NCT03496675: MIDDEL

Music Interventions for Dementia and Depression in Elderly Care

Completed NA Last updated 9 July 2025

What this trial tests

NA trial testing Group Music Therapy in Dementia in 1,021 participants. Completed in 29 September 2023.

Timeline

18 July 2018

Primary endpoint
29 September 2023

29 September 2023

Quick facts

Lead sponsor	NORCE Norwegian Research Centre AS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	1,021
Start date	18 July 2018
Primary completion	29 September 2023
Estimated completion	29 September 2023
Sites	6 locations across Netherlands, United Kingdom, Germany, Norway, Australia, Turkey (Türkiye)

Drugs / interventions tested

• Group Music Therapy
• Recreational Choir Singing
• Standard care — full drug profile →

Conditions studied

• Dementia — all drugs for Dementia →
• Depression — all drugs for Depression →

Sponsor

NORCE Norwegian Research Centre AS

Who can join

65 and older, any sex, with Dementia or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Music Therapy in the Treatment of Dementia: A Systematic Review and Meta-Analysis.
   Moreno-Morales C, Calero R, Moreno-Morales P, Pintado C. · · 2020 · cited 100× · PMID 32509790 · DOI 10.3389/fmed.2020.00160
2. Clinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international pragmatic cluster-randomised controlled trial.
   Baker FA, Lee YC, Sousa TV, Stretton-Smith PA, et al · · 2022 · cited 44× · PMID 36098290 · DOI 10.1016/s2666-7568(22)00027-7
3. Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial.
   Gold C, Eickholt J, Assmus J, Stige B, et al · · 2019 · cited 25× · PMID 30928926 · DOI 10.1136/bmjopen-2018-023436
4. Music-based therapeutic interventions for people with dementia.
   van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, et al · · 2025 · cited 11× · PMID 40049590 · DOI 10.1002/14651858.cd003477.pub5
5. 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).
   Rasing NL, Janus SIM, Kreutz G, Sveinsdottir V, et al · · 2022 · cited 6× · PMID 35448016 · DOI 10.3390/brainsci12040485
6. Clinical effectiveness of music interventions for dementia and depression in older people (MIDDEL): a multinational, cluster-randomised controlled trial.
   Sveinsdottir V, Assmus J, Schneider J, Baker FA, et al · · 2025 · cited 4× · PMID 41380710 · DOI 10.1016/j.lanhl.2025.100783
7. 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.
   Schneider J, Ablewhite J, Bloska J, Orrell M, et al · · 2025 · cited 2× · PMID 41440736 · DOI 10.3390/geriatrics10060166
8. Video Analysis of Group Music Therapy for Dementia: Intervention Delivery and Treatment Fidelity.
   Rasing NL, Vink AC, Bloska J, Nevruz H, et al · · 2025 · cited 1× · PMID 40616479 · DOI 10.1093/jmt/thaf007