Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia

University of Helsinki

Status: Enrolling

Conditions: Dementia

Treatments: Behavioral: Conventional music therapy (CMT); Behavioral: Digital music rehabilitation (DMR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05520268

346211

338448 (Other Grant/Funding Number)

803466 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 192 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosed dementia (according to International Classification of Diseases [ICD] criteria), which is mild [Clinical Dementia Rating (CDR) score: 0.5-1, Global Deterioration 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 medication during the last 3 months)
• Physically and cognitively able to take part in the intervention and assessments.

Exclusion criteria

• Prior severe psychiatric illness or substance abuse
• Major hearing or visual impairment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

192 participants in 3 patient groups

Conventional music therapy (CMT)

Experimental group

Description:

Participants receive 10 weeks of CMT and standard care.

Treatment:

Behavioral: Conventional music therapy (CMT)

Digital music rehabilitation (DMR)

Experimental group

Description:

Participants receive 10 weeks of DMR and standard care.

Treatment:

Behavioral: Digital music rehabilitation (DMR)

Standard care

No Intervention group

Description:

Participants receive only standard care. Standard care comprises normal care services received by the PWDs in the Finnish health care system.