Middel 4 heads

About the Project

Music interventions for people living with dementia

MIDDEL is a multinational pragmatic cluster-randomised trial to determine the effectiveness of two music interventions (group music therapy, recreational choir singing) for reducing depression symptoms in people living with dementia, and to examine mechanisms and heterogeneity of treatment effects.

Background

Dementia and depression are highly prevalent and comorbid conditions in older adults and are associated with individual distress, substantial burden for care providers, 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 two different approaches – 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 compares the effects of GMT, RCS, both, or neither, for care home residents aged 65 years or older with dementia and depressive symptoms.
Study sites are located in Australia and in five European countries, and a total of 100 care home units are to be randomised to one of the four study conditions.

PROJECT INFORMATION

Project period:
from November 2017 to April 2023

Trial registration
at ClinicalTrials.gov:
NCT03496675

at ANZTR: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000156280

Outcomes

Core outcome sets of depressive symptoms, cognitive functioning, neuropsychiatric symptoms, quality of life, medication use, caregiver burden and costs will be assessed at month 3, 6 and 12. The primary outcome will be the change in residents’ scores on the Montgomery-Åsberg Depression Rating Scale at 6 months. Cost-effectiveness will be assessed from a care sector and a societal perspective. The study is powered to detect main effects as well as interaction effects with dementia severity, gender, and socio-economic status.

As part of this study, internationally applicable guidelines based on an international consensus have been defined for both interventions. They will be further developed during the trial through process evaluation to improve both interventions.

>> Work packages

WP1: Trial methodology, randomisation, statistical analysis (led by NORCE)
WP2: GMT consensus; barriers and facilitators of GMT and RCS (led by UMCG)
WP3: RCS consensus (led by UOld)
WP4: Biomarkers (led by UMCG)
WP5: Public participation and involvement (led by UoN)
WP6: Coordination, governance, dissemination (led by NORCE)

MIDDEL AND THE CORONAVIRUS

From March 2020, most countries enforced radical measures to protect people, especially older adults, from infection with the new coronavirus. Choir singing seems to be especially risky, and dementia may be an additional risk factor, in addition to high age.

The MIDDEL team are acutely aware of the risks and ethical challenges involved in conducting such a study. But at the same time, this study was initiated because care home residents often feel lonely and depressed due to social isolation, and simply stopping the study would not improve this.

Therefore, several ways to flexibly respond to the current situation are currenty explored. Adaptations are possible on several levels and may include modified assessment and intervention procedures, in order to safeguard participant safety, trial integrity, and treatment fidelity.

Updates to the study status will be posted here as they emerge.