Dementia, Depression
Conditions
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.
Interventions
BEHAVIORALGroup Music Therapy
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.
BEHAVIORALRecreational Choir Singing
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.
OTHERStandard care
May include pharmacological and non-pharmacological interventions as locally available
Sponsors
University of Melbourne
University of Oldenburg
University Medical Center Groningen
Ankara Haci Bayram Veli University
University of Nottingham
NORCE Norwegian Research Centre AS
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding of assessors will be ensured by using assessors who do not participate in the daily care of each unit. Assessors will also remind participants not to reveal the unit's allocation to them. At the time of the last assessment, success of blinding will be verified by asking assessors whether they inadvertently discovered the unit's allocation. Intervention providers and study participants (PLWD and staff) cannot be blinded due to the nature of the interventions. However, efforts will be made to ensure that no differential expectations are created and equipoise is maintained (e.g., by careful wording of the patient information and consent form).
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Dementia Rating (CDR) | 12 months | 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. |
| Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity | 12 months | 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. |
| Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress | 12 months | 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. |
| EuroQol (EQ-5D) | 12 months | 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. |
| Quality of Life in Alzheimer´s Dementia (QOL-AD) | 12 months | 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. |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | up to 24 months | 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. |
| Any increase in medication use (binary, yes/no) | 12 months | 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. |
| Costs | 12 months | 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. |
| Any adverse event [Safety] | 12 months | All types of adverse events and serious adverse events (e.g. unexpected worsening of symptoms), whether related or unrelated to the interventions, are reported. |
| Professional Care Team Burden Scale | 12 months | 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. |
| Days on sick leave of care staff | 12 months | (as recorded monthly by the employer) |
| All-cause mortality (time to death) | up 24 months | Data on participant deaths will be collected from care staff on a monthly basis. |
Countries
Australia, Germany, Netherlands, Norway, Turkey (Türkiye), United Kingdom
Outcome results
None listed