search
Back to results

Music Interventions for Dementia and Depression in Elderly Care (MIDDEL)

Primary Purpose

Dementia, Depression

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Group Music Therapy
Recreational Choir Singing
Standard care
Sponsored by
NORCE Norwegian Research Centre AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • resident (full-time, 24h/day) at a participating care home;
  • dementia as indicated by a Clinical Dementia Rating score of 0.5 or more and a Mini-Mental State Examination (MMSE) score of 26 or less;
  • at least mild depressive symptoms, as indicated by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 8;
  • a clinical diagnosis of dementia according to ICD-10 research criteria;
  • have given written informed consent (may be assent by proxy for those unable to provide consent themselves).

Exclusion Criteria:

  • diagnosis of schizophrenia or Parkinson's disease;
  • severe hearing-impairment;
  • in short-term care;
  • unable to tolerate sitting in a chair for the duration of the sessions.

Sites / Locations

  • The University of Melbourne
  • Carl von Ossietzky University OldenburgRecruiting
  • University Medical Centre GroningenRecruiting
  • NORCE Norwegian Research CentreRecruiting
  • Ankara Hacı Bayram Veli UniversityRecruiting
  • University of NottinghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

Standard care

Group Music Therapy (GMT)

Recreational Choir Singing (RCS)

GMT + RCS

Arm Description

Participants receive standard care as locally available. The components of standard care are recorded.

GMT is provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each. In line with usual practice, and as appropriate in local contexts, residents of a unit allocated to GMT may be divided into smaller groups (e.g. around 5 participants).

RCS is provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each. RCS may be conducted in larger groups (e.g. with all residents of the unit in one group).

Group Music Therapy and Recreational Choir Singing are both provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each.

Outcomes

Primary Outcome Measures

Montgomery-Åsberg Depression Rating Scale (MADRS)
10-item scale where each item is rated from 0 to 6 ('no abnormality' to 'severe'), yielding a total sum score between 0 and 60, with higher values indicating more severe symptom levels.

Secondary Outcome Measures

Montgomery-Åsberg Depression Rating Scale (MADRS)
10-item scale where each item is rated from 0 to 6 ('no abnormality' to 'severe'), yielding a total sum score between 0 and 60, with higher values indicating more severe symptom levels.
Clinical Dementia Rating (CDR)
Semi-structured interview with the person living with dementia and an appropriate caregiver/relative; rates impairment across 6 cognitive categories (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care). The CDR score can range from 0 (normal) to 3 (severe dementia); not used at all sites.
Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity
Includes 12 domains where if a symptom is present, its severity (from 1 = mild to 3 = severe) is assessed by a caregiver familiar with the participant's behaviour. Higher scores (sums of all items, range 0 to 36) represent higher severity.
Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress
Includes 12 domains where if a symptom is present, the associated distress on caregivers (from 0 = not distressing at all to 5 = extreme or very severe) is assessed by a caregiver familiar with the participant's behaviour. Higher scores (sums of all items, range 0 to 60) represent higher severity.
EuroQol (EQ-5D)
Standardized, non-disease-specific instrument for evaluating health-related quality of life, defining health in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Response categories range from "no problems" to "extreme problems". Scores are derived using a weighted scoring method and can range from 0 = worst possible to 1 = best possible quality of life.
Quality of Life in Alzheimer´s Dementia (QOL-AD)
13-item scale with self-rating and proxy version. Each item ranges from 1 (poor) to 4 (excellent), yielding a total sum score of 13 to 52.
All-cause mortality (time to death)
Data on participant deaths will be collected from care staff on a monthly basis.
Any increase in medication use (binary, yes/no)
Data on type (ATC Codes N065, N06) of medication used and any increase or decrease over time will be collected from care staff using the 'medication profile' section of a tailored version of the Client Socio-Demographic and Service Receipt Inventory (CSSRI), or from available databases.
Costs
Total and component costs of the interventions are assessed from a societal perspective, including the cost of the intervention as well as statutory health and social care services used, using a tailored version of the Client Socio-Demographic and Service Receipt Inventory (CSSRI). Total cost per participant will be calculated in Euros.
Any adverse event [Safety]
All types of adverse events and serious adverse events (e.g. unexpected worsening of symptoms), whether related or unrelated to the interventions, are reported.
Professional Care Team Burden Scale
10-item scale to obtain ratings of burden from formal care teams working in care homes. Items are scored on a 5-point scale from 0 (strongly disagree) to 4 (strongly agree), yielding a total sum score from 0 to 40, with higher scores indicating higher burden.
Days on sick leave of care staff
(as recorded monthly by the employer)

Full Information

First Posted
March 6, 2018
Last Updated
November 22, 2022
Sponsor
NORCE Norwegian Research Centre AS
Collaborators
University of Melbourne, University of Oldenburg, University Medical Center Groningen, Ankara Haci Bayram Veli University, University of Nottingham
search

1. Study Identification

Unique Protocol Identification Number
NCT03496675
Brief Title
Music Interventions for Dementia and Depression in Elderly Care
Acronym
MIDDEL
Official Title
Music Interventions for Dementia and Depression in Elderly Care: International Cluster-randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS
Collaborators
University of Melbourne, University of Oldenburg, University Medical Center Groningen, Ankara Haci Bayram Veli University, University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the effectiveness of two music-based approaches - group music therapy and recreational choir singing - for reducing depression symptoms in people living with dementia. It also examines mechanisms and heterogeneity of treatment effects.
Detailed Description
Dementia and depression are highly prevalent and comorbid conditions in older adults and are associated with individual distress, substantial carer burden, and high societal costs. Music interventions represent a highly promising type of non-pharmacological interventions for both dementia and depression in older adults. They are widely used, but have yet to be rigorously tested in large trials. The MIDDEL trial is the largest trial of music interventions to date, and the first to compare different music-based interventions - group music therapy (GMT), and recreational choir singing (RCS) - alone and in combination across countries. MIDDEL is designed as a large, pragmatic, international cluster-randomised controlled trial with a 2x2 factorial design that will compare the effects of GMT, RCS, both, or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. Study sites will be located in Australia and in five European countries, and a total of 100 care home units will be randomised to one of the four study conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Masking Description
Blinding of assessors will be ensured by using assessors who do not participate in the daily care of each unit. Assessors will also remind participants not to reveal the unit's allocation to them. At the time of the last assessment, success of blinding will be verified by asking assessors whether they inadvertently discovered the unit's allocation. Intervention providers and study participants (PLWD and staff) cannot be blinded due to the nature of the interventions. However, efforts will be made to ensure that no differential expectations are created and equipoise is maintained (e.g., by careful wording of the patient information and consent form).
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Other
Arm Description
Participants receive standard care as locally available. The components of standard care are recorded.
Arm Title
Group Music Therapy (GMT)
Arm Type
Experimental
Arm Description
GMT is provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each. In line with usual practice, and as appropriate in local contexts, residents of a unit allocated to GMT may be divided into smaller groups (e.g. around 5 participants).
Arm Title
Recreational Choir Singing (RCS)
Arm Type
Experimental
Arm Description
RCS is provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each. RCS may be conducted in larger groups (e.g. with all residents of the unit in one group).
Arm Title
GMT + RCS
Arm Type
Experimental
Arm Description
Group Music Therapy and Recreational Choir Singing are both provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each.
Intervention Type
Behavioral
Intervention Name(s)
Group Music Therapy
Intervention Description
The core intention of GMT is to meet the psychosocial needs of each person living with dementia, which in turn is thought to reduce depressive symptoms and anxiety and to stimulate overall social and emotional wellbeing. It includes active, reciprocal music making with the use of singing and musical instruments. GMT is provided by a trained music therapist, highly skilled as a musician, and registered with the appropriate professional association in his or her country.
Intervention Type
Behavioral
Intervention Name(s)
Recreational Choir Singing
Intervention Description
