Music Interventions for Dementia and Depression in Elderly Care

NCT03496675 | Completed DMC

• 1 other identifier: MIDDEL
• Study Type: interventional
• Target: 1,021
• Locations: 6 countries
• Sites: 6

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.

Conditions

Dementia; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  up to 24 months

• Clinical Dementia Rating (CDR)

  12 months

• Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity

  12 months

• Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress

  12 months

• EuroQol (EQ-5D)

  12 months

Study Arms (4)

Standard care

OTHER

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

Other: Standard care

Group Music Therapy (GMT)

EXPERIMENTAL

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).

Behavioral: Group Music Therapy; Other: Standard care

Recreational Choir Singing (RCS)

EXPERIMENTAL

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).

Behavioral: Recreational Choir Singing; Other: Standard care

GMT + RCS

EXPERIMENTAL

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.

Behavioral: Group Music Therapy; Behavioral: Recreational Choir Singing; Other: Standard care

Interventions

Group Music Therapy BEHAVIORAL

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.

GMT + RCS; Group Music Therapy (GMT)

Recreational Choir Singing BEHAVIORAL

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.

GMT + RCS; Recreational Choir Singing (RCS)

Standard care OTHER

May include pharmacological and non-pharmacological interventions as locally available

GMT + RCS; Group Music Therapy (GMT); Recreational Choir Singing (RCS); Standard care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• NORCE Norwegian Research Centre AS: lead
• University of Melbourne: collaborator
• University of Oldenburg: collaborator
• University Medical Center Groningen: collaborator
• Ankara Haci Bayram Veli University: collaborator
• University of Nottingham: collaborator

Study Sites (6)

The University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Carl von Ossietzky University Oldenburg

Oldenburg, 26111, Germany

Location

University Medical Centre Groningen

Groningen, 9713 AV, Netherlands

Location

NORCE Norwegian Research Centre

Bergen, Vestland, 5838, Norway

Location

Ankara Hacı Bayram Veli University

Ankara, 06570, Turkey (Türkiye)

Location

University of Nottingham

Nottingham, NG7 2RD, United Kingdom

Location

Related Publications (11)

• 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.

  BACKGROUND

• 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.

  PMID: 30721998 BACKGROUND

• 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.

  PMID: 36098290 BACKGROUND

• 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.

  PMID: 33305065 BACKGROUND

• 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.

  PMID: 30928926 BACKGROUND

• 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.

  PMID: 35801957 BACKGROUND

• 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.

  PMID: 35448016 BACKGROUND

• Schneider J, Ablewhite J, Bloska J, Orrell M, Odell-Miller H, Assmus J, Gold C, Sveinsdottir V. Impact of Music Interventions on Depression in Care Home Residents with Dementia: UK Results from Music Interventions for Depression and Dementia in Elderly Care RCT. Geriatrics (Basel). 2025 Dec 15;10(6):166. doi: 10.3390/geriatrics10060166.

  PMID: 41440736 DERIVED

• Sveinsdottir V, Assmus J, Schneider J, Baker FA, Ucaner B, Kreutz G, Geretsegger M, Rasing N, Bloska J, Stretton-Smith PA, Lee YC, Wake JD, Odell-Miller H, Tamplin J, Vink AC, Ablewhite J, Neuser J, Frischen U, Timmer A, Wosch T, Janus S, Gold C. Clinical effectiveness of music interventions for dementia and depression in older people (MIDDEL): a multinational, cluster-randomised controlled trial. Lancet Healthy Longev. 2025 Dec;6(12):100783. doi: 10.1016/j.lanhl.2025.100783. Epub 2025 Dec 8.

  PMID: 41380710 DERIVED

• Rasing NL, Janus SIM, Vink AC, Frischen UAS, Neuser J, Wake JD, Skoluda N, Sveinsdottir V, Geretsegger M, Langeland E, Kreutz G, Gold C, Nater UM, Zuidema SU. The short-term impact of music interventions on stress: Results of a multinational cluster-randomized trial using salivary cortisol and alpha-amylase assessments in care home residents with dementia. Psychoneuroendocrinology. 2025 Dec;182:107640. doi: 10.1016/j.psyneuen.2025.107640. Epub 2025 Oct 2.

  PMID: 41072366 DERIVED

• Rasing NL, Vink AC, Bloska J, Nevruz H, Bakirci T, Saltik Y, Ucaner B, Dugstad Wake J, Sveinsdottir V, Geretsegger M, Gold C, Frischen U, Neuser J, Kreutz G, Zuidema SU, Janus SIM. Video Analysis of Group Music Therapy for Dementia: Intervention Delivery and Treatment Fidelity. J Music Ther. 2025 Jan 10;62(1):thaf007. doi: 10.1093/jmt/thaf007.

  PMID: 40616479 DERIVED

Related Links

• Project website

MeSH Terms

Conditions

Dementia; Depression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Vigdis Sveinsdottir, PhD

  GAMUT, NORCE Norwegian Research Centre, Bergen, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: April 12, 2018
• Study Start: July 18, 2018
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available upon publication of the primary outcome.
• 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).

Locations

TU (1); GB (1); DE (1); NL (1); AU (1); NO (1)