Dementia Choirs for Social and Psychological Wellbeing

NCT07011498 | Active Not Recruiting

• 1 other identifier: 828898
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Loneliness is common in both persons living with dementia and their informal caregivers, and a factor negatively affecting disease progression, health and wellbeing. However, intervention studies to address loneliness show inconsistent effects. This study aims to evaluate effect of a community-based group intervention - music therapy informed dementia choirs - on loneliness for home-dwelling people with dementia and their informal caregivers. We will recruit participants to five dementia choirs with 15-20 people in each and implement a crossover study with measures collected at four timepoints: baseline, 12-week follow up, 22-week follow-up after an extended summer holiday, and 12-week follow-up after the summer holiday. The primary outcome, loneliness in participants living with dementia, will be measured using the De Jong Gierveld loneliness scale. Secondary outcomes will be depression, experience of meaning in life, apathy and mood for the participants living with dementia, and loneliness and caregiver burden for the informal caregivers. Cognition in the participants living with dementia, measured with the RUDAS assessment tool, will be included as a control variable. Further, measurements to evaluate the cost effectiveness of the choir intervention will be included, and qualitative data collected through semi-structured interviews to explore the experiences and possible impacts of the choir intervention in the participants' lives.

Conditions

Dementia; Informal Caregivers (Family and Friends)

Keywords

Dementia; Choir; Loneliness; Music therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in degree of loneliness in participants with dementia at 12 weeks (primary), 22 weeks and 36 weeks follow up

  Measured by the standardised questionnaire the De Jong Gierveld 6-item Loneliness Scale

  From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.

Secondary Outcomes (6)

• Change from baseline in degree of depression in participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up

  From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.

• Change from baseline in degree of self-reported meaning in life in participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up

  From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.

• Change from baseline in degree of apathy in participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up

  From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.

• Change from baseline in degree of loneliness in informal caregivers of participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up

  From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.

• Change from baseline in degree of caregiver burden to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.

  From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.

Other Outcomes (9)

• Change from baseline in cognition of participants with dementia to 12-week and 36-week follow up

  Entire intervention period comprising three measurements (baseline, 12-week follow-up, and final 12-week follow-up after an extended summer holiday)

• Caregiver experience of choirs as a relief or a burden

  At 36-week follow-up and during prolonged intervention after quantitative assessments

• Change from baseline in Quality of life in participants with dementia, Quality-adjusted life-years to 12-week follow up

  From baseline to 12-week follow up

Study Arms (1)

Dementia choir

EXPERIMENTAL

Other: Dementia choir

Interventions

Dementia choir OTHER

Music therapy informed dementia choirs will be delivered once a week. Rehearsals last app. 2 hours, including a social break. Each choir will be led by 1 conductor and 1 accompanist. The choir leaders will have relevant professional qualifications that supplement each other, such as a music therapist, music pedagogue, conductor, singer, singing teacher, or health care professional with additional music competence. They will be trained by the research team to deliver the choirs in a dementia friendly and music therapy informed way. In addition, the choir leaders will receive supervision from the research team throughout the intervention periods. The choirs will involve volunteers to assist during rehearsals and breaks. The volunteers will also receive training on how to support the choir participants in a dementia friendly way.

Also known as: choir, singing, music therapy

Dementia choir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dementia diagnosis (Alzheimers, Lewy-body, fronto-temporal, vascular, mixed, Parkinson's dementia) or cognitive impairment as reported by the person themselves/their caregiver
• Informal caregiver of participant with dementia: A person who has a close relationship with a recruited choir participant living with dementia. A close relationship may for instance be a spouse/partner, sibling, adult child, friend, niece or nephew
• Living at home in the community

You may not qualify if:

• Significant hearing impairment that is not resolved through the use of a hearing aid device and limit their capacity to enjoy musical experiences.
• Formal (paid) caregiver of participant with dementia

Sponsors & Collaborators

• Norwegian Academy of Music: lead
• Oslo Municipality: collaborator
• University of Oslo: collaborator
• Institute of Clinical Medicine, University of Oslo: collaborator

Study Sites (1)

Norwegian Academy of Music, Oslo

Oslo, Oslo County, 0302, Norway

Location

MeSH Terms

Conditions

Dementia

Interventions

Singing; Music Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phonation; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kjersti Johansson, PhD

  Norwegian Academy of Music

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study has a single group model in a crossover design. In the study, participants will be recruited to participate in dementia choirs. The choirs will be divided into two groups. Participants in each group will complete all assessments at the same timepoints but receive choir activity at different times.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: June 8, 2025
• Study Start: March 3, 2025
• Primary Completion: December 15, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)