Tailored Music Therapy for Dementia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03011723|
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Dementia Dementia, Vascular Dementia, Lewy Body Dementia Parkinson's Disease||Behavioral: Resource oriented music therapy||Not Applicable|
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.)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Positive Emotions, Communication and Quality of Life in Dementia: A Tailored Music Therapy Intervention|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||November 2019|
|Actual Study Completion Date :||December 2019|
Experimental: Music therapy
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
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:
The treatment is following the principles of resource oriented music therapy as described by Rolvsjord et al (2005)
- Change in social interaction behavior throughout the music therapy session compared to baseline(Verbal and Nonverbal Interaction Scale (VNVIS)) [ Time Frame: 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. ]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.
- Observable signs of well being (OSWDS) [ Time Frame: 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. ]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.
- Change in self reported mood before and after the music therapy session (Visual Analogue Mood Scale (VAMS)) [ Time Frame: Assessment before and after every music therapy session (10 weeks) and before and after every musical activity with the relative (10 weeks) ]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.
- Change in Neuropsychiatric symptoms (NPI-Q) [ Time Frame: Baseline and post-treatment (up to two weeks after the intervention period) ]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.
- Change in Quality of life in Alzheimer Dementia (QoL-AD) [ Time Frame: Baseline and post-treatment (up to two weeks after the intervention period) ]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.
- Change in Relative Stress Scale (RSS) [ Time Frame: Baseline and post-treatment (up to two weeks after the intervention period) ]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.
- Change in Music in Dementia Assessment Scales (MiDAS) [ Time Frame: Before and after every music therapy session (10 weeks) ]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.
- Mini Mental Status Examination (MMSE) [ Time Frame: Baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011723
|NKS Olaviken Alderspsykiatriske sykehus|
|Bergen, Norway, 5009|
|Principal Investigator:||Inger Hilde Nordhus, Professor, PhD||University of Bergen|