Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional music therapy (CMT), Digital music rehabilitation (DMR).
- Who it may be relevant to
- Registry conditions: Dementia. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Change from baseline in the MoCA score at 3-month stage [Time frame: Baseline and 3-month stage]
- Change from baseline in the CERAD total score at 3-month stage [Time frame: Baseline and 3-month stage]
Secondary outcome measures (12)
- Change from baseline in the MoCA score at 6-month stage [Time frame: Baseline and 6-month stage]
- Change from baseline in the CERAD total score at 6-month stage [Time frame: Baseline and 6-month stage]
- Change from baseline in the MoCA Fluency score at 3-month and 6-month stages [Time frame: Baseline, 3-month stage and 6-month stage]
- Change from baseline in the CERAD Fluency score at 3-month and 6-month stages [Time frame: Baseline, 3-month stage and 6-month stage]
- Change from baseline in the CERAD Naming score at 3-month and 6-month stages [Time frame: Baseline, 3-month stage and 6-month stage]
- Change from baseline in the CERAD Constructional Praxis score at 3-month and 6-month stages [Time frame: Baseline, 3-month stage and 6-month stage]
- Change from baseline in the CERAD Word List Learning score at 3-month and 6-month stages [Time frame: Baseline, 3-month stage and 6-month stage]
- Change from baseline in the CERAD Word List Recall score at 3-month and 6-month stages [Time frame: Baseline, 3-month stage and 6-month stage]
- Change from baseline in the CERAD Word List Recognition score at 3-month and 6-month stages [Time frame: Baseline, 3-month stage and 6-month stage]
- Change from baseline in the WMS-IV Logical Memory I score at 3-month and 6-month stages [Time frame: Baseline, 3-month stage and 6-month stage]
- Change from baseline in the WMS-IV Logical Memory II score at 3-month and 6-month stages [Time frame: Baseline, 3-month stage and 6-month stage]
- Change from baseline in the IFS total score at 3-month and 6-month stages [Time frame: Baseline, 3-month stage and 6-month stage]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Finland · 1 center
- University of Helsinki / Faculty of Medicine / Department of Psychology — Helsinki
Identifiers
NCT: NCT05520268 · 346211 · 338448 · 803466