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

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ClinicalTrials.gov Identifier: NCT03496675
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
University of Melbourne
Information provided by (Responsible Party):
NORCE Norwegian Research Centre AS

Brief 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.

Condition or disease Intervention/treatment Phase
Dementia Depression Behavioral: Group Music Therapy Behavioral: Recreational Choir Singing Other: Standard care Not Applicable

Detailed 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 six European countries, and a total of 100 care home units will be randomised to one of the four study conditions.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: 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
Official Title: Music Interventions for Dementia and Depression in Elderly Care: International Cluster-randomised Controlled Trial
Actual Study Start Date : July 18, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Standard care
Participants receive standard care as locally available. The components of standard care are recorded.
Other: Standard care
May include pharmacological and non-pharmacological interventions as locally available

Experimental: Group Music Therapy (GMT)

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).

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.

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

Experimental: Recreational Choir Singing (RCS)

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).

Behavioral: 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

Experimental: GMT + RCS
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.
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.

Behavioral: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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).

  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • resident (full-time, 24h/day) at a participating care home;
  • dementia as indicated by a Clinical Dementia Rating score of 0.5 to 2 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496675


Contacts
Contact: Monika Geretsegger, PhD (+47) 46928297 monika.geretsegger@uni.no
Contact: Christian Gold, PhD (+47) 46928297 christian.gold@uni.no

Locations
Australia, Victoria
The University of Melbourne Recruiting
Melbourne, Victoria, Australia, 3010
Contact: Felicity A Baker, PhD         
Sponsors and Collaborators
NORCE Norwegian Research Centre AS
University of Melbourne
Investigators
Principal Investigator: Christian Gold, PhD GAMUT, Uni Research Health, Bergen, Norway

Additional Information:
Responsible Party: NORCE Norwegian Research Centre AS
ClinicalTrials.gov Identifier: NCT03496675     History of Changes
Other Study ID Numbers: MIDDEL
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified datasets (participant codes and outcome scores) generated during and/or analysed during the current study will be stored in a publically available repository (NSD - Norwegian Centre for Research Data, http://www.nsd.uib.no/nsd/english/index.html).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data will become available upon publication of the primary outcome.
Access Criteria: De-identified IPD will be publicly available at the Norwegian Centre for Research Data (http://www.nsd.uib.no/nsd/english/index.html).

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Dementia
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders