Tailored Music Therapy for Dementia

Dementia, Vascular Clinical Trial

Official title:

Positive Emotions, Communication and Quality of Life in Dementia: A Tailored Music Therapy Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011723
• Other study ID #: UBergen 2016/1374
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Dementia is often followed by complicating symptoms such as anxiety, depression, agitation, hallucination and sleep disorders. The progression of dementia can threaten the relationship between the person with dementia (PWD) and their relatives. One reason is the possible loss of reciprocity and a mutual supportive relationship. This may influence the quality of life in both the PWD and their relatives and increase the caregiver-burden. The music therapy in this intervention is focusing on increasing positive emotions, increasing reciprocity and stimulating communication. The 1st, 5th and 10th music therapy-session is video-recorded. The first 5 recorded minutes before the sessions will provide a baseline of the observed primary outcomes throughout the session. Videos are analyzed to examine changes in social communication behavior and emotional well-being. Time-series analysis of the observations will be conducted, enabling us to evaluate potential effects of the therapeutic interventions and to find out when, why and to what extent changes unfold in real time. The pre-post measures are secondary. The project is a merging and further development of two recent music therapy designs. (Articles cited in the references.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Resource oriented music therapy
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: Singing Listening to live music Listening to recorded music Dancing Conversations about memories/reminiscence Exercising to music Breathing exercises and relaxing exercises The treatment is following the principles of resource oriented music therapy as described by Rolvsjord et al (2005)

Locations

Country	Name	City	State
Norway	NKS Olaviken Alderspsykiatriske sykehus	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	NKS Olaviken Alderspsykiatriske sykehus

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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.

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.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mini Mental Status Examination (MMSE)	Screening instrument for cognitive impairment. The scale consists of 30 questions and tasks. The range is 0-30 points, were a higher score indicates higher cognitive functions.	Baseline
Primary	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.
Primary	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.
Primary	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	Change in Neuropsychiatric symptoms (NPI-Q)	NPI-Q is a standardized measure of common neuropsychiatric symptoms following dementia. The scale consists of 12 items rated from 0-3. Items are summed, and the range is 0-36. Higher score means more severe neuropsychiatric symptoms.	Baseline and post-treatment (up to two weeks after the intervention period)
Secondary	Change in Quality of life in Alzheimer Dementia (QoL-AD)	QoL-AD is a standardized interview designed to measure items concerning the experienced quality of life in persons with dementia. The scale consists of 15 items from 1-4. The items are summed, and the range is 15-60. Higher score means higher self-reported quality of life.	Baseline and post-treatment (up to two weeks after the intervention period)
Secondary	Change in Relative Stress Scale (RSS)	RSS is a standardized measure of self-reported caregiver burden in carers of PWD. 15 items are scored from 0-4, giving a range from 0-60. A higher score indicates more severe stress for the caregiver.	Baseline and post-treatment (up to two weeks after the intervention period)
Secondary	Change in Music in Dementia Assessment Scales (MiDAS)	MiDAS is a standardized music therapy outcome scale measuring clinical response to the intervention. The scale consists of 5 items on a visual analogue scale, and the music therapist score the items for the 5 first minutes and for the 5 most significant minutes in the session. Each item has a range from 0-100, were a higher score means a higher level of involvement in the music therapy. The 5 items are reviewed separately.	Before and after every music therapy session (10 weeks)