- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03922672
Piano Training, Caregivers, and Parkinson's Disease
August 13, 2021 updated by: Teresa Lesiuk, University of Miami
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33146
- University of Miami
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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:
- 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
Exclusion Criteria:
- Doesn't meet all the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Piano group
This group will consist of the adult with Parkinson's disease and their caregiver for a total of 14 pairs.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to month 1, baseline to month 2, baseline to month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
The CES-D is a 20-item questionnaire with range from 0-60 with a higher score indicating increased symptoms of depression.
|
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
|
The MPSE is a 24 item questionnaire with range from 0-2400 with a higher score indicating improved musical self-efficacy.
|
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.
|
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.
|
From month 1 to month 4.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Teresa L Lesiuk, PhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 22, 2019
Primary Completion (ACTUAL)
August 15, 2020
Study Completion (ACTUAL)
August 15, 2020
Study Registration Dates
First Submitted
April 17, 2019
First Submitted That Met QC Criteria
April 17, 2019
First Posted (ACTUAL)
April 22, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 19, 2021
Last Update Submitted That Met QC Criteria
August 13, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20180888
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
Bekelu Teka WorkuJimma UniversityNot yet recruitingPrenatal Depression | Mental Health Related Quality of Life | Maternal Postpartum Depression | Paternal Postpartum DepressionEthiopia
Clinical Trials on Group piano training
-
Westminster CollegeCompletedAging | Manual Dexterity | Piano TherapyUnited States
-
Recep Tayyip Erdogan University Training and Research...CompletedDental Anxiety in ChildrenTurkey (Türkiye)
-
University of GeorgiaApplied Universal Dynamics, Corp.; Van Robotics, Inc.Active, not recruitingRobot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI) (MCI)Cognitive Change | Aging | Cognitive