Clinical trial NCT03496675: Music Interventions for Dementia and Depression in Elderly Care
Official title: Music Interventions for Dementia and Depression in Elderly Care: International Cluster-randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Depression
Lead sponsor: NORCE Norwegian Research Centre AS
Sponsor class: OTHER
Collaborators: name: University of Melbourne
name: University of Oldenburg
name: University Medical Center Groningen
name: Ankara Haci Bayram Veli University
name: University of Nottingham
First posted: 2018-04-12
Enrollment: 1021
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* resident (full-time, 24h/day) at a participating care home;
* dementia as indicated by a Clinical Dementia Rating score of 0.5 or more and a Mini-Mental State Examination (MMSE) score of 26 or less;
* at least mild depressive symptoms, as indicated by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 8;
* a clinical diagnosis of dementia according to ICD-10 research criteria;
* have given written informed consent (may be assent by proxy for those unable to provide consent themselves).

Exclusion Criteria:

* diagnosis of schizophrenia or Parkinson's disease;
* severe hearing-impairment;
* in short-term care;
* unable to tolerate sitting in a chair for the duration of the sessions.

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 6 months
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: up to 24 months
measure: Clinical Dementia Rating (CDR)
timeFrame: 12 months
measure: Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity
timeFrame: 12 months
measure: Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress
timeFrame: 12 months
measure: EuroQol (EQ-5D)
timeFrame: 12 months
measure: Quality of Life in Alzheimer´s Dementia (QOL-AD)
timeFrame: 12 months
measure: All-cause mortality (time to death)
timeFrame: up 24 months
measure: Any increase in medication use (binary, yes/no)
timeFrame: 12 months
measure: Costs
timeFrame: 12 months
measure: Any adverse event [Safety]
timeFrame: 12 months
measure: Professional Care Team Burden Scale
timeFrame: 12 months
measure: Days on sick leave of care staff
timeFrame: 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The University of Melbourne
state: Victoria
city: Oldenburg
country: Germany
facility: Carl von Ossietzky University Oldenburg
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Bergen
country: Norway
facility: NORCE Norwegian Research Centre
state: Vestland
city: Ankara
country: Turkey
facility: Ankara Hacı Bayram Veli University
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: GAMUT, NORCE Norwegian Research Centre, Bergen, Norway
name: Vigdis Sveinsdottir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gold C, Eickholt J, Assmus J, Stige B, Wake JD, Baker FA, Tamplin J, Clark I, Lee YC, Jacobsen SL, Ridder HMO, Kreutz G, Muthesius D, Wosch T, Ceccato E, Raglio A, Ruggeri M, Vink A, Zuidema S, Odell-Miller H, Orrell M, Schneider J, Kubiak C, Romeo R, Geretsegger M. Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial. BMJ Open. 2019 Mar 30;9(3):e023436. doi: 10.1136/bmjopen-2018-023436.
citation: Rasing NL, Janus SIM, Kreutz G, Sveinsdottir V, Gold C, Nater UM, Zuidema SU. The Impact of Music on Stress Biomarkers: Protocol of a Substudy of the Cluster-Randomized Controlled Trial Music Interventions for Dementia and Depression in ELderly Care (MIDDEL). Brain Sci. 2022 Apr 8;12(4):485. doi: 10.3390/brainsci12040485.
citation: Janus, S. I. M., Vink, A. C., Ridder, H. M., Geretsegger, M., Stige, B., Gold, C., & Zuidema, S. U. (2020). Developing consensus description of group music therapy characteristics for persons with dementia. Nordic Journal of Music Therapy, 1-17.
citation: Baker FA, Tamplin J, Clark IN, Lee YC, Geretsegger M, Gold C. Treatment Fidelity in a Music Therapy Multi-site Cluster Randomized Controlled Trial for People Living With Dementia: The MIDDEL Project Intervention Fidelity Protocol. J Music Ther. 2019 May 10;56(2):125-148. doi: 10.1093/jmt/thy023.
citation: Baker FA, Lee YC, Sousa TV, Stretton-Smith PA, Tamplin J, Sveinsdottir V, Geretsegger M, Wake JD, Assmus J, Gold C. Clinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international pragmatic cluster-randomised controlled trial. Lancet Healthy Longev. 2022 Mar;3(3):e153-e165. doi: 10.1016/S2666-7568(22)00027-7.
citation: Baker FA, Stretton-Smith PA, Sousa TV, Clark I, Cotton A, Gold C, Lee YC. Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team. Contemp Clin Trials Commun. 2020 Nov 25;20:100675. doi: 10.1016/j.conctc.2020.100675. eCollection 2020 Dec.
citation: Lee YC, Sousa TV, Stretton-Smith PA, Gold C, Geretsegger M, Baker FA. Demographic and clinical profile of residents living with dementia and depressive symptoms in Australian private residential aged care: Data from the Music Interventions for Dementia and Depression in ELderly care (MIDDEL) cluster-randomised controlled trial. Australas J Ageing. 2022 Dec;41(4):e387-e396. doi: 10.1111/ajag.13104. Epub 2022 Jul 8.