Tailored Music Therapy for Dementia

NCT ID: NCT03011723

Last Updated: 2020-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-12-31

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.)

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Resource oriented music therapy

Intervention Type: BEHAVIORAL

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)

Interventions

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)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NKS Olaviken Alderspsykiatriske sykehus

UNKNOWN

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inger Hilde Nordhus, Professor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

NKS Olaviken Alderspsykiatriske sykehus

Bergen, , Norway

Countries

Norway

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Other Identifiers

UBergen 2016/1374

Identifier Type: -

Identifier Source: org_study_id