Music Interventions for Dementia and Depression in Elderly Care
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dementia
- Depression
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: 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).Primary Purpose: Treatment
Participation Requirements
- Age
- Between 65 years and 125 years
- Gender
- Both males and females
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 depres...
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.
Tracking Information
- NCT #
- NCT03496675
- Collaborators
- University of Melbourne
- University of Oldenburg
- University Medical Center Groningen
- Ankara Haci Bayram Veli University
- University of Nottingham
- Investigators
- Principal Investigator: Vigdis Sveinsdottir, PhD GAMUT, NORCE Norwegian Research Centre, Bergen, Norway
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