DementiaNCT07011498
Dementia Choirs for Social and Psychological Wellbeing
A study testing Dementia choir in people with Dementia and Informal Caregivers (Family and Friends), run by Norwegian Academy of Music at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Informal Caregivers (Family and Friends)
- What is being tested?
- Dementia choir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 3 Mar 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Connecting Through Choir Singing: Dementia Choirs to Reduce Loneliness in Home-dwelling Persons Living With Dementia and Their Caregivers - a Crossover Study
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)
- Being tested
- Dementia choir
- Keywords
- Dementia, Choir, Loneliness, Music therapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia choirOther
Also called choir, singing, music therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Dementia choir | Experimental | Not described Receives: Other: Dementia choir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured by the standardised questionnaire Geriatric Depression Scale Short-Version, GDS-15.
Measured: 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
Measured by the standardised questionnaire The Meaning in Life Questionnaire Short Form (MLQ-SF)
Measured: 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
Measured by the standardised questionnaire Apathy Evaluation Scale - Informant Version, reported by informal caregivers as proxy.
Measured: 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
Measured by the standardised questionnaire The De Jong Gierveld 6-item Loneliness Scale measuring degree of self-reported loneliness.
Measured: 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.
Measured by the standardised self-reported questionnaire Relative's Stress Scale (RSS)
Measured: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.
Change of mood in participant with dementia from before to after choir rehearsals
Measured by tha standardised questionnaire The Dementia Mood Picture Test completed immediately before and after selected choir rehearsals (rehearsal 2, 6 and 11).
Measured: From before to after rehearsals for rehearsals 2, 6 and 11 (per choir).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start3 Mar 2025
- Primary completion15 Dec 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Academy of Music
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Municipality, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Kjersti Johansson, PhD, Principal investigator, Norwegian Academy of Music
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011498
- Sponsor's protocol ID
- 828898
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Through Choir Singing: Dementia Choirs to Reduce Loneliness in Home-dwelling Persons Living With Dementia and Their Caregivers - a Crossover Study
- ClinicalTrials.gov ID
- NCT07011498
- Acronym / sponsor ID
- 828898
- Conditions
- Dementia, Informal Caregivers (Family and Friends)
- Keywords
- Dementia, Choir, Loneliness, Music therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Norwegian Academy of MusicUniversity, hospital or other
- Collaborators
- Oslo Municipality, University of Oslo
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dementia choir | Experimental | Other: Dementia choir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dementia choirAlso: choir, singing, music therapyMusic 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. | Other | Dementia choir |
Primary outcome
Change from baseline in degree of loneliness in participants with dementia at 12 weeks (primary), 22 weeks and 36 weeks follow up
Time frame: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.
Measured by the standardised questionnaire the De Jong Gierveld 6-item Loneliness Scale
6 secondary outcomes
Change from baseline in degree of depression in participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.
Change of mood in participant with dementia from before to after choir rehearsals
Time frame: From before to after rehearsals for rehearsals 2, 6 and 11 (per choir).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjersti Johansson, PhD principal investigator
Norwegian Academy of Music
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia choir in people with Dementia and Informal Caregivers (Family and Friends), run by Norwegian Academy of Music at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in degree of loneliness in participants with dementia at 12 weeks (primary), 22 weeks and 36 weeks follow up (time frame: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.