Efficacy of Music Therapy and Digital Music Rehabilitation in Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Change from baseline in the MoCA score at 3-month stage
研究概览
简要总结
This study evaluates the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in home and care home settings.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Prior severe psychiatric illness or substance abuse
- •Major hearing or visual impairment
结局指标
主要结局
Change from baseline in the MoCA score at 3-month stage
时间窗: 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
时间窗: 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
次要结局
- 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 Naming score at 3-month and 6-month stages(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(Baseline, 3-month stage 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 CERAD Word List Recall score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the NPI-Q Severity score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the MoCA score at 6-month stage(Baseline and 6-month stage)
- 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)
- 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)
- Change from baseline in the MADRS score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the PROMIS Depression score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the UWES-9 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 WMS-IV Logical Memory II score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in autobiographical memory score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the NPI-Q Distress score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the caregiver ZBI-12 score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the CERAD Constructional Praxis score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the IFS total score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the IFS Working memory subscore at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the NPI-Q total score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the QoL-AD score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- 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)
- Change from baseline in the caregiver GHQ-12 score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the IFS Executive subscore at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the PROMIS Anxiety score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- Change from baseline in the PCTB score at 3-month and 6-month stages(Baseline, 3-month stage and 6-month stage)
- 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)
研究者
Teppo Sarkamo
Associate Professor
University of Helsinki