Tailored Music Therapy for Dementia

NCT03011723 | Completed

• 1 other identifier: UBergen 2016/1374
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect and process of individualized music therapy for home-dwelling persons with mild to moderate dementia. The music therapy is administered individually and includes a close caregiver. Memory of familiar music is found to be retained in persons with dementia. It is assumed to facilitate autobiographical memories and stimulate interaction with significant others. Based on time series analyses we will use statistical process control to evaluate when and how change occur.

Conditions

Alzheimer Dementia; Dementia, Vascular; Dementia, Lewy Body; Dementia Parkinson's Disease

Outcome Measures

Primary Outcomes (3)

• Change in social interaction behavior throughout the music therapy session compared to baseline(Verbal and Nonverbal Interaction Scale (VNVIS))

  Verbal and nonverbal interaction scale(VNVIS) is a standardized observational instrument for assessing prosocial and nonsocial verbal and nonverbal communication behavior between a person with dementia and their close caregiver. The scale is measuring both prosocial and nonsocial behavior, 26 items, 13 pr subscale. The person can score from 0-13 points on prosocial items pr timepoint, higher score indicates more prosocial behavior is present. The same holds for nonsocial behavior, the higher score indicates more nonsocial behavior observed.

  Baseline (the first 5 videorecorded minutes before the music therapy) up to 45 minutes with music therapy intervention. The 1st, 5th and 10th session is videorecorded. Observation-interval is 30 seconds.

• Observable signs of well being (OSWDS)

  The observable signs of wellbeing in dementia- scale (OSWDS) is a scale for proxy-rated well being in persons with dementia. The scale is under development, and is tested during the intervention. It consists of 10 items measuring from 0-10 points. Each item is rated as present or non-present during the time interval. Higher score indicates higher levels of observed wellbeing.

  Baseline (the first 5 videorecorded minutes before the music therapy) up to 45 minutes with music therapy intervention. The 1st, 5th and 10th session is videorecorded. Observation-interval is 30 seconds.

• Change in self reported mood before and after the music therapy session (Visual Analogue Mood Scale (VAMS))

  VAMS is a standardized visual analogue scale tailored to persons with cognitive impairment measuring 8 self reported mood states. Each state is scored by marking on a 10 cm line by the person with dementia. The score is calculated by measuring the point on the line in mm, and the range is 0-100, were 100 indicates maximum emotional experience.

  Assessment before and after every music therapy session (10 weeks) and before and after every musical activity with the relative (10 weeks)

Secondary Outcomes (4)

• Change in Neuropsychiatric symptoms (NPI-Q)

  Baseline and post-treatment (up to two weeks after the intervention period)

• Change in Quality of life in Alzheimer Dementia (QoL-AD)

  Baseline and post-treatment (up to two weeks after the intervention period)

• Change in Relative Stress Scale (RSS)

  Baseline and post-treatment (up to two weeks after the intervention period)

• Change in Music in Dementia Assessment Scales (MiDAS)

  Before and after every music therapy session (10 weeks)

Other Outcomes (1)

• Mini Mental Status Examination (MMSE)

  Baseline

Study Arms (1)

Music therapy

EXPERIMENTAL

10 weekly sessions of in-home music therapy for PWDs and a caregiver, including weekly practicing of the interventions with the caregiver between the sessions. The treatment is administered individually.

Behavioral: Resource oriented music therapy

Interventions

Resource oriented music therapy BEHAVIORAL

10 weeks of tailored individual music therapy for PWD and a caregiver. Pre and post assessment in addition. The music therapy consists of one or more of the following activities: 1. Singing 2. Listening to live music 3. Listening to recorded music 4. Dancing 5. Conversations about memories/reminiscence 6. Exercising to music 7. Breathing exercises and relaxing exercises The treatment is following the principles of resource oriented music therapy as described by Rolvsjord et al (2005)

Music therapy

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is diagnosed with Dementia of the Alzheimer's type, Vascular Dementia, Dementia with Lewy bodies, Parkinsons's Disease Dementia (ICD-10 criteria)
• The severity of the cognitive impairment is within the range of 0,5 - 2 when assessed with The Clinical Dementia Rating Scale (CDR)
• A caregiver chosen by the patient commits to involvement in the treatment as a collateral (i.e. spouse, child, grandchild, sibling, close friend)
• Use of psychotropic medication has been stable during the past 2 weeks
• The PWD is able to answer simple self-report questionnaires on their own or when interviewed by a trained professional
• Informed consent is obtained from patients and caregiver
• The PWD's are living in their home, in assisted living facilities or only periodical living in care homes.

You may not qualify if:

• Severe dementia(a score of 3\> on CDR).
• Severe aphasia
• Frontotemporal dementia
• Comorbid diagnosis of bipolar disorder, diagnosis of schizophrenia and related disorders
• Changes in psychotropic medications in the past 2 weeks. If so, the medication needs to be stable before pre-assessment is undertaken
• Severe psychotic symptoms or serious risk of suicide
• Permanent living arrangement in nursing home, or planned temporary stay during the treatment period

Sponsors & Collaborators

• University of Bergen: lead
• NKS Olaviken Alderspsykiatriske sykehus: collaborator

Study Sites (1)

NKS Olaviken Alderspsykiatriske sykehus

Bergen, 5009, Norway

Location

Related Publications (3)

• Shall A, Haberstroh J, Pantel J. Time series analysis of individual music therapy in dementia. Effects on communication behavior and emotional well-being. Gero Psych 28 (3): 113-122, 2015

  BACKGROUND

• Baker FA, Grocke D, Pachana NA, Clair AA. Connecting through music: a study of a spousal caregiver-directed music intervention designed to prolong fulfilling relationships in couples where one person has dementia. Australian Journal of Music Therapy, 23: 4-21, 2012.

  BACKGROUND

• Rolvsjord R, Gold C, Stige B. Research rigour and therapeutic flexibility: Rationale for a therapy manual developed for a randomised controlled trial. Nordic Journal of Music Therapy 14(1), 15-32, 2005.

  BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia, Vascular; Lewy Body Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Inger Hilde Nordhus, Professor, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: January 5, 2017
• Study Start: January 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 4, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)