Skip to main content

Research Repository

Advanced Search

Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial


Christian Gold

Jasmin Eickholt


Brynjulf Stige

Jo Dugstad Wake

Felicity Anne Baker

Jeanette Tamplin

Imogen Clark

Young-Eun Claire Lee

Stine Lindahl Jacobsen

Hanne Mette Ochsner Ridder

Gunter Kreutz

Dorothea Muthesius

Thomas Wosch

Enrico Ceccato

Alfredo Raglio

Mirella Ruggeri

Annemiek Vink

Sytse Zuidema

Helen Odell-Miller

Director - Institute of Mental Health

Professor of Mental Health & Social Care

Christine Kubiak

Renee Romeo

Monika Geretsegger


Introduction In older adults, dementia and depression are associated with individual distress and high societal costs. Music interventions such as group music therapy (GMT) and recreational choir singing (RCS) have shown promising effects, but their comparative effectiveness across clinical subgroups is unknown. This trial aims to determine effectiveness of GMT, RCS and their combination for care home residents and to examine heterogeneity of treatment effects across subgroups.

Methods and analysis This large, pragmatic, multinational cluster-randomised controlled trial with a 2×2 factorial design will compare the effects of GMT, RCS, both or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. We will randomise 100 care home units with ≥1000 residents in total across eight countries. Each intervention will be offered for 6 months (3 months 2 times/week followed by 3 months 1 time/week), with extension allowed if locally available. The primary outcome will be the change in the Montgomery-Åsberg Depression Rating Scale score at 6 months. Secondary outcomes will include depressive symptoms, cognitive functioning, neuropsychiatric symptoms, psychotropic drug use, caregiver burden, quality of life, mortality and costs over at least 12 months. The study has 90% power to detect main effects and is also powered to determine interaction effects with gender, severity and socioeconomic status.

Ethics and dissemination Ethical approval has been obtained for one country and will be obtained for all countries. Results will be presented at national and international conferences and published in scientific journals.


Gold, C., Eickholt, J., Assmus, J., Stige, B., Wake, J. D., Baker, F. A., …Geretsegger, M. (2019). Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial. BMJ Open, 9(3), Article e023436.

Journal Article Type Article
Acceptance Date Mar 15, 2019
Online Publication Date Mar 30, 2019
Publication Date 2019-03
Deposit Date Oct 22, 2021
Publicly Available Date Oct 22, 2021
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 9
Issue 3
Article Number e023436
Keywords General Medicine;Music; Residential Care
Public URL
Publisher URL


You might also like

Downloadable Citations