An interventional study of Group Music Therapy and Recreational Choir Singing in Dementia and Depression, sponsored by NORCE Norwegian Research Centre AS. Completed at 6 sites in 6 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by NORCE Norwegian Research Centre AS · Not applicable, Interventional, and Treatment
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.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's enrollment of 1,021 is above the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →NORCE Norwegian Research Centre AS is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard care as locally available. The components of standard care are recorded.
Other: Standard care
GMT is provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each. In line with usual practice, and as appropriate in local contexts, residents of a unit allocated to GMT may be divided into smaller groups (e.g. around 5 participants).
Behavioral: Group Music Therapy · Other: Standard care
RCS is provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each. RCS may be conducted in larger groups (e.g. with all residents of the unit in one group).
Behavioral: Recreational Choir Singing · Other: Standard care
Group Music Therapy and Recreational Choir Singing are both provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each.
Behavioral: Group Music Therapy · Behavioral: Recreational Choir Singing · Other: Standard care
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.
May include pharmacological and non-pharmacological interventions as locally available
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
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
Plan to share: Yes — De-identified datasets (participant codes and outcome scores) generated during and/or analysed during the current study will be stored in a publically available repository (NSD - Norwegian Centre for Research Data, http://www.nsd.uib.no/nsd/english/index.html).
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will become available upon publication of the primary outcome.
Access criteria: De-identified IPD will be publicly available at the Norwegian Centre for Research Data (http://www.nsd.uib.no/nsd/english/index.html).
Ran from Jul 2018 to primary completion in Sep 2023, 62 months.
Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 62 months is above that.
Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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NORCE Norwegian Research Centre AS