Tailored Music Therapy for Dementia
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|ClinicalTrials.gov Identifier: NCT03011723|
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : May 7, 2018
|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 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)|
|Estimated Enrollment :||20 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|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2021|
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 communication behavior throughout the music therapy session compared to baseline(Communication in Dementia (CODEM)) [ 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. ]CODEM is a standardized observational instrument for assessing communication behavior in dementia.
- Change in observed expression of emotion throughout the music therapy session compared to baseline(The Observed Emotion Rating Scale (OERS)) [ 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. ]OERS is a standardized observational instrument for assessing positive and negative emotional responses and states in PWD's.
- 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.
- 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.
- 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.
- 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.
- 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.
- Mini Mental Status Examination (MMSE) [ Time Frame: Baseline ]Screening instrument for cognitive impairment
- Cornell Scale of Depression [ Time Frame: Baseline ]Cornell is a standardized measure of depression in persons with cognitive impairment, as reported by the patient and a caregiver
- Rating Anxiety in Dementia - Structured Interview (RAID-SI) [ Time Frame: Baseline ]RAID-SI is a standardized measure of anxiety in persons with cognitive impairment, as reported by patient and a caregiver.
- Instrumental and personal activities of daily living (I-ADL & P-ADL) [ Time Frame: Baseline ]Measure of activities of daily living.
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
|Contact: Kristine G Madsoe, PsyD||55381880 ext +firstname.lastname@example.org|
|Contact: Minna Hynninen, PhD||56151000 ext +email@example.com|
|NKS Olaviken Alderspsykiatriske sykehus||Recruiting|
|Bergen, Norway, 5009|
|Principal Investigator:||Inger Hilde Nordhus, Professor, PhD||University of Bergen|