NCT05520268

Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: University of Helsinki · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in home and care home settings.

Detailed description

Rationale: In persons with dementia (PWDs), music-based interventions have shown positive effects on emotional, behavioural and cognitive symptoms as well as on psychological well-being and quality of life. Despite the evidence for the efficacy of music in PWDs, many issues surround the practicalities of music interventions, especially regarding their applicability, scalability, and optimization across the dementia care continuum. Moreover, the individual factors affecting the treatment outcomes of music-based interventions remain largely unexplored in dementia. Aims: The purpose of this randomized controlled trial (RCT) is to determine the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in both home and care home settings. Specifically, the RCT seeks to determine (i) can conventional music therapy (CMT) and digital music rehabilitation (DMR) enhance or support cognitive function, mood, and quality of life in dementia compared to standard care; (ii) how does the efficacy of CMT and DMR differ in the different stages of dementia; and (iii) how do baseline demographic factors (e.g., age, gender, education), musical factors (musical background, music cognition) and neural factors (e.g., extent of neuropathology, preservation of music networks) affect the efficacy of the music interventions. Methods: Participants are 192 PWDs across the dementia care continuum (PWDs with mild-moderate dementia living at home and PWDs with moderate-severe dementia living in care homes; N=96 each). Following a three-arm parallel-group RCT design, the PWDs living at home and at care homes are randomized into three groups (CMT, DMR, standard care; N=32 each\]. The CMT and DMR comprise passive and active engagement with music over 10 weeks (2x60 min sessions/week), implemented either by a music therapist (CMT) or using a novel digital music content service (DMR). To investigate the efficacy of the music interventions, participants complete measures of cognitive functioning (neuropsychological tests) and mood and quality of life (questionnaires, clinical scales), which are assessed at three time points: baseline (pre-intervention), 3-month stage (post-intervention) and 6-month stage (follow-up). Additionally, family member and caregivers of PWDs are asked to answer questionnaires on the psychological well-being of the PWD (informant-report) and themselves (self-report). To explore the individual musical and neural factors that may affect the efficacy of music interventions, participants also complete a musical assessment battery as well as electroencephalography (EEG) and structural and functional MRI (s/fMRI) measurements at baseline.

Conditions

• Dementia

Interventions

Type	Name	Description
BEHAVIORAL	Conventional music therapy (CMT)	CMT comprises both receptive and expressive musical activities (listening and reminiscing to music, singing, and moving to music) held in small groups (8 PWDs/group) for a duration of 10 weeks (2x60 min sessions/week) and led by a professional music therapist. For PWDs living in a care home, the CMT sessions are implemented as inpatient rehabilitation held at the care home. For PWDs living at home, the CMT sessions are implemented as outpatient rehabilitation held at a local day activity centre.
BEHAVIORAL	Digital music rehabilitation (DMR)	DMR comprises both receptive and expressive musical activities (listening and reminiscing to music, singing, and moving to music) held in small groups (8 PWDs/group) for a duration of 10 weeks (2x60 min sessions/week) and implemented using a novel digital music content service called HILDA. In HILDA, there are a number of stand-alone musical programs hosted by a virtual presenter which the PWDs can follow and through which they can interact. The DMR sessions are moderated by an instructor (care home staff member or research assistant). For PWDs living in a care home, the DMR is implemented as live sessions held at the care home using a HILDA box connected to a TV screen and operated via a remote controller by the instructor. For PWDs living at home, the DMR is implemented as virtual sessions using a video communication platform that allows the instructor to stream and control the HILDA service and the participants to see and hear each other and interact.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-08-29
• Last updated: 2025-02-06

Locations

1 site across 1 country: Finland