Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia

NCT05520268 | Recruiting

• 3 other identifiers: 346211338448803466
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

music therapy; music-based rehabilitation; digital intervention; cognitive functioning; memory; emotion; mood; quality of life; electroencephalography; magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the MoCA score at 3-month stage

  Montreal Cognitive Assessment (MoCA) score (range 0-30, higher score indicates better outcome), measures general cognitive function

  Baseline and 3-month stage

• Change from baseline in the CERAD total score at 3-month stage

  Consortium to Establish a Registry for Alzheimer's Disease (CERAD) total score (Chandler score, range 0-100, higher score indicates better outcome), measures general cognitive function

  Baseline and 3-month stage

Secondary Outcomes (28)

• Change from baseline in the MoCA score at 6-month stage

  Baseline and 6-month stage

• Change from baseline in the CERAD total score at 6-month stage

  Baseline and 6-month stage

• Change from baseline in the MoCA Fluency score at 3-month and 6-month stages

  Baseline, 3-month stage and 6-month stage

• Change from baseline in the CERAD Fluency score at 3-month and 6-month stages

  Baseline, 3-month stage and 6-month stage

• Change from baseline in the CERAD Naming score at 3-month and 6-month stages

  Baseline, 3-month stage and 6-month stage

Other Outcomes (6)

• Association between baseline demographic and musical background factors and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)

  Baseline

• Association between baseline music cognition indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)

  Baseline

• Association between baseline ERP indices and change in primary/secondary outcome measures (from baseline to 3-month and 6-month stages)

  Baseline

Study Arms (3)

Conventional music therapy (CMT)

EXPERIMENTAL

Participants receive 10 weeks of CMT and standard care.

Behavioral: Conventional music therapy (CMT)

Digital music rehabilitation (DMR)

EXPERIMENTAL

Participants receive 10 weeks of DMR and standard care.

Behavioral: Digital music rehabilitation (DMR)

Standard care

NO INTERVENTION

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

Interventions

Conventional music therapy (CMT) BEHAVIORAL

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.

Conventional music therapy (CMT)

Digital music rehabilitation (DMR) BEHAVIORAL

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.

Digital music rehabilitation (DMR)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Helsinki: lead
• Helsinki University Central Hospital: collaborator
• City of Helsinki: collaborator

Study Sites (1)

University of Helsinki / Faculty of Medicine / Department of Psychology

Helsinki, 00014, Finland

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Teppo Särkämö, PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anni Pitkäniemi, MA

CONTACT

+358503115872; anni.pitkaniemi@helsinki.fi

Lotta Ahveninen, MSci

CONTACT

+358503009564; lotta.ahveninen@helsinki.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 29, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FI (1)