Music Interventions for Dementia and Depression in Elderly Care (MIDDEL)

NORCE Norwegian Research Centre AS

Status: Active, not recruiting

Conditions: Depression; Dementia

Treatments: Behavioral: Group Music Therapy; Other: Standard care; Behavioral: Recreational Choir Singing

Study type: Interventional

Funder types: Other

Identifiers

NCT03496675

MIDDEL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,021 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,021 participants in 4 patient groups

Standard care

Other group

Description:

Participants receive standard care as locally available. The components of standard care are recorded.

Treatment:

Other: Standard care

Group Music Therapy (GMT)

Experimental group

Description:

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).

Treatment:

Behavioral: Group Music Therapy

Other: Standard care

Recreational Choir Singing (RCS)

Experimental group

Description:

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).

Treatment:

Other: Standard care

Behavioral: Recreational Choir Singing

GMT + RCS

Experimental group

Description:

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.

Treatment:

Behavioral: Group Music Therapy

Other: Standard care

Behavioral: Recreational Choir Singing