About the project
The overall objective of MIDDEL is to determine the effectiveness of two music-based approaches – group music therapy and recreational choir singing – for reducing depression symptoms in people living with dementia, and to examine 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 six European countries, and a total of 100 care home units will be randomised to one of the four study conditions.
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 will be defined for both interventions before the trial starts, and will be applied and further developed during the trial through process evaluation to improve both interventions.
Trial registration numbers:
- ClinicalTrials.gov: NCT03496675
- ANZCTR: ACTRN12618000156280
Project team and partners
MIDDEL is an international project hosted by GAMUT – The Grieg Academy Music Therapy Research Centre, a twin center collaboration between Uni Research Health and University of Bergen, which links the Australian study site with prospective study sites in Denmark, Germany, Italy, Netherlands, Norway, Poland and the United Kingdom.
The interdisciplinary core team consists of researchers and clinicians with competence in international multicentre trial management, practice and theory related to music interventions for people living with dementia and their caregivers, biostatistics, and various research methodologies.
Members of the international clinical investigators network will help to recruit care homes and participants and will conduct interventions and assessments.
Scientific and clinical advisors will help to assure that the project is highly relevant to service users and thoughtfully designed and conducted.
A Trial Steering Committee (TSC), consisting of clinical investigators, service users or their relatives, and representatives of stakeholder organisations, will closely supervise all aspects of the study.
A Data and Safety Monitoring Committee (DSMC), consisting of three people with strong methodological and clinical expertise who are not otherwise affiliated with the project or its institutions, will give recommendations for action to the research team and the TSC.
The core team at Uni Research Health are:
- Christian Gold | Principal investigator
- Monika Geretsegger | Project coordinator
- Brynjulf Stige | Co-investigator
- Jörg Assmus | Biostatistician
- Jo Dugstad Wake | Information scientist
Collaborating institutions and individuals:
- University of Melbourne, Australia: Felicity Baker (Principal investigator for the Australian part of the project); Imogen Clark, Claire Lee, Jeanette Tamplin (Co-investigators); Tanara Sousa (Health economist)
- Aalborg University, Denmark: Stine Lindahl Jacobsen, Hanne Metter Ridder
- European Clinical Research Infrastructure Network, Paris, France: Valentina Cabral Iversen, Christine Kubiak
- Berlin University of the Arts, Germany: Dorothea Muthesius
- Carl von Ossietzky University Oldenburg, Germany: Gunter Kreutz, Antje Timmer
- University of Applied Sciences Würzburg-Schweinfurt, Germany: Jasmin Eickholt, Thomas Wosch
- University of Pavia, Italy: Alfredo Raglio
- University of Verona, Italy: Enrico Ceccato, Mirella Ruggeri
- University Medical Center Groningen, Netherlands: Sytse Zuidema (Principal investigator for the Dutch part of the project), Sarah Janus, Annemiek C. Vink
- University of Gdańsk, Poland: Łucja Bieleninik
- Anglia Ruskin University, Cambridge, UK: Helen Odell-Miller
- University of Nottingham, UK: Martin Orrell, Justine Schneider
- King’s College London, UK: Renee Romeo
- Evan Dawson, Live Music Now, UK
- Jarle Flemvåg, Krafttak for sang, Norway
- Julene Johnson, University of California, San Francisco, USA
- Inger Hilde Nordhus, University of Bergen, Norway
- Teppo Särkämö, University of Helsinki, Finland
- Geir Selbæk, Norwegian Advisory Unit on Ageing and Health, Norway
Partial funding has been secured and further funding is pending.
- Data collection in Australia is funded by the National Health and Medical Research Council (NHMRC ID APP1137853; official project start: April 01, 2018).
- Consensus development of group music therapy is funded from an internal post-doctoral grant of the University Medical Center Groningen.
Data collection in other countries will follow once funding has been secured.
- Principal investigator: Christian Gold | email@example.com
- Project coordinator: Monika Geretsegger | firstname.lastname@example.org
Meetings & events
November 21-22, 2017:
Project meeting & video conference | Bergen, Norway
Content: preparations for a Delphi process towards a consensus on core principles of group music therapy for older adults with dementia and depression
Meeting led by Sytse Zuidema and Sarah Janus, with participants from Australia, Denmark, Germany, Italy, Netherlands, and Norway
Location: GAMUT, Uni Research Health, Bergen, Norway
April 26, 2018:
Music interventions for dementia & depression in elderly care: Symposium and NH&MRC Project Launch | Melbourne, Australia
Organiser: Faculty of the Victorian College of the Arts and Melbourne Conservatorium of Music
Location: Melbourne Brain Centre, University of Melbourne, Australia
June 22-23, 2018:
Project meeting | Frankfurt, Germany
Content: Practical aspects related to the Australian part of the project
Location: Frankfurt, Germany
Eickholt, J., Geretsegger, M., & Gold, C. (in press). Perspectives on research and clinical practice in music therapy for older people with depression. In A. Zubala & V. Karkou (Eds.), Arts Therapies in the Treatment of Depression. Abingdon, UK: Routledge.
Fusar-Poli, L., Bieleninik, Ł., Brondino, N., Chen, X. J., & Gold, C. (2017). The effect of music therapy on cognitive functions in patients with dementia: A systematic review and meta-analysis. Aging and Mental Health, 1-10. doi: 10.1080/13607863.2017.1348474
Ridder, H. M., Stige, B., Qvale, L. G., & Gold, C. (2013). Individual music therapy for agitation in dementia: An exploratory randomized controlled trial. Aging and Mental Health, 17(6), 667-678. doi: 10.1080/13607863.2013.790926
Tamplin, J., Clark, I., Ridder, H. M., McDermott, O., Odell-Miller, H., Laitinen, S., & Gold, C. (2016). Music therapy research in dementia: Fostering a global approach. Nordic Journal of Music Therapy, 25(sup1), 94-95. doi: 10.1080/08098131.2016.1180095
Werner, J., Wosch, T., & Gold, C. (2017). Effectiveness of group music therapy versus recreational group singing for depressive symptoms of elderly nursing home residents: Pragmatic trial. Aging and Mental Health, 21(2), 147-155. doi: 10.1080/13607863.2015.1093599