- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07693114
Support in Sound: Music Therapy for People Living With Dementia and Companions in Rural Communities
The Support in Sound Music Therapy Research Project for People Living With Dementia and Companions in Rural Communities
The goal of this single-arm feasibility study is to learn whether group music therapy is feasible in a rural area for people living with dementia and their companions. The main questions are:
- Is a group music therapy intervention feasible in a rural community setting? 1a. Are there preliminary changes in health and well-being outcomes following participation in a 10-week community music therapy group?
- What were participants' experiences and preferences regarding the different components of the music therapy programme?
- What is the role of peer support in participants' experiences of a community music therapy intervention?
Participants living with dementia and their companions will be asked to take part in 10-weeks of music therapy in the community. Before and after each music therapy session, they will be asked to answer an easy-read satisfaction survey to gather information on the 'in the moment' experiences of music therapy.
Participants will also be asked to complete surveys on quality of life, loneliness, depression and well-being on three occasions:
- Before music therapy starts
- During week 5 of music therapy
- After music therapy
After music therapy, participants will also be asked to
- Complete a survey about their experiences of different parts of the music therapy programme
- Take part in an individual feasibility interview
- Take part in an interview exploring the role of peer support within the music therapy groups
If a person does not have the capacity to answer any questions, their companion will be asked to provide the information on behalf of the individual living with dementia.
Přehled studie
Detailní popis
Support in Sound is a 14-week research project for people living with dementia and their carers in Tarporley and the surrounding villages. The project explores how community-based group music therapy may support quality of life, social connection, depression and well-being for participants.
Research suggests that music therapy can have positive emotional and social benefits for people living with dementia. A study found that group music therapy significantly reduced anxiety and depression compared to usual care, with improvements still present three months later, suggesting possible longer-term mental health benefits. A Cochrane review also found that music-based therapeutic interventions may improve social behaviour, depressive symptoms, and overall behavioural symptoms in people with dementia. In addition, music therapy may help facilitate positive emotions and strengthen connections with significant others.
However, less is known about the practicalities, accessibility, and acceptability of delivering group music therapy in rural communities. People living in rural areas may have fewer opportunities to access support groups, wellbeing activities and meet with peers than those living in towns and cities. There is also limited research exploring the role of peer support and shared social experiences within group music therapy for people living with dementia and their carers.
Participants will be recruited from Tarporley and the surrounding villages in line with supporting the health and well-being of local residents living with dementia and their companions in the community. Recruitment posters will be advertised around the village and circulated with care groups in the area. Consent will be obtained from caregivers and individuals living with dementia if they have capacity to do so. Where a person does not have capacity, a consultee will complete a declaration form on behalf of the person living with dementia. Demographic data will be collected before the study commences.
The project consists of 2 weeks for baseline data collection, 10-weeks of group music therapy including data collection during week 5 and 2 weeks of data collection at the end of the study.
The music therapy will be delivered by a HCPC registered music therapist with experience of working with people living with dementia. The sessions will include singing, listening to music, playing with instruments and using music to enable social engagement. Sessions will include an opportunity for peers to socialise over tea, coffee and cake before and after each music therapy session. The team aims to recruit between 6 - 7 dyads.
Feasibility data will be collected to understand the practicality and acceptability of the study using the following data:
- Recruitment rates: Monitoring the number of people recruited
- Retention data: Monitoring the number of people who completed the study
- Adherence rates: Marking an online register each time a person attends a session
- Collecting current mood before and after each music therapy session and satisfaction at the end of each session
- An end of study feasibility interview with participants focused on the implementation, mechanisms of impact and context.
The potential preliminary changes in health and well-being of both persons living with dementia and their companions will be measured using the following data:
- Quality of life - DEMQOL and DEMQOL Proxy
- Loneliness - UCL Loneliness 3-point scale
- Depression - Short Geriatric Depression Scale
- Well-being - Short Warwick-Edinburgh Mental Wellbeing Scale
All participants will be asked to complete each of the outcome measures before music therapy, during week 5 of music therapy and at the end of music therapy to measure potential changes during the course of participating in music therapy.
Additional information will be requested to:
- Learn about the perceived satisfaction and value of each of the components of the music therapy programme. This data will be conducted using a survey designed on Microsoft Forms
- Learn about the potential role of peer support within the music therapy programme using a semi-structured interview guide.
Descriptive data will be analysed and there will be a repeated measures analysis. Interview data will be analysed qualitatively.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Kiera Kenny, PhD
- Telefonní číslo: +447979154869
- E-mail: kk79@aru.ac.uk
Studijní místa
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Chester, Spojené království
- Tarporley Community Centre
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Kontakt:
- Kiera Kenny
- Telefonní číslo: +447979154869
- E-mail: kk79@aru.ac.uk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- One person must have a clinical diagnosis of dementia and be accompanied by a companion
- Participants must be able to attend the 10-week programme, recognising that unavoidable absences (e.g., illness or unforeseen personal circumstances) may occur
- Be willing to provide data on health and well-being and take part in interviews.
- Be able to speak and understand the English language
Exclusion Criteria:
- Individuals, as dyads are the participants being recruited
- Dyads were neither person has a clinical diagnosis of dementia
- Are unavailable to generally commit to the research programme including music therapy sessions
- Are unable to speak or understand the English language
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Music therapy group
Group music therapy will be delivered to participants for 10-weeks.
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Group music therapy will be held in the local community of Tarporley for 10 weeks.
The music therapy will be delivered by a HCPC registered music therapist with experience of working with people living with dementia.
Each session will be held for 1.5 hours: consisting of 1 hour of music therapy and the remaining time available for participants to have tea, coffee and cake providing an opportunity to talk and socialise.
All participants will be provided with a name label before each session.
The one hour of weekly music therapy will consist of singing, music listening, playing with instruments and interactive music making opportunities.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Acceptability and practicality of the study
Časové okno: From enrolment to the end of the 14-week research programme
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The following feasibility measures will be collected to assess the acceptability and practicality of the study: number of participants who were recruited, adhered and retained to the study.
Numerical levels of satisfaction throughout the duration of the study and qualitative details on feasibility from participants.
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From enrolment to the end of the 14-week research programme
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Dementia quality of life measure: DEMQOL
Časové okno: Up to two weeks before the music therapy programme starts, again at week 5 and up to two weeks after music therapy programme.
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Quality of life of participants living with dementia will be measured using the DEMQOL questionnaire or the DEMQOL proxy questionnaire completed by their companion if a person does not have capacity to answer for themselves. Scoring: DEMQOL: (minimum score) 28-112 (maximum score); higher score = better quality of life. DEMQOL-Proxy: (minimum score) 31-124 (maximum score); higher =better quality of life as rated by a caregiver/proxy). |
Up to two weeks before the music therapy programme starts, again at week 5 and up to two weeks after music therapy programme.
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UCLA 3-item Loneliness Scale
Časové okno: Up to two weeks before the music therapy programme starts, again at week 5 and up to two weeks after music therapy programme.
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Loneliness will be measured of both participants living with dementia and their companions using the UCLA 3-item Loneliness Scale. If a person does not have capacity, their companion will complete this on behalf of the person living with dementia. Scoring: 3 (minimum score) - 9 (maximum score) with higher scores indicating greater loneliness. |
Up to two weeks before the music therapy programme starts, again at week 5 and up to two weeks after music therapy programme.
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Short Geriatric Depression Scale (GDS 15)
Časové okno: Up to two weeks before the music therapy programme starts, again at week 5 and up to two weeks after music therapy programme.
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Depression levels will be measured using the Short Geriatric Depression Scale for both individuals living with dementia and their companions for those over 65 years of age. If a person does not have capacity, their companion will complete this on behalf of the person living with dementia. Scoring: 0 (minimum score) - 15 (maximum score) with higher scores indicating worse depressive symptoms |
Up to two weeks before the music therapy programme starts, again at week 5 and up to two weeks after music therapy programme.
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Short Warwick-Edinburgh Mental Wellbeing Scale
Časové okno: Up to two weeks before the music therapy programme starts, again at week 5 and up to two weeks after music therapy programme.
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Well-being will be measured using the Short Warwick-Edinburgh Mental Wellbeing Scale for both person living with dementia and their companions. If a person does not have capacity, their companion will complete this on behalf of the person living with dementia. Scoring: 7 (minimum score) - 35 (maximum score) with higher scores indicating better well-being. |
Up to two weeks before the music therapy programme starts, again at week 5 and up to two weeks after music therapy programme.
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Hussain B, Mirza M, Baines R, Burns L, Stevens S, Asthana S, Chatterjee A. Loneliness and social networks of older adults in rural communities: a narrative synthesis systematic review. Front Public Health. 2023 May 15;11:1113864. doi: 10.3389/fpubh.2023.1113864. eCollection 2023.
- Madso KG, Molde H, Hynninen KM, Nordhus IH. Observing Music Therapy in Dementia: Repeated Single-case Studies Assessing Well-being and Sociable Interaction. Clin Gerontol. 2022 Jul-Sep;45(4):968-982. doi: 10.1080/07317115.2021.1978121. Epub 2021 Sep 29.
- van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.
- Feng X, Dang W, Apuke OD. How does group music therapy help in combating the anxiety and depression of dementia patients? A quasi-experimental investigation. Arch Psychiatr Nurs. 2024 Oct;52:83-88. doi: 10.1016/j.apnu.2024.07.010. Epub 2024 Jul 8.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 373716
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- PROTOKOL STUDY
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