DementiaNCT03404050
Community Based Music and Dance Movement Therapy Group for Older Adults With Dementia
A study testing Music and dance movement therapy in people with Dementia, run by Edge Hill University at 1 site in United Kingdom.
Trial summary
This study explores the value of a particular community based music and dance movement therapy group for older adults with dementia? To answer this question, the investigators intend to address the following two sub-questions: 1. How does participants' use of music and movement change over time? 2. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Music and dance movement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2017to 12 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Over 65 years old
- Living in the community
- Diagnosis of dementia
- Adequate functional hearing/vision
- Sufficient knowledge of English to understand participant information sheet
Who cannot join
- Participants excluded if they suffered from any physical or psychological conditions that make it difficult to access a group setting independently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community Based Music and Dance Movement Therapy Group for Older Adults With Dementia
This study explores the value of a particular community based music and dance movement therapy group for older adults with dementia?
To answer this question, the investigators intend to address the following two sub-questions:
- How does participants' use of music and movement change over time?
- Did a music and dance movement therapy group improve participants' depressive symptoms?
Read the detailed description
A systematic review identified a need to explore the value of an arts therapies group for older adults with dementia living in the community with early to moderate stage dementia. This client population commonly experience depression, social withdrawal and cognitive difficulties and literature suggests a music and dance movement therapy group could potentially make a contribution to both reducing symptoms and improving communication and wellbeing. However, there is still lack of clarity on clinically meaningful outcome measures, detail regarding the therapeutic process and questions remain regarding the trustworthiness of qualitative observations. This mixed method feasibility study aims to test whether the interventions translate to a community setting, provide richer insight into the meaningful aspect of the therapeutic process and provide some preliminary quantitative findings.
- Conditions
- Dementia
- Being tested
- Music and dance movement therapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music and dance movement therapyOther
Theoretically, the intervention adopts a humanistic approach of person centred care highlighting the importance of maintaining and enhancing personhood for older people with dementia.
| Study group | Role | What they receive |
|---|---|---|
| Music and dance movement therapy group | Experimental | Music and dance movement therapy group Receives: Other: Music and dance movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cornell Scale for Depression in Dementia
Joint interview with participant and care provider/family member regarding signs and symptoms of depression; a score greater than 10 indicates probably major depressive episode
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start13 Jun 2017
- Primary completion12 Sep 2017
- Study completion12 Sep 2017
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Assessments taken at three different time periods: week zero, week five and week eleven.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edge Hill University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vicky Karkou, Study director, Edge Hill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404050
- Sponsor's protocol ID
- SL PhD
- Status last verified
- Jan 2018
- First submitted
- 9 Jan 2018
- Last updated
- 19 Jan 2018
- 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 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Based Music and Dance Movement Therapy Group for Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT03404050
- Acronym / sponsor ID
- SL PhD
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Edge Hill UniversityUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 19 Jan 2018 (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.
This study explores the value of a particular community based music and dance movement therapy group for older adults with dementia?
To answer this question, the investigators intend to address the following two sub-questions:
- How does participants' use of music and movement change over time?
- Did a music and dance movement therapy group improve participants' depressive symptoms?
Detailed description
A systematic review identified a need to explore the value of an arts therapies group for older adults with dementia living in the community with early to moderate stage dementia. This client population commonly experience depression, social withdrawal and cognitive difficulties and literature suggests a music and dance movement therapy group could potentially make a contribution to both reducing symptoms and improving communication and wellbeing. However, there is still lack of clarity on clinically meaningful outcome measures, detail regarding the therapeutic process and questions remain regarding the trustworthiness of qualitative observations. This mixed method feasibility study aims to test whether the interventions translate to a community setting, provide richer insight into the meaningful aspect of the therapeutic process and provide some preliminary quantitative findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assessments taken at three different time periods: week zero, week five and week eleven.
| Arm | Type | Receives |
|---|---|---|
| Music and dance movement therapy group | Experimental | Other: Music and dance movement therapyMusic and dance movement therapy group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Over 65 years old
- Living in the community
- Diagnosis of dementia
- Adequate functional hearing/vision
- Sufficient knowledge of English to understand participant information sheet
Key exclusion criteria (1 listed)
- Participants excluded if they suffered from any physical or psychological conditions that make it difficult to access a group setting independently.
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 |
|---|---|---|
| Music and dance movement therapyTheoretically, the intervention adopts a humanistic approach of person centred care highlighting the importance of maintaining and enhancing personhood for older people with dementia. | Other | Music and dance movement therapy group |
Primary outcome
Cornell Scale for Depression in Dementia
Time frame: 7 days
Joint interview with participant and care provider/family member regarding signs and symptoms of depression; a score greater than 10 indicates probably major depressive episode
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Registered systematic review protocolLink provided by the sponsor.
- 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.
Vicky Karkou study director
Edge Hill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and dance movement therapy in people with Dementia, run by Edge Hill University at 1 site in United Kingdom.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 19 Jan 2018. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cornell Scale for Depression in Dementia (time frame: 7 days). 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 19 Jan 2018.