RCS is intended to foster connectedness in a group, wellbeing, and enjoyment of music making in a group. It includes singing familiar songs and providing a familiar musical environment for participants. RCS is provided by a musician with choir leading skills.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
May include pharmacological and non-pharmacological interventions as locally available
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
10-item scale where each item is rated from 0 to 6 ('no abnormality' to 'severe'), yielding a total sum score between 0 and 60, with higher values indicating more severe symptom levels.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
10-item scale where each item is rated from 0 to 6 ('no abnormality' to 'severe'), yielding a total sum score between 0 and 60, with higher values indicating more severe symptom levels.
Time Frame
up to 24 months
Title
Clinical Dementia Rating (CDR)
Description
Semi-structured interview with the person living with dementia and an appropriate caregiver/relative; rates impairment across 6 cognitive categories (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care). The CDR score can range from 0 (normal) to 3 (severe dementia); not used at all sites.
Time Frame
12 months
Title
Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity
Description
Includes 12 domains where if a symptom is present, its severity (from 1 = mild to 3 = severe) is assessed by a caregiver familiar with the participant's behaviour. Higher scores (sums of all items, range 0 to 36) represent higher severity.
Time Frame
12 months
Title
Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress
Description
Includes 12 domains where if a symptom is present, the associated distress on caregivers (from 0 = not distressing at all to 5 = extreme or very severe) is assessed by a caregiver familiar with the participant's behaviour. Higher scores (sums of all items, range 0 to 60) represent higher severity.
Time Frame
12 months
Title
EuroQol (EQ-5D)
Description
Standardized, non-disease-specific instrument for evaluating health-related quality of life, defining health in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Response categories range from "no problems" to "extreme problems". Scores are derived using a weighted scoring method and can range from 0 = worst possible to 1 = best possible quality of life.
Time Frame
12 months
Title
Quality of Life in Alzheimer´s Dementia (QOL-AD)
Description
13-item scale with self-rating and proxy version. Each item ranges from 1 (poor) to 4 (excellent), yielding a total sum score of 13 to 52.
Time Frame
12 months
Title
All-cause mortality (time to death)
Description
Data on participant deaths will be collected from care staff on a monthly basis.
Time Frame
up 24 months
Title
Any increase in medication use (binary, yes/no)
Description
Data on type (ATC Codes N065, N06) of medication used and any increase or decrease over time will be collected from care staff using the 'medication profile' section of a tailored version of the Client Socio-Demographic and Service Receipt Inventory (CSSRI), or from available databases.
Time Frame
12 months
Title
Costs
Description
Total and component costs of the interventions are assessed from a societal perspective, including the cost of the intervention as well as statutory health and social care services used, using a tailored version of the Client Socio-Demographic and Service Receipt Inventory (CSSRI). Total cost per participant will be calculated in Euros.
Time Frame
12 months
Title
Any adverse event [Safety]
Description
All types of adverse events and serious adverse events (e.g. unexpected worsening of symptoms), whether related or unrelated to the interventions, are reported.
Time Frame
12 months
Title
Professional Care Team Burden Scale
Description
10-item scale to obtain ratings of burden from formal care teams working in care homes. Items are scored on a 5-point scale from 0 (strongly disagree) to 4 (strongly agree), yielding a total sum score from 0 to 40, with higher scores indicating higher burden.
Time Frame
12 months
Title
Days on sick leave of care staff
Description
(as recorded monthly by the employer)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: resident (full-time, 24h/day) at a participating care home; dementia as indicated by a Clinical Dementia Rating score of 0.5 or more and a Mini-Mental State Examination (MMSE) score of 26 or less; at least mild depressive symptoms, as indicated by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 8; a clinical diagnosis of dementia according to ICD-10 research criteria; have given written informed consent (may be assent by proxy for those unable to provide consent themselves). Exclusion Criteria: diagnosis of schizophrenia or Parkinson's disease; severe hearing-impairment; in short-term care; unable to tolerate sitting in a chair for the duration of the sessions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vigdis Sveinsdottir, PhD
Phone
(+47) 56107287
Email
visv@norceresearch.no
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Gold, PhD
Phone
(+47) 46928297
Email
chgo@norceresearch.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vigdis Sveinsdottir, PhD
Organizational Affiliation
GAMUT, NORCE Norwegian Research Centre, Bergen, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia
Individual Site Status
Completed
Facility Name
Carl von Ossietzky University Oldenburg
City
Oldenburg
ZIP/Postal Code
26111
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunter Kreutz, Prof.
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9713 AV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sytse U. Zuidema, Prof.
Facility Name
NORCE Norwegian Research Centre
City
Bergen
State/Province
Vestland
ZIP/Postal Code
5838
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vigdis Sveinsdottir, PhD
Facility Name
Ankara Hacı Bayram Veli University
City
Ankara
ZIP/Postal Code
06570
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burçin Uçaner Çifdalöz, PhD
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2RD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine Schneider, Prof.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified datasets (participant codes and outcome scores) generated during and/or analysed during the current study will be stored in a publically available repository (NSD - Norwegian Centre for Research Data, http://www.nsd.uib.no/nsd/english/index.html).
IPD Sharing Time Frame
Data will become available upon publication of the primary outcome.
IPD Sharing Access Criteria
De-identified IPD will be publicly available at the Norwegian Centre for Research Data (http://www.nsd.uib.no/nsd/english/index.html).
Citations:
Citation
Janus, S. I. M., Vink, A. C., Ridder, H. M., Geretsegger, M., Stige, B., Gold, C., & Zuidema, S. U. (2020). Developing consensus description of group music therapy characteristics for persons with dementia. Nordic Journal of Music Therapy, 1-17.
Results Reference
result
PubMed Identifier
30721998
Citation
Baker FA, Tamplin J, Clark IN, Lee YC, Geretsegger M, Gold C. Treatment Fidelity in a Music Therapy Multi-site Cluster Randomized Controlled Trial for People Living With Dementia: The MIDDEL Project Intervention Fidelity Protocol. J Music Ther. 2019 May 10;56(2):125-148. doi: 10.1093/jmt/thy023.
Results Reference
result
PubMed Identifier
36098290
Citation
Baker FA, Lee YC, Sousa TV, Stretton-Smith PA, Tamplin J, Sveinsdottir V, Geretsegger M, Wake JD, Assmus J, Gold C. Clinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international pragmatic cluster-randomised controlled trial. Lancet Healthy Longev. 2022 Mar;3(3):e153-e165. doi: 10.1016/S2666-7568(22)00027-7. Erratum In: Lancet Healthy Longev. 2022 Oct;3(10):e653.
Results Reference
derived
PubMed Identifier
35448016
Citation
Rasing NL, Janus SIM, Kreutz G, Sveinsdottir V, Gold C, Nater UM, Zuidema SU. The Impact of Music on Stress Biomarkers: Protocol of a Substudy of the Cluster-Randomized Controlled Trial Music Interventions for Dementia and Depression in ELderly Care (MIDDEL). Brain Sci. 2022 Apr 8;12(4):485. doi: 10.3390/brainsci12040485.
Results Reference
derived
PubMed Identifier
30928926
Citation
Gold C, Eickholt J, Assmus J, Stige B, Wake JD, Baker FA, Tamplin J, Clark I, Lee YC, Jacobsen SL, Ridder HMO, Kreutz G, Muthesius D, Wosch T, Ceccato E, Raglio A, Ruggeri M, Vink A, Zuidema S, Odell-Miller H, Orrell M, Schneider J, Kubiak C, Romeo R, Geretsegger M. Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial. BMJ Open. 2019 Mar 30;9(3):e023436. doi: 10.1136/bmjopen-2018-023436.
Results Reference
derived
Links:
URL
http://middel-project.eu
Description
Project website

Learn more about this trial

Music Interventions for Dementia and Depression in Elderly Care

We'll reach out to this number within 24 hrs