Music Interventions for Dementia and Depression in Elderly Care

Depression Clinical Trial

— MIDDEL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03496675
• Other study ID #: MIDDEL
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: January 2024

Study information

• Verified date: December 2023
• Source: NORCE Norwegian Research Centre AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1021
• Est. completion date: January 2024
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Group 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.
• Recreational 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.

Other:
• Standard care
May include pharmacological and non-pharmacological interventions as locally available

Locations

Country	Name	City	State
Australia	The University of Melbourne	Melbourne	Victoria
Germany	Carl von Ossietzky University Oldenburg	Oldenburg
Netherlands	University Medical Centre Groningen	Groningen
Norway	NORCE Norwegian Research Centre	Bergen	Vestland
Turkey	Ankara Haci Bayram Veli University	Ankara
United Kingdom	University of Nottingham	Nottingham

Sponsors (6)

Lead Sponsor	Collaborator
NORCE Norwegian Research Centre AS	Ankara Haci Bayram Veli University, University Medical Center Groningen, University of Melbourne, University of Nottingham, University of Oldenburg

Countries where clinical trial is conducted

Australia,  Germany,  Netherlands,  Norway,  Turkey,  United Kingdom, 

References & Publications (7)

Baker FA, Lee YC, Sousa TV, Stretton-Smith PA, Tamplin J, Sveinsdottir V, Geretsegger M, Wake JD, Assmus J, Gold C. Clinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international p — View Citation

Baker FA, Stretton-Smith PA, Sousa TV, Clark I, Cotton A, Gold C, Lee YC. Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team. Contemp Clin Trials Com — View Citation

Baker FA, Tamplin J, Clark IN, Lee YC, Geretsegger M, Gold C. Treatment Fidelity in a Music Therapy Multi-site Cluster Randomized Controlled Trial for People Living With Dementia: The MIDDEL Project Intervention Fidelity Protocol. J Music Ther. 2019 May 1 — View Citation

Gold C, Eickholt J, Assmus J, Stige B, Wake JD, Baker FA, Tamplin J, Clark I, Lee YC, Jacobsen SL, Ridder HMO, Kreutz G, Muthesius D, Wosch T, Ceccato E, Raglio A, Ruggeri M, Vink A, Zuidema S, Odell-Miller H, Orrell M, Schneider J, Kubiak C, Romeo R, Geretsegger M. Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial. BMJ Open. 2019 Mar 30;9(3):e023436. doi: 10.1136/bmjopen-2018-023436. — View Citation

Janus, S. I. M., Vink, A. C., Ridder, H. M., Geretsegger, M., Stige, B., Gold, C., & Zuidema, S. U. (2020). Developing consensus description of group music therapy characteristics for persons with dementia. Nordic Journal of Music Therapy, 1-17.

Lee YC, Sousa TV, Stretton-Smith PA, Gold C, Geretsegger M, Baker FA. Demographic and clinical profile of residents living with dementia and depressive symptoms in Australian private residential aged care: Data from the Music Interventions for Dementia an — View Citation

Rasing NL, Janus SIM, Kreutz G, Sveinsdottir V, Gold C, Nater UM, Zuidema SU. The Impact of Music on Stress Biomarkers: Protocol of a Substudy of the Cluster-Randomized Controlled Trial Music Interventions for Dementia and Depression in ELderly Care (MIDDEL). Brain Sci. 2022 Apr 8;12(4):485. doi: 10.3390/brainsci12040485. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg Depression Rating Scale (MADRS)	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.	6 months
Secondary	Montgomery-Åsberg Depression Rating Scale (MADRS)	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.	up to 24 months
Secondary	Clinical Dementia Rating (CDR)	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.	12 months
Secondary	Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity	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.	12 months
Secondary	Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress	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.	12 months
Secondary	EuroQol (EQ-5D)	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.	12 months
Secondary	Quality of Life in Alzheimer´s Dementia (QOL-AD)	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.	12 months
Secondary	All-cause mortality (time to death)	Data on participant deaths will be collected from care staff on a monthly basis.	up 24 months
Secondary	Any increase in medication use (binary, yes/no)	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.	12 months
Secondary	Costs	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.	12 months
Secondary	Any adverse event [Safety]	All types of adverse events and serious adverse events (e.g. unexpected worsening of symptoms), whether related or unrelated to the interventions, are reported.	12 months
Secondary	Professional Care Team Burden Scale	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 months
Secondary	Days on sick leave of care staff	(as recorded monthly by the employer)	12 months

External Links

•   Project website