Music Therapy in Methodist Homes: a Study Investigating the Impact of a Music Therapy Programme

Dementia Clinical Trial

Official title: Music Therapy in Methodist Homes: a Cluster Randomised Controlled Trial Including Mixed Methods Analysis Investigating the Efficacy of the Impact of a Music Therapy Programme on Caring for People With Dementia Who Have Behavioural Symptoms.

Status Completed

Clinical Trial Summary

The study is a cluster randomised control trial, which aims to investigate the effectiveness of music therapy in minimising Behavioural and Psychological Symptoms of Dementia (BPSD) in older adults with dementia. In particular, the study aims to identify the main components of music therapy that are key in achieving this. The study will also explore carers' perceptions of music therapy, and investigate whether carers become more attentive to patients' needs and more able to manage patients' BPSD as a result of the music therapy programme.

Clinical Trial Description

While music therapy has been noted to be an effective intervention in decreasing agitation and disruptive behaviour in adults with dementia (Livingston et al, 2005), these effects have only been demonstrated during and immediately after sessions, arguably due to the progressive nature of dementia. To achieve long-lasting therapeutic change, it seems necessary to consider the specific elements that work in music therapy, and extract them for use within other activities. It is hypothesised that the use of such elements within additional activities and care provision, alongside regular music therapy sessions, may result in decreasing residents' BPSD for a longer duration of time.

Little research has been carried out that specifically identifies the key elements of music therapy which contribute to its efficacy within the field of dementia. This study aims to support existing evidence highlighting the significance of using music therapy within dementia care, and, importantly, identify what elements are principally involved in producing changes in behaviour and levels of well-being. The study will also incorporate the collection of dementia residents' physiological data, specifically their Electrodermal Activity (EDA), during therapy sessions. This will be measured by recording participants' levels of skin conductance (microSiemens/cm); this is controlled by the Sympathetic Nervous System and roughly thought of as the Fight or Flight system. Many efforts have been made to explore how skin conductance indicates the levels of emotional arousal, for example, high skin conductance indicates excitement or stress; low skin conductance indicates sadness or calmness. (Poh et. al., 2010; 2012; Van Dooren et. al., 2012). The skin conductance data is proposed to help identify the key elements and observable phenomena of the videoed music therapy sessions showing reduced presentation of BPSD.

If the current study is able to identify such elements, these findings will enable future research to investigate more comprehensively how these can be transplanted into other activities to optimise their effects.

Participants will be recruited from two residential Methodist Homes, and using a cluster randomized control design, will be allocated to either the control group on intervention group. Participants in the control group will receive standard daily care for 22 weeks. Participants in the intervention group will, in addition to daily standard care, receive one session of individualised active music therapy once a week for a period of 22 weeks.

Music therapy sessions will last 30 minutes. During the session the participant will wear a 'Q-sensor' device around their wrist, which will record their skin conductance levels. Each session will be video-recorded.

A communication system will be employed after each therapy session, in which video clips of the session demonstrating the participant engaging in an interaction or expression will be presented to care staff. This process will aim to demonstrate to staff how Behavioural and Psychological Symptoms of Dementia (BPSD) are minimised by music therapy techniques, the possible causes of BPSD, and how the therapist has made use of the participants' remaining abilities to enhance and facilitate their involvement and interpersonal communication within sessions.

The primary outcome measure will be the Neuropsychiatric Inventory, a standardised questionnaire used to assess the psychopathology of dementia patients. This will be carried out with residents' keyworkers at the following time points: as a baseline measure in the 2 weeks prior to the commencement of the music therapy intervention period, then at weeks 11-12, weeks 21-22 and as a follow-up at weeks 27-28. There will be three secondary outcome measures:

1. dementia care mapping, an observational tool used to assess the quality of care delivered by staff. This will be carried out at baseline in the 2 weeks prior to the commencement of the music therapy intervention; then at weeks 11-12; weeks 21-22; and as a follow-up at weeks 27-28.

2. microanalysis of video recordings of music therapy sessions, in conjunction with data on participants' arousal levels during sessions, measured by a skin conductance device worn on the wrist. This will take place each week after each music therapy session for the duration of the 22 week intervention period.

3. grounded-theory based interviews. These will be carried out with care staff during weeks 23 and 25 to explore carers' perceptions of music therapy.

Further analysis of video recordings of sessions will be conducted following the completion of the 22-week period of music therapy treatment to further investigate key moments within sessions. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

• NCT number: NCT01744600
• Study type: Interventional
• Source: Methodist Homes for the Aged
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Completion date: December 2014