Clinical trial NCT05520268: Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia
Official title: Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Keywords: music therapy
music-based rehabilitation
digital intervention
cognitive functioning
memory
emotion
mood
quality of life
electroencephalography
magnetic resonance imaging
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: City of Helsinki
First posted: 2022-08-29
Enrollment: 192
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Change from baseline in the MoCA score at 3-month stage
timeFrame: Baseline and 3-month stage
measure: Change from baseline in the CERAD total score at 3-month stage
timeFrame: Baseline and 3-month stage
Secondary outcomes:
measure: Change from baseline in the MoCA score at 6-month stage
timeFrame: Baseline and 6-month stage
measure: Change from baseline in the CERAD total score at 6-month stage
timeFrame: Baseline and 6-month stage
measure: Change from baseline in the MoCA Fluency score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the CERAD Fluency score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the CERAD Naming score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the CERAD Constructional Praxis score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the CERAD Word List Learning score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the CERAD Word List Recall score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the CERAD Word List Recognition score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the WMS-IV Logical Memory I score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the WMS-IV Logical Memory II score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the IFS total score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the IFS Executive subscore at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the IFS Working memory subscore at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in autobiographical memory score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the MADRS score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the PROMIS Depression score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the PROMIS Anxiety score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the NPI-Q Severity score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the NPI-Q Distress score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the NPI-Q total score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the QoL-AD score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the EuroQol EQ-5D-5L Health index score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the EuroQol EQ-5D-5L Health VAS score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the caregiver GHQ-12 score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the caregiver ZBI-12 score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the UWES-9 score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
measure: Change from baseline in the PCTB score at 3-month and 6-month stages
timeFrame: Baseline, 3-month stage and 6-month stage
Other outcomes:
measure: Association between baseline demographic and musical background factors and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)
timeFrame: Baseline
measure: Association between baseline music cognition indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)
timeFrame: Baseline
measure: Association between baseline ERP indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)
timeFrame: Baseline
measure: Association between baseline sMRI indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)
timeFrame: Baseline
measure: Association between baseline dMRI indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)
timeFrame: Baseline
measure: Association between baseline fMRI indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)
timeFrame: Baseline
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki / Faculty of Medicine / Department of Psychology
Study officials:
affiliation: University of Helsinki
name: Teppo Särkämö, PhD
role: PRINCIPAL_INVESTIGATOR
References: