Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia

Last updated: February 3, 2025
Sponsor: University of Helsinki
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Treatment

Conventional music therapy (CMT)

Digital music rehabilitation (DMR)

Clinical Study ID

NCT05520268
346211
338448
803466
  • Ages > 60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed dementia (according to International Classification of Diseases [ICD]criteria), which is mild [Clinical Dementia Rating (CDR) score: 0.5-1, GlobalDeterioration Scale (GDS) score: 3-4], moderate (CDR: 2, GDS: 4-6), or severe (CDR: 3, GDS: 6-7) dementia

  • Age ≥ 60 years

  • Finnish-speaking (or bilingual; the study is performed in Finnish)

  • Stable physical and somatic condition (no major changes in psychotropic medicationduring the last 3 months)

  • Physically and cognitively able to take part in the intervention and assessments.

Exclusion

Exclusion Criteria:

  • Prior severe psychiatric illness or substance abuse

  • Major hearing or visual impairment

Study Design

Total Participants: 192
Treatment Group(s): 2
Primary Treatment: Conventional music therapy (CMT)
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University of Helsinki / Faculty of Medicine / Department of Psychology

    Helsinki, 00014
    Finland

    Active - Recruiting

  • Wilhelmiina Services

    Helsinki,
    Finland

    Site Not Available

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