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Completed

NCT Number: NCT03496675

Music Interventions for Dementia and Depression in Elderly Care

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.

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Key information

Conditions

Dementia Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Melbourne, Melbourne, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Music Therapy

Behavioral

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.

Recreational Choir Singing

Behavioral

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.

Standard care

Other

May include pharmacological and non-pharmacological interventions as locally available

Primary outcomes

  1. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 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 outcomes

  1. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 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.

  2. Clinical Dementia Rating (CDR)

    Time frame: 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.

  3. Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity

    Time frame: 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.

  4. Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress

    Time frame: 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.

  5. EuroQol (EQ-5D)

    Time frame: 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.

  6. Quality of Life in Alzheimer´s Dementia (QOL-AD)

    Time frame: 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.

  7. All-cause mortality (time to death)

    Time frame: up 24 months

    Data on participant deaths will be collected from care staff on a monthly basis.

  8. Any increase in medication use (binary, yes/no)

    Time frame: 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.

  9. Costs

    Time frame: 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.

  10. Any adverse event [Safety]

    Time frame: 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.

  11. Professional Care Team Burden Scale

    Time frame: 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.

  12. Days on sick leave of care staff

    Time frame: 12 months

    (as recorded monthly by the employer)

Sponsors and collaborators

Lead sponsor

NORCE Norwegian Research Centre AS

Other

Collaborators

  • Ankara Haci Bayram Veli University
  • University Medical Center Groningen
  • University of Melbourne
  • University of Nottingham
  • University of Oldenburg

Registry information

Official study title

Music Interventions for Dementia and Depression in Elderly Care: International Cluster-randomised Controlled Trial

Acronym: MIDDEL

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2018
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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