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

  • STATUS
    Recruiting
  • End date
    Jul 22, 2025
  • participants needed
    1000
  • sponsor
    NORCE Norwegian Research Centre AS
Updated on 22 March 2022
depression
anxiety
dementia
depressive symptoms
depressed mood
mini-mental state examination
mental state examination

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.

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.

Details
Condition Dementia, Depression
Treatment Standard Care, Group Music Therapy, Recreational Choir Singing
Clinical Study IdentifierNCT03496675
SponsorNORCE Norwegian Research Centre AS
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note