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Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial
  1. Christian Gold1,
  2. Jasmin Eickholt2,
  3. Jörg Assmus1,
  4. Brynjulf Stige1,
  5. Jo Dugstad Wake3,
  6. Felicity Anne Baker4,
  7. Jeanette Tamplin4,
  8. Imogen Clark4,
  9. Young-Eun Claire Lee4,
  10. Stine Lindahl Jacobsen5,
  11. Hanne Mette Ochsner Ridder5,
  12. Gunter Kreutz6,
  13. Dorothea Muthesius7,
  14. Thomas Wosch2,
  15. Enrico Ceccato8,
  16. Alfredo Raglio9,
  17. Mirella Ruggeri10,
  18. Annemiek Vink11,12,
  19. Sytse Zuidema11,
  20. Helen Odell-Miller13,
  21. Martin Orrell14,
  22. Justine Schneider15,
  23. Christine Kubiak16,
  24. Renee Romeo17,
  25. Monika Geretsegger1
  1. 1 GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway
  2. 2 Faculty of Applied Social Sciences, University of Applied Sciences Würzburg-Schweinfurt, Würzburg, Germany
  3. 3 NORCE Norwegian Research Centre, Bergen, Norway
  4. 4 Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia
  5. 5 Department of Communication and Psychology, Aalborg University, Aalborg, Denmark
  6. 6 Department of Music, Carl von Ossietzky University Oldenburg, Oldenburg, Germany
  7. 7 Berlin University of the Arts, Berlin, Germany
  8. 8 Department of Mental Health, Azienda ULSS 8 Berica, Vicenza, Italy
  9. 9 Music Therapy Research Laboratory, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy
  10. 10 Public Health and Community Medicine, University of Verona, Verona, Italy
  11. 11 Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  12. 12 Music therapy Department, Academy of Music, ArtEZ University of the Arts, Enschede, The Netherlands
  13. 13 The Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK
  14. 14 Institute of Mental Health, University of Nottingham, Nottingham, UK
  15. 15 School of Sociology and Social Policy, University of Nottingham, Nottingham, UK
  16. 16 European Clinical Research Infrastructure Network (ECRIN), Paris, France
  17. 17 King’s Health Economics, King’s College London, London, UK
  1. Correspondence to Dr Christian Gold; christian.gold{at}norceresearch.no

Abstract

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.

Trial registration numbers NCT03496675; Pre-results, ACTRN12618000156280.

  • dementia
  • neurology
  • psychiatry
  • depression & mood disorders
  • care homes
  • music therapy
  • music interventions
  • psychiatry
  • old age psychiatry

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Footnotes

  • Contributors CG took the initiative for the study; CG, JE, JA, BS, HMOR, SZ and RR developed the concept and design; FAB, JT, IC, YCL, GK, DM, TW, EC, AR, MR, AV, HOM, MO, JS, and MG helped to revise the concept and design. CG drafted the manuscript; JE, JA, RR, and MG helped drafting the manuscript. BS, JDW, FAB, JT, IC, YCL, SLJ, HMOR, GK, DM, TW, EC, AR, MR, AV, SZ, HOM, MO, JS, CK revised the manuscript for important intellectual content. CG, FAB, JT, IC, HMOR, and SZ obtained funding. BS, FAB, JT, IC, YCL, SLJ, HMOR, GK, DM, TW, EC, AR, MR, AV, SZ, HOM, and MG were involved in setting up the study conduct in each site. JDW, FAB, JT, IC, YCL, CK, and MG provided administrative, technical, or material support. All authors approved the final version of the manuscript.

  • Funding This work was supported by an Australian National Health and Medical Research Council Grant (grant number APP1137853) and by intramural support from Uni Research AS and University Medical Center Groningen.

  • Competing interests None declared.

  • Ethics approval Ethical approval has been obtained from the Medicine and Dentistry Human Ethics Sub-Committee at the University of Melbourne, Australia (approval date: January 12, 2018).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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