Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial.
Identifieur interne : 000556 ( Main/Corpus ); précédent : 000555; suivant : 000557Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial.
Auteurs : Christian Gold ; Jasmin Eickholt ; Jörg Assmus ; 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 ; Martin Orrell ; Justine Schneider ; Christine Kubiak ; Renee Romeo ; Monika GeretseggerSource :
- BMJ open [ 2044-6055 ] ; 2019.
English descriptors
- KwdEn :
- Aged (MeSH), Cluster Analysis (MeSH), Dementia (therapy), Depression (therapy), Geriatric Assessment (MeSH), Homes for the Aged (MeSH), Humans (MeSH), Multicenter Studies as Topic (MeSH), Music Therapy (methods), Nursing Homes (MeSH), Quality of Life (MeSH), Randomized Controlled Trials as Topic (MeSH), Recreation Therapy (methods), Singing (MeSH).
- MESH :
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.
DOI: 10.1136/bmjopen-2018-023436
PubMed: 30928926
PubMed Central: PMC6475205
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial.</title><author><name sortKey="Gold, Christian" sort="Gold, Christian" uniqKey="Gold C" first="Christian" last="Gold">Christian Gold</name><affiliation><nlm:affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</nlm:affiliation></affiliation></author><author><name sortKey="Eickholt, Jasmin" sort="Eickholt, Jasmin" uniqKey="Eickholt J" first="Jasmin" last="Eickholt">Jasmin Eickholt</name><affiliation><nlm:affiliation>Faculty of Applied Social Sciences, University of Applied Sciences Würzburg-Schweinfurt, Würzburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Assmus, Jorg" sort="Assmus, Jorg" uniqKey="Assmus J" first="Jörg" last="Assmus">Jörg Assmus</name><affiliation><nlm:affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</nlm:affiliation></affiliation></author><author><name sortKey="Stige, Brynjulf" sort="Stige, Brynjulf" uniqKey="Stige B" first="Brynjulf" last="Stige">Brynjulf Stige</name><affiliation><nlm:affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</nlm:affiliation></affiliation></author><author><name sortKey="Wake, Jo Dugstad" sort="Wake, Jo Dugstad" uniqKey="Wake J" first="Jo Dugstad" last="Wake">Jo Dugstad Wake</name><affiliation><nlm:affiliation>NORCE Norwegian Research Centre, Bergen, Norway.</nlm:affiliation></affiliation></author><author><name sortKey="Baker, Felicity Anne" sort="Baker, Felicity Anne" uniqKey="Baker F" first="Felicity Anne" last="Baker">Felicity Anne Baker</name><affiliation><nlm:affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Tamplin, Jeanette" sort="Tamplin, Jeanette" uniqKey="Tamplin J" first="Jeanette" last="Tamplin">Jeanette Tamplin</name><affiliation><nlm:affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Clark, Imogen" sort="Clark, Imogen" uniqKey="Clark I" first="Imogen" last="Clark">Imogen Clark</name><affiliation><nlm:affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Lee, Young Eun Claire" sort="Lee, Young Eun Claire" uniqKey="Lee Y" first="Young-Eun Claire" last="Lee">Young-Eun Claire Lee</name><affiliation><nlm:affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Jacobsen, Stine Lindahl" sort="Jacobsen, Stine Lindahl" uniqKey="Jacobsen S" first="Stine Lindahl" last="Jacobsen">Stine Lindahl Jacobsen</name><affiliation><nlm:affiliation>Department of Communication and Psychology, Aalborg University, Aalborg, Denmark.</nlm:affiliation></affiliation></author><author><name sortKey="Ridder, Hanne Mette Ochsner" sort="Ridder, Hanne Mette Ochsner" uniqKey="Ridder H" first="Hanne Mette Ochsner" last="Ridder">Hanne Mette Ochsner Ridder</name><affiliation><nlm:affiliation>Department of Communication and Psychology, Aalborg University, Aalborg, Denmark.</nlm:affiliation></affiliation></author><author><name sortKey="Kreutz, Gunter" sort="Kreutz, Gunter" uniqKey="Kreutz G" first="Gunter" last="Kreutz">Gunter Kreutz</name><affiliation><nlm:affiliation>Department of Music, Carl von Ossietzky University Oldenburg, Oldenburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Muthesius, Dorothea" sort="Muthesius, Dorothea" uniqKey="Muthesius D" first="Dorothea" last="Muthesius">Dorothea Muthesius</name><affiliation><nlm:affiliation>Berlin University of the Arts, Berlin, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Wosch, Thomas" sort="Wosch, Thomas" uniqKey="Wosch T" first="Thomas" last="Wosch">Thomas Wosch</name><affiliation><nlm:affiliation>Faculty of Applied Social Sciences, University of Applied Sciences Würzburg-Schweinfurt, Würzburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Ceccato, Enrico" sort="Ceccato, Enrico" uniqKey="Ceccato E" first="Enrico" last="Ceccato">Enrico Ceccato</name><affiliation><nlm:affiliation>Department of Mental Health, Azienda ULSS 8 Berica, Vicenza, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Raglio, Alfredo" sort="Raglio, Alfredo" uniqKey="Raglio A" first="Alfredo" last="Raglio">Alfredo Raglio</name><affiliation><nlm:affiliation>Music Therapy Research Laboratory, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Ruggeri, Mirella" sort="Ruggeri, Mirella" uniqKey="Ruggeri M" first="Mirella" last="Ruggeri">Mirella Ruggeri</name><affiliation><nlm:affiliation>Public Health and Community Medicine, University of Verona, Verona, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Vink, Annemiek" sort="Vink, Annemiek" uniqKey="Vink A" first="Annemiek" last="Vink">Annemiek Vink</name><affiliation><nlm:affiliation>Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Music therapy Department, Academy of Music, ArtEZ University of the Arts, Enschede, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Zuidema, Sytse" sort="Zuidema, Sytse" uniqKey="Zuidema S" first="Sytse" last="Zuidema">Sytse Zuidema</name><affiliation><nlm:affiliation>Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Odell Miller, Helen" sort="Odell Miller, Helen" uniqKey="Odell Miller H" first="Helen" last="Odell-Miller">Helen Odell-Miller</name><affiliation><nlm:affiliation>The Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Orrell, Martin" sort="Orrell, Martin" uniqKey="Orrell M" first="Martin" last="Orrell">Martin Orrell</name><affiliation><nlm:affiliation>Institute of Mental Health, University of Nottingham, Nottingham, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Schneider, Justine" sort="Schneider, Justine" uniqKey="Schneider J" first="Justine" last="Schneider">Justine Schneider</name><affiliation><nlm:affiliation>School of Sociology and Social Policy, University of Nottingham, Nottingham, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Kubiak, Christine" sort="Kubiak, Christine" uniqKey="Kubiak C" first="Christine" last="Kubiak">Christine Kubiak</name><affiliation><nlm:affiliation>European Clinical Research Infrastructure Network (ECRIN), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Romeo, Renee" sort="Romeo, Renee" uniqKey="Romeo R" first="Renee" last="Romeo">Renee Romeo</name><affiliation><nlm:affiliation>King's Health Economics, King's College London, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Geretsegger, Monika" sort="Geretsegger, Monika" uniqKey="Geretsegger M" first="Monika" last="Geretsegger">Monika Geretsegger</name><affiliation><nlm:affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2019">2019</date><idno type="RBID">pubmed:30928926</idno><idno type="pmid">30928926</idno><idno type="doi">10.1136/bmjopen-2018-023436</idno><idno type="pmc">PMC6475205</idno><idno type="wicri:Area/Main/Corpus">000556</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000556</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial.</title><author><name sortKey="Gold, Christian" sort="Gold, Christian" uniqKey="Gold C" first="Christian" last="Gold">Christian Gold</name><affiliation><nlm:affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</nlm:affiliation></affiliation></author><author><name sortKey="Eickholt, Jasmin" sort="Eickholt, Jasmin" uniqKey="Eickholt J" first="Jasmin" last="Eickholt">Jasmin Eickholt</name><affiliation><nlm:affiliation>Faculty of Applied Social Sciences, University of Applied Sciences Würzburg-Schweinfurt, Würzburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Assmus, Jorg" sort="Assmus, Jorg" uniqKey="Assmus J" first="Jörg" last="Assmus">Jörg Assmus</name><affiliation><nlm:affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</nlm:affiliation></affiliation></author><author><name sortKey="Stige, Brynjulf" sort="Stige, Brynjulf" uniqKey="Stige B" first="Brynjulf" last="Stige">Brynjulf Stige</name><affiliation><nlm:affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</nlm:affiliation></affiliation></author><author><name sortKey="Wake, Jo Dugstad" sort="Wake, Jo Dugstad" uniqKey="Wake J" first="Jo Dugstad" last="Wake">Jo Dugstad Wake</name><affiliation><nlm:affiliation>NORCE Norwegian Research Centre, Bergen, Norway.</nlm:affiliation></affiliation></author><author><name sortKey="Baker, Felicity Anne" sort="Baker, Felicity Anne" uniqKey="Baker F" first="Felicity Anne" last="Baker">Felicity Anne Baker</name><affiliation><nlm:affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Tamplin, Jeanette" sort="Tamplin, Jeanette" uniqKey="Tamplin J" first="Jeanette" last="Tamplin">Jeanette Tamplin</name><affiliation><nlm:affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Clark, Imogen" sort="Clark, Imogen" uniqKey="Clark I" first="Imogen" last="Clark">Imogen Clark</name><affiliation><nlm:affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Lee, Young Eun Claire" sort="Lee, Young Eun Claire" uniqKey="Lee Y" first="Young-Eun Claire" last="Lee">Young-Eun Claire Lee</name><affiliation><nlm:affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Jacobsen, Stine Lindahl" sort="Jacobsen, Stine Lindahl" uniqKey="Jacobsen S" first="Stine Lindahl" last="Jacobsen">Stine Lindahl Jacobsen</name><affiliation><nlm:affiliation>Department of Communication and Psychology, Aalborg University, Aalborg, Denmark.</nlm:affiliation></affiliation></author><author><name sortKey="Ridder, Hanne Mette Ochsner" sort="Ridder, Hanne Mette Ochsner" uniqKey="Ridder H" first="Hanne Mette Ochsner" last="Ridder">Hanne Mette Ochsner Ridder</name><affiliation><nlm:affiliation>Department of Communication and Psychology, Aalborg University, Aalborg, Denmark.</nlm:affiliation></affiliation></author><author><name sortKey="Kreutz, Gunter" sort="Kreutz, Gunter" uniqKey="Kreutz G" first="Gunter" last="Kreutz">Gunter Kreutz</name><affiliation><nlm:affiliation>Department of Music, Carl von Ossietzky University Oldenburg, Oldenburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Muthesius, Dorothea" sort="Muthesius, Dorothea" uniqKey="Muthesius D" first="Dorothea" last="Muthesius">Dorothea Muthesius</name><affiliation><nlm:affiliation>Berlin University of the Arts, Berlin, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Wosch, Thomas" sort="Wosch, Thomas" uniqKey="Wosch T" first="Thomas" last="Wosch">Thomas Wosch</name><affiliation><nlm:affiliation>Faculty of Applied Social Sciences, University of Applied Sciences Würzburg-Schweinfurt, Würzburg, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Ceccato, Enrico" sort="Ceccato, Enrico" uniqKey="Ceccato E" first="Enrico" last="Ceccato">Enrico Ceccato</name><affiliation><nlm:affiliation>Department of Mental Health, Azienda ULSS 8 Berica, Vicenza, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Raglio, Alfredo" sort="Raglio, Alfredo" uniqKey="Raglio A" first="Alfredo" last="Raglio">Alfredo Raglio</name><affiliation><nlm:affiliation>Music Therapy Research Laboratory, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Ruggeri, Mirella" sort="Ruggeri, Mirella" uniqKey="Ruggeri M" first="Mirella" last="Ruggeri">Mirella Ruggeri</name><affiliation><nlm:affiliation>Public Health and Community Medicine, University of Verona, Verona, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Vink, Annemiek" sort="Vink, Annemiek" uniqKey="Vink A" first="Annemiek" last="Vink">Annemiek Vink</name><affiliation><nlm:affiliation>Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Music therapy Department, Academy of Music, ArtEZ University of the Arts, Enschede, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Zuidema, Sytse" sort="Zuidema, Sytse" uniqKey="Zuidema S" first="Sytse" last="Zuidema">Sytse Zuidema</name><affiliation><nlm:affiliation>Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.</nlm:affiliation></affiliation></author><author><name sortKey="Odell Miller, Helen" sort="Odell Miller, Helen" uniqKey="Odell Miller H" first="Helen" last="Odell-Miller">Helen Odell-Miller</name><affiliation><nlm:affiliation>The Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Orrell, Martin" sort="Orrell, Martin" uniqKey="Orrell M" first="Martin" last="Orrell">Martin Orrell</name><affiliation><nlm:affiliation>Institute of Mental Health, University of Nottingham, Nottingham, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Schneider, Justine" sort="Schneider, Justine" uniqKey="Schneider J" first="Justine" last="Schneider">Justine Schneider</name><affiliation><nlm:affiliation>School of Sociology and Social Policy, University of Nottingham, Nottingham, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Kubiak, Christine" sort="Kubiak, Christine" uniqKey="Kubiak C" first="Christine" last="Kubiak">Christine Kubiak</name><affiliation><nlm:affiliation>European Clinical Research Infrastructure Network (ECRIN), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Romeo, Renee" sort="Romeo, Renee" uniqKey="Romeo R" first="Renee" last="Romeo">Renee Romeo</name><affiliation><nlm:affiliation>King's Health Economics, King's College London, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Geretsegger, Monika" sort="Geretsegger, Monika" uniqKey="Geretsegger M" first="Monika" last="Geretsegger">Monika Geretsegger</name><affiliation><nlm:affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</nlm:affiliation></affiliation></author></analytic><series><title level="j">BMJ open</title><idno type="eISSN">2044-6055</idno><imprint><date when="2019" type="published">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged (MeSH)</term><term>Cluster Analysis (MeSH)</term><term>Dementia (therapy)</term><term>Depression (therapy)</term><term>Geriatric Assessment (MeSH)</term><term>Homes for the Aged (MeSH)</term><term>Humans (MeSH)</term><term>Multicenter Studies as Topic (MeSH)</term><term>Music Therapy (methods)</term><term>Nursing Homes (MeSH)</term><term>Quality of Life (MeSH)</term><term>Randomized Controlled Trials as Topic (MeSH)</term><term>Recreation Therapy (methods)</term><term>Singing (MeSH)</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Music Therapy</term><term>Recreation Therapy</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Dementia</term><term>Depression</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Cluster Analysis</term><term>Geriatric Assessment</term><term>Homes for the Aged</term><term>Humans</term><term>Multicenter Studies as Topic</term><term>Nursing Homes</term><term>Quality of Life</term><term>Randomized Controlled Trials as Topic</term><term>Singing</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>INTRODUCTION</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS AND ANALYSIS</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>ETHICS AND DISSEMINATION</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION NUMBERS</b></p><p>NCT03496675; Pre-results, ACTRN12618000156280.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">30928926</PMID><DateCompleted><Year>2020</Year><Month>04</Month><Day>03</Day></DateCompleted><DateRevised><Year>2020</Year><Month>04</Month><Day>03</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">2044-6055</ISSN><JournalIssue CitedMedium="Internet"><Volume>9</Volume><Issue>3</Issue><PubDate><Year>2019</Year><Month>03</Month><Day>30</Day></PubDate></JournalIssue><Title>BMJ open</Title><ISOAbbreviation>BMJ Open</ISOAbbreviation></Journal><ArticleTitle>Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial.</ArticleTitle><Pagination><MedlinePgn>e023436</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1136/bmjopen-2018-023436</ELocationID><Abstract><AbstractText Label="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.</AbstractText><AbstractText Label="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.</AbstractText><AbstractText Label="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.</AbstractText><AbstractText Label="TRIAL REGISTRATION NUMBERS">NCT03496675; Pre-results, ACTRN12618000156280.</AbstractText><CopyrightInformation>© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gold</LastName><ForeName>Christian</ForeName><Initials>C</Initials><Identifier Source="ORCID">0000-0002-8654-7474</Identifier><AffiliationInfo><Affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Eickholt</LastName><ForeName>Jasmin</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Faculty of Applied Social Sciences, University of Applied Sciences Würzburg-Schweinfurt, Würzburg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Assmus</LastName><ForeName>Jörg</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stige</LastName><ForeName>Brynjulf</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wake</LastName><ForeName>Jo Dugstad</ForeName><Initials>JD</Initials><AffiliationInfo><Affiliation>NORCE Norwegian Research Centre, Bergen, Norway.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Baker</LastName><ForeName>Felicity Anne</ForeName><Initials>FA</Initials><AffiliationInfo><Affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tamplin</LastName><ForeName>Jeanette</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Clark</LastName><ForeName>Imogen</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lee</LastName><ForeName>Young-Eun Claire</ForeName><Initials>YC</Initials><AffiliationInfo><Affiliation>Faculty of Fine Arts and Music, University of Melbourne, Southbank, Victoria, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jacobsen</LastName><ForeName>Stine Lindahl</ForeName><Initials>SL</Initials><AffiliationInfo><Affiliation>Department of Communication and Psychology, Aalborg University, Aalborg, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ridder</LastName><ForeName>Hanne Mette Ochsner</ForeName><Initials>HMO</Initials><AffiliationInfo><Affiliation>Department of Communication and Psychology, Aalborg University, Aalborg, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kreutz</LastName><ForeName>Gunter</ForeName><Initials>G</Initials><Identifier Source="ORCID">0000-0001-9586-241X</Identifier><AffiliationInfo><Affiliation>Department of Music, Carl von Ossietzky University Oldenburg, Oldenburg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Muthesius</LastName><ForeName>Dorothea</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Berlin University of the Arts, Berlin, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wosch</LastName><ForeName>Thomas</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Faculty of Applied Social Sciences, University of Applied Sciences Würzburg-Schweinfurt, Würzburg, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ceccato</LastName><ForeName>Enrico</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Mental Health, Azienda ULSS 8 Berica, Vicenza, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Raglio</LastName><ForeName>Alfredo</ForeName><Initials>A</Initials><Identifier Source="ORCID">0000-0003-3047-8948</Identifier><AffiliationInfo><Affiliation>Music Therapy Research Laboratory, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ruggeri</LastName><ForeName>Mirella</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Public Health and Community Medicine, University of Verona, Verona, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vink</LastName><ForeName>Annemiek</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Music therapy Department, Academy of Music, ArtEZ University of the Arts, Enschede, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zuidema</LastName><ForeName>Sytse</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Odell-Miller</LastName><ForeName>Helen</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>The Cambridge Institute for Music Therapy Research, Anglia Ruskin University, Cambridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Orrell</LastName><ForeName>Martin</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Institute of Mental Health, University of Nottingham, Nottingham, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schneider</LastName><ForeName>Justine</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>School of Sociology and Social Policy, University of Nottingham, Nottingham, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kubiak</LastName><ForeName>Christine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>European Clinical Research Infrastructure Network (ECRIN), Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Romeo</LastName><ForeName>Renee</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>King's Health Economics, King's College London, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Geretsegger</LastName><ForeName>Monika</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>GAMUT - The Grieg Academy Music Therapy Research Centre, NORCE Norwegian Research Centre, Bergen, Norway.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT03496675</AccessionNumber></AccessionNumberList></DataBank><DataBank><DataBankName>ANZCTR</DataBankName><AccessionNumberList><AccessionNumber>ACTRN12618000156280</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D000078325">Clinical Trial Protocol</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2019</Year><Month>03</Month><Day>30</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>BMJ Open</MedlineTA><NlmUniqueID>101552874</NlmUniqueID><ISSNLinking>2044-6055</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016000" MajorTopicYN="N">Cluster Analysis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003704" MajorTopicYN="N">Dementia</DescriptorName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003863" MajorTopicYN="N">Depression</DescriptorName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015577" MajorTopicYN="N">Geriatric Assessment</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006707" MajorTopicYN="N">Homes for the Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015337" MajorTopicYN="N">Multicenter Studies as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009147" MajorTopicYN="N">Music Therapy</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009735" MajorTopicYN="Y">Nursing Homes</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011788" MajorTopicYN="N">Quality of Life</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D057173" MajorTopicYN="N">Recreation Therapy</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D063346" MajorTopicYN="Y">Singing</DescriptorName></MeshHeading></MeshHeadingList><KeywordList 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