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

Music Interventions for Dementia and Depression in Elderly Care: International Cluster-randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Depression; Dementia
• Intervention / Treatment: Other: Standard care; Behavioral: Group Music Therapy; Behavioral: Recreational Choir Singing

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.

• Study Type: Interventional
• Enrollment (Actual): 1021
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3010
      • The University of Melbourne
• Germany
  • Oldenburg, Germany, 26111
    • Carl von Ossietzky University Oldenburg
• Netherlands
  • Groningen, Netherlands, 9713 AV
    • University Medical Centre Groningen
• Norway
  • Vestland
    • Bergen, Vestland, Norway, 5838
      • NORCE Norwegian Research Centre
• Turkey
  • Ankara, Turkey, 06570
    • Ankara Hacı Bayram Veli University
• United Kingdom
  • Nottingham, United Kingdom, NG7 2RD
    • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard care; Participants receive standard care as locally available. The components of standard care are recorded.	Other: Standard care; May include pharmacological and non-pharmacological interventions as locally available
Experimental: Group Music Therapy (GMT); 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).	Other: Standard care; May include pharmacological and non-pharmacological interventions as locally available; Behavioral: Group Music Therapy; 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.
Experimental: Recreational Choir Singing (RCS); 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).	Other: Standard care; May include pharmacological and non-pharmacological interventions as locally available; Behavioral: Recreational Choir Singing; 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.
Experimental: GMT + RCS; 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.	Other: Standard care; May include pharmacological and non-pharmacological interventions as locally available; Behavioral: Group Music Therapy; 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.; Behavioral: Recreational Choir Singing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 24 months
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.	12 months
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.	12 months
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.	12 months
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.	12 months
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.	12 months
All-cause mortality (time to death)	Data on participant deaths will be collected from care staff on a monthly basis.	up 24 months
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.	12 months
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.	12 months
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.	12 months
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.	12 months
Days on sick leave of care staff	(as recorded monthly by the employer)	12 months

Collaborators and Investigators

• Sponsor: NORCE Norwegian Research Centre AS
• Collaborators: University of Nottingham; University Medical Center Groningen; University of Melbourne; University of Oldenburg; Ankara Haci Bayram Veli University
• Investigators: Principal Investigator: Vigdis Sveinsdottir, PhD, GAMUT, NORCE Norwegian Research Centre, Bergen, Norway

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Baker FA, Stretton-Smith PA, Sousa TV, Clark I, Cotton A, Gold C, Lee YC. Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team. Contemp Clin Trials Commun. 2020 Nov 25;20:100675. doi: 10.1016/j.conctc.2020.100675. eCollection 2020 Dec.
• Lee YC, Sousa TV, Stretton-Smith PA, Gold C, Geretsegger M, Baker FA. Demographic and clinical profile of residents living with dementia and depressive symptoms in Australian private residential aged care: Data from the Music Interventions for Dementia and Depression in ELderly care (MIDDEL) cluster-randomised controlled trial. Australas J Ageing. 2022 Dec;41(4):e387-e396. doi: 10.1111/ajag.13104. Epub 2022 Jul 8.

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Mood Disorders; Depression; Depressive Disorder; Dementia
• Other Study ID Numbers: MIDDEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Study Data/Documents

1. Individual Participant Data Set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No