Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia
- Conditions
- Dementia
- Interventions
- Behavioral: Conventional music therapy (CMT)Behavioral: Digital music rehabilitation (DMR)
- Registration Number
- NCT05520268
- Lead Sponsor
- University of Helsinki
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 192
- 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.
- Prior severe psychiatric illness or substance abuse
- Major hearing or visual impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional music therapy (CMT) Conventional music therapy (CMT) Participants receive 10 weeks of CMT and standard care. Digital music rehabilitation (DMR) Digital music rehabilitation (DMR) Participants receive 10 weeks of DMR and standard care.
- Primary Outcome Measures
Name Time Method Change from baseline in the MoCA score at 3-month stage Baseline and 3-month stage Montreal Cognitive Assessment (MoCA) score (range 0-30, higher score indicates better outcome), measures general cognitive function
Change from baseline in the CERAD total score at 3-month stage Baseline and 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
- Secondary Outcome Measures
Name Time Method Change from baseline in the MoCA Fluency score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Montreal Cognitive Assessment (MoCA) Fluency subtest score (phonemic fluency; min: 0, max: no upper limit, higher score indicates better outcome), measures language skills
Change from baseline in the CERAD Naming score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Naming subtest score (range: 0-15, higher score indicates better outcome), measures language skills
Change from baseline in the WMS-IV Logical Memory I score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Wechsler Memory Scale IV (WMS-IV) Logical Memory I subtest score (range: 0-56, higher score indicates better outcome), measures immediate verbal recall
Change from baseline in the CERAD total score at 6-month stage Baseline and 6-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
Change from baseline in the CERAD Word List Recall score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List Recall subtest score (range: 0-10, higher score indicates better outcome), measures delayed spontaneous verbal recall
Change from baseline in the NPI-Q Severity score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity scale score (range 0-36, higher score indicates worse outcome), measures the severity of neuropsychiatric symptoms
Change from baseline in the MoCA score at 6-month stage Baseline and 6-month stage Montreal Cognitive Assessment (MoCA) score (range 0-30, higher score indicates better outcome), measures general cognitive function
Change from baseline in the CERAD Word List Learning score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List Learning subtest score (range: 0-30, higher score indicates better outcome), measures verbal learning
Change from baseline in the CERAD Word List Recognition score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List Recognition subtest score (range: 0-20, higher score indicates better outcome), measures delayed cued verbal recall
Change from baseline in the MADRS score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Montgomery-Åsberg Depression Rating Scale (MADRS) score (range 0-60, higher score indicates worse outcome), measures depression symptoms
Change from baseline in the PROMIS Depression score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scale score (range 8-40, higher score indicates worse outcome), measures depression symptoms
Change from baseline in the UWES-9 score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Utrecht Work Engagement Scale 9 (UWES-9) score (nurse self-report; range 0-54, higher score indicates better outcome), measures occupational well-being
Change from baseline in the CERAD Fluency score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Fluency subtest score (semantic fluency; min: 0, max: no upper limit, higher score indicates better outcome), measures language skills
Change from baseline in the WMS-IV Logical Memory II score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Wechsler Memory Scale IV (WMS-IV) Logical Memory II subtest score (range: 0-28, higher score indicates better outcome), measures delayed verbal recall
Change from baseline in autobiographical memory score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Custom-made autobiographical memory questionnaire, percentage score (range 0-100, higher score indicates better outcome; also qualitative data collected), measures subjective and objective autobiographical memory
Change from baseline in the NPI-Q Distress score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Neuropsychiatric Inventory Questionnaire (NPI-Q) Distress scale score (range 0-60, higher score indicates worse outcome), measures the distress caused by the neuropsychiatric symptoms on caregivers
Change from baseline in the caregiver ZBI-12 score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Zarit Burden Interview 12 (ZBI-12) score (caregiver self-report; range 0-48, higher score indicates worse outcome), measures caregiver burden
Change from baseline in the CERAD Constructional Praxis score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Constructional Praxis subtest score (range: 0-11, higher score indicates better outcome), measures visuoconstructive function
Change from baseline in the IFS total score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage INECO Frontal Screening (IFS) total score (range 0-30, higher score indicates better outcome), measures executive function and working memory
Change from baseline in the IFS Working memory subscore at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage INECO Frontal Screening (IFS) Working memory subscore (summary score of the Digits Backward, Verbal Working Memory and Spatial Working Memory subtests, range 0-12, higher score indicates better outcome), measures working memory
Change from baseline in the NPI-Q total score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Neuropsychiatric Inventory Questionnaire (NPI-Q) total score (range 0-180, calculated as Severity x Distress, higher score indicates worse outcome), measures the total level of neuropsychiatric symptoms
Change from baseline in the QoL-AD score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Quality of Life in Alzheimer's Disease (QoL-AD) score (range 15-60, higher score indicates better outcome), measures quality of life
Change from baseline in the EuroQol EQ-5D-5L Health index score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage EuroQol EQ-5D-5L Health index score (range 0-1, higher score indicates better outcome), measures health-related quality of life
Change from baseline in the caregiver GHQ-12 score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage General Health Questionnaire 12 (GHQ-12) score (caregiver self-report; range 0-36, higher score indicates worse outcome), measures stress and psychological well-being
Change from baseline in the IFS Executive subscore at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage INECO Frontal Screening (IFS) Executive subscore (summary score of the Motor Series, Conflicting Instructions, Go-No Go, Proverbs and Hayling Test subtests, range 0-18, higher score indicates better outcome), measures executive function
Change from baseline in the PROMIS Anxiety score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scale score (range 8-40, higher score indicates worse outcome), measures anxiety symptoms
Change from baseline in the PCTB score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage Professional Care Team Burden (PCTB) score (nurse self-report; range 0-40, higher score indicates worse outcome), measures professional care team burden
Change from baseline in the EuroQol EQ-5D-5L Health VAS score at 3-month and 6-month stages Baseline, 3-month stage and 6-month stage EuroQol EQ-5D-5L Health VAS score (range 0-100, higher score indicates better outcome), measures general health
Trial Locations
- Locations (1)
University of Helsinki / Faculty of Medicine / Department of Psychology
🇫🇮Helsinki, Finland