Clinical trial NCT01906892: Creative Practice as Mutual Recovery
Official title: Creative Practice as Mutual Recovery: Connecting Communities for Mental Health and Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Individuals Experiencing Mild or Moderate Mental Health Issues
Lead sponsor: Royal College of Music
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

  1. prevent an individual from giving informed consent
  2. 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.

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre for Performance Science, Royal College of Music
Study officials:
affiliation: Royal College of Music
name: Aaron Williamon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.