Measured: Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
Heart rate
Measured: Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Individuals Experiencing Mild or Moderate Mental Health IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Music
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Williamon, PhD, Principal investigator, Royal College of Music
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906892
- Sponsor's protocol ID
- AH/K003364/1
- Status last verified
- Nov 2015
- First submitted
- 16 Jul 2013
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26974430Fancourt 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.
PubMed 26610172
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creative Practice as Mutual Recovery: Connecting Communities for Mental Health and Wellbeing
- ClinicalTrials.gov ID
- NCT01906892
- Acronym / sponsor ID
- AH/K003364/1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Royal College of MusicUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1a | Experimental | Other: Group drumming (participatory)6 weeks of group drumming workshops |
| 1b | Experimental | Other: Group drumming (participatory)6 weeks of group drumming workshops |
| 2a | Experimental | Other: Group drumming (participatory), Other: Comparative activity2 weeks of active group drumming followed by 2 weeks of control activity involving a literary-based activity |
| 2b | Active comparator | Other: Group drumming (live), Other: Comparative activity2 weeks of the literary-based comparative activity followed by 2 weeks of watching live group drumming |
| 2c | Active comparator | Other: Group drumming (live), Other: Group drumming (recorded)2 weeks of listening to live group drumming followed by 2 weeks of listening to recordings of group drumming |
| 2d | Active comparator | Other: Group drumming (participatory), Other: Group drumming (recorded)2 weeks of listening to recorded group drumming followed by 2 weeks of participation in group drumming |
| 3a | Experimental | Other: Group drumming (participatory)10 weeks of participatory group drumming workshops |
| 3b | Active comparator | Other: Group drumming (participatory)10 weeks of engagement with other non-musical social activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Serious mental health problems which might
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group drumming (participatory)Active participation in group drumming workshops | Other | 1a, 1b, 2a, 2d, 3a, 3b |
| Group drumming (live)Listening to live performances of group drumming | Other | 2b, 2c |
| Group drumming (recorded)Listening to recorded performances of group drumming | Other | 2c, 2d |
| Comparative activityTaking part in a literary-based activity | Other | 2a, 2b |
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
- Derived from this study: PubMed 26974430Fancourt 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.
- Derived from this study: PubMed 26610172Fancourt 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Williamon, PhD principal investigator
Royal College of Music
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group drumming (participatory), Group drumming (live) and Group drumming (recorded) in people with Individuals Experiencing Mild or Moderate Mental Health Issues, run by Royal College of Music at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01906892, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.