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Trial record 44 of 1046 for:    scale | Norway

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. Identifier: NCT03011723
Recruitment Status : Active, not recruiting
First Posted : January 5, 2017
Last Update Posted : September 27, 2019
NKS Olaviken Alderspsykiatriske sykehus
Information provided by (Responsible Party):
University of Bergen

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.

Condition or disease Intervention/treatment Phase
Alzheimer Dementia Dementia, Vascular Dementia, Lewy Body Dementia Parkinson's Disease Behavioral: Resource oriented music therapy Not Applicable

Detailed 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 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.)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
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:

  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)

Primary Outcome Measures :
  1. 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.

  2. Change in observed expression of affect throughout the music therapy session compared to baseline(Observable Displays of Affect Scale (ODAS)) [ 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. ]
    ODAS is a standardized observational instrument for assessing positive and negative emotional displays in PWD's.

  3. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other Outcome Measures:
  1. Mini Mental Status Examination (MMSE) [ Time Frame: Baseline ]
    Screening instrument for cognitive impairment

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03011723

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NKS Olaviken Alderspsykiatriske sykehus
Bergen, Norway, 5009
Sponsors and Collaborators
University of Bergen
NKS Olaviken Alderspsykiatriske sykehus
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Principal Investigator: Inger Hilde Nordhus, Professor, PhD University of Bergen

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
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.

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Responsible Party: University of Bergen Identifier: NCT03011723     History of Changes
Other Study ID Numbers: UBergen 2016/1374
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Dementia, Vascular
Lewy Body Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases