Clinical trial NCT03011723: Tailored Music Therapy for Dementia
Official title: Positive Emotions, Communication and Quality of Life in Dementia: A Tailored Music Therapy Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Dementia
Dementia, Vascular
Dementia, Lewy Body
Dementia Parkinson's Disease
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: NKS Olaviken Alderspsykiatriske sykehus
First posted: 2017-01-05
Enrollment: 11
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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.)

Eligibility criteria: 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

Primary outcomes:
measure: Change in social interaction behavior throughout the music therapy session compared to baseline(Verbal and Nonverbal Interaction Scale (VNVIS))
timeFrame: 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.
measure: Observable signs of well being (OSWDS)
timeFrame: 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.
measure: Change in self reported mood before and after the music therapy session (Visual Analogue Mood Scale (VAMS))
timeFrame: Assessment before and after every music therapy session (10 weeks) and before and after every musical activity with the relative (10 weeks)
Secondary outcomes:
measure: Change in Neuropsychiatric symptoms (NPI-Q)
timeFrame: Baseline and post-treatment (up to two weeks after the intervention period)
measure: Change in Quality of life in Alzheimer Dementia (QoL-AD)
timeFrame: Baseline and post-treatment (up to two weeks after the intervention period)
measure: Change in Relative Stress Scale (RSS)
timeFrame: Baseline and post-treatment (up to two weeks after the intervention period)
measure: Change in Music in Dementia Assessment Scales (MiDAS)
timeFrame: Before and after every music therapy session (10 weeks)
Other outcomes:
measure: Mini Mental Status Examination (MMSE)
timeFrame: Baseline
Locations:
city: Bergen
country: Norway
facility: NKS Olaviken Alderspsykiatriske sykehus
Study officials:
affiliation: University of Bergen
name: Inger Hilde Nordhus, Professor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.