NCT01906892

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

1.1 years

First QC Date

July 16, 2013

Last Update Submit

November 25, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Warwick-Edinburgh Mental Well-being Scale

    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'

    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)

    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

    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

    Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session

  • Blood pressure

    Change from baseline (taken immediately before the music intervention) when measured immediately following the 60 or 90 minute music intervention session

  • +3 more secondary outcomes

Study Arms (8)

1a

EXPERIMENTAL

6 weeks of group drumming workshops

Other: Group drumming (participatory)

1b

EXPERIMENTAL

6 weeks of group drumming workshops

Other: Group drumming (participatory)

2a

EXPERIMENTAL

2 weeks of active group drumming followed by 2 weeks of control activity involving a literary-based activity

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

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

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

Other: Group drumming (participatory)Other: Group drumming (recorded)

3a

EXPERIMENTAL

10 weeks of participatory group drumming workshops

Other: Group drumming (participatory)

3b

ACTIVE COMPARATOR

10 weeks of engagement with other non-musical social activities

Other: Group drumming (participatory)

Interventions

Active participation in group drumming workshops

1a1b2a2d3a3b

Listening to live performances of group drumming

2b2c

Listening to recorded performances of group drumming

2c2d

Taking part in a literary-based activity

2a2b

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Performance Science, Royal College of Music

London, SW7 2BS, United Kingdom

Location

Related Publications (2)

  • 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 Officials

  • Aaron Williamon, PhD

    Royal College of Music

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 24, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations