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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,021
The core intention of GMT is to meet the psychosocial needs of each person living with dementia, which in turn is thought to reduce depressive symptoms and anxiety and to stimulate overall social and emotional wellbeing. It includes active, reciprocal music making with the use of singing and musical instruments. GMT is provided by a trained music therapist, highly skilled as a musician, and registered with the appropriate professional association in his or her country.
RCS is intended to foster connectedness in a group, wellbeing, and enjoyment of music making in a group. It includes singing familiar songs and providing a familiar musical environment for participants. RCS is provided by a musician with choir leading skills.
The University of Melbourne
Melbourne, Victoria, Australia
Carl von Ossietzky University Oldenburg
Oldenburg, Germany
University Medical Centre Groningen
Groningen, Netherlands
NORCE Norwegian Research Centre
Bergen, Vestland, Norway
Montgomery-Åsberg Depression Rating Scale (MADRS)
10-item scale where each item is rated from 0 to 6 ('no abnormality' to 'severe'), yielding a total sum score between 0 and 60, with higher values indicating more severe symptom levels.
Time frame: 6 months
Montgomery-Åsberg Depression Rating Scale (MADRS)
10-item scale where each item is rated from 0 to 6 ('no abnormality' to 'severe'), yielding a total sum score between 0 and 60, with higher values indicating more severe symptom levels.
Time frame: up to 24 months
Clinical Dementia Rating (CDR)
Semi-structured interview with the person living with dementia and an appropriate caregiver/relative; rates impairment across 6 cognitive categories (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care). The CDR score can range from 0 (normal) to 3 (severe dementia); not used at all sites.
Time frame: 12 months
Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity
Includes 12 domains where if a symptom is present, its severity (from 1 = mild to 3 = severe) is assessed by a caregiver familiar with the participant's behaviour. Higher scores (sums of all items, range 0 to 36) represent higher severity.
Time frame: 12 months
Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress
Includes 12 domains where if a symptom is present, the associated distress on caregivers (from 0 = not distressing at all to 5 = extreme or very severe) is assessed by a caregiver familiar with the participant's behaviour. Higher scores (sums of all items, range 0 to 60) represent higher severity.
Time frame: 12 months
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May include pharmacological and non-pharmacological interventions as locally available
Ankara Hacı Bayram Veli University
Ankara, Turkey (Türkiye)
University of Nottingham
Nottingham, United Kingdom
EuroQol (EQ-5D)
Standardized, non-disease-specific instrument for evaluating health-related quality of life, defining health in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Response categories range from "no problems" to "extreme problems". Scores are derived using a weighted scoring method and can range from 0 = worst possible to 1 = best possible quality of life.
Time frame: 12 months
Quality of Life in Alzheimer´s Dementia (QOL-AD)
13-item scale with self-rating and proxy version. Each item ranges from 1 (poor) to 4 (excellent), yielding a total sum score of 13 to 52.
Time frame: 12 months
All-cause mortality (time to death)
Data on participant deaths will be collected from care staff on a monthly basis.
Time frame: up 24 months
Any increase in medication use (binary, yes/no)
Data on type (ATC Codes N065, N06) of medication used and any increase or decrease over time will be collected from care staff using the 'medication profile' section of a tailored version of the Client Socio-Demographic and Service Receipt Inventory (CSSRI), or from available databases.
Time frame: 12 months
Costs
Total and component costs of the interventions are assessed from a societal perspective, including the cost of the intervention as well as statutory health and social care services used, using a tailored version of the Client Socio-Demographic and Service Receipt Inventory (CSSRI). Total cost per participant will be calculated in Euros.
Time frame: 12 months
Any adverse event [Safety]
All types of adverse events and serious adverse events (e.g. unexpected worsening of symptoms), whether related or unrelated to the interventions, are reported.
Time frame: 12 months
Professional Care Team Burden Scale
10-item scale to obtain ratings of burden from formal care teams working in care homes. Items are scored on a 5-point scale from 0 (strongly disagree) to 4 (strongly agree), yielding a total sum score from 0 to 40, with higher scores indicating higher burden.
Time frame: 12 months
Days on sick leave of care staff
(as recorded monthly by the employer)
Time frame: 12 months