DepressionNCT03922672
Piano Training, Caregivers, and Parkinson's Disease
A study testing Group piano training in people with Depression and Mood, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to investigate the impact of group piano training on psychosocial outcomes in caregivers of adults with Parkinson's disease (PD). As well, the study is investigating the impact of group piano training on psychosocial outcomes in the care-recipient with PD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Depression, Mood, Burden, Dependency
- What is being tested?
- Group piano training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 15 Aug 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregiver:
- Are currently a primary caregiver to an adult with PD
- Are between the age of 40-80 years
- Have less than 5 years of music training
- Speak and read English fluently
- Adult with PD:
Show all 10Show fewer
- Stage 1-3 Parkinson's disease
- Are between the age of 40-80
- Have less than 5 years of music training
- Speak and read English fluently
Who cannot join
- Doesn't meet all the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Group Piano Training on Psychosocial Outcomes in Caregivers of Adults With Parkinson's Disease
The purpose of this study is to investigate the impact of group piano training on psychosocial outcomes in caregivers of adults with Parkinson's disease (PD). As well, the study is investigating the impact of group piano training on psychosocial outcomes in the care-recipient with PD.
- Conditions
- Depression, Mood, Burden, Dependency
- Being tested
- Group piano training
- Keywords
- caregiver, Parkinson's disease, group piano training
- Medical subject headings
- Depression, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group piano trainingBehavioural
The group piano training is scheduled over 4 months of a two-hour weekly group piano lesson. There is also a 3-hour weekly practice at home.
| Study group | Role | What they receive |
|---|---|---|
| Piano group | Experimental | This group will consist of the adult with Parkinson's disease and their caregiver for a total of 14 pairs. Receives: Behavioral: Group piano training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregiver burden as assessed by the Zarit Burden Interview.
The Zarit burden is a 22-item questionnaire with range from 0-88 with a higher score indicating severe burden.
Measured: Baseline to month 1, baseline to month 2, baseline to month 4
Secondary outcomes (3)
Change in depression as assessed by the Center for Epidemiological Studies for Depression (CES-D).
The CES-D is a 20-item questionnaire with range from 0-60 with a higher score indicating increased symptoms of depression.
Measured: Baseline to month 1, baseline to month 2, baseline to month 4
Change in musical self-efficacy as assessed by the Musical Performance Self-Efficacy Scale (MPSE).
The MPSE is a 24 item questionnaire with range from 0-2400 with a higher score indicating improved musical self-efficacy.
Measured: Baseline to month 1, baseline to month 2, baseline to month 4
Change in mood by the Profile of Mood States - Brief Form (POMS-BF).
The POMS-BF is a 30 item questionnaire with six sub-scale scored on a 5-point Likert scale with a higher total score indicating increased negative mood.
Measured: From month 1 to month 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start22 Aug 2019
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Lesiuk, University of Miami
- Investigators
- Teresa L Lesiuk, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922672
- Sponsor's protocol ID
- 20180888
- Status last verified
- Aug 2021
- First submitted
- 17 Apr 2019
- Last updated
- 19 Aug 2021
- 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 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Group Piano Training on Psychosocial Outcomes in Caregivers of Adults With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03922672
- Acronym / sponsor ID
- 20180888
- Conditions
- Depression, Mood, Burden, Dependency
- Keywords
- caregiver, Parkinson's disease, group piano training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 22 Apr 2019 (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.
The purpose of this study is to investigate the impact of group piano training on psychosocial outcomes in caregivers of adults with Parkinson's disease (PD). As well, the study is investigating the impact of group piano training on psychosocial outcomes in the care-recipient with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Piano group | Experimental | Behavioral: Group piano trainingThis group will consist of the adult with Parkinson's disease and their caregiver for a total of 14 pairs. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Caregiver:
- Stage 1-3 Parkinson's disease
- Are between the age of 40-80
- Have less than 5 years of music training
- Speak and read English fluently
Key exclusion criteria (1 listed)
- Doesn't meet all the inclusion criteria
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 |
|---|---|---|
| Group piano trainingThe group piano training is scheduled over 4 months of a two-hour weekly group piano lesson. There is also a 3-hour weekly practice at home. | Behavioural | Piano group |
Primary outcome
Change in caregiver burden as assessed by the Zarit Burden Interview.
Time frame: Baseline to month 1, baseline to month 2, baseline to month 4
The Zarit burden is a 22-item questionnaire with range from 0-88 with a higher score indicating severe burden.
3 secondary outcomes
Change in depression as assessed by the Center for Epidemiological Studies for Depression (CES-D).
Time frame: Baseline to month 1, baseline to month 2, baseline to month 4
Change in musical self-efficacy as assessed by the Musical Performance Self-Efficacy Scale (MPSE).
Time frame: Baseline to month 1, baseline to month 2, baseline to month 4
Change in mood by the Profile of Mood States - Brief Form (POMS-BF).
Time frame: From month 1 to month 4.
Results and safety
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- 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.
Teresa L Lesiuk, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group piano training in people with Depression and Mood, run by University of Miami at 1 site in United States.
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 10 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: stopped early, as of the sponsor's last update on 19 Aug 2021. 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 States. 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 was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
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 in caregiver burden as assessed by the Zarit Burden Interview. (time frame: Baseline to month 1, baseline to month 2, baseline to month 4). 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 Aug 2021.