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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.
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.
Age
65 - No limit years
Sex
ALL
Healthy Volunteers
No
The University of Melbourne
Melbourne, Victoria, Australia
Carl von Ossietzky University Oldenburg
Oldenburg, Germany
University Medical Centre Groningen
Groningen, Netherlands
NORCE Norwegian Research Centre
Bergen, Vestland, Norway
Ankara Hacı Bayram Veli University
Ankara, Turkey (Türkiye)
University of Nottingham
Nottingham, United Kingdom
Start Date
July 18, 2018
Primary Completion Date
September 29, 2023
Completion Date
September 29, 2023
Last Updated
July 9, 2025
1,021
ACTUAL participants
Group Music Therapy
BEHAVIORAL
Recreational Choir Singing
BEHAVIORAL
Standard care
OTHER
Lead Sponsor
NORCE Norwegian Research Centre AS
Collaborators
NCT07360600
NCT06793397
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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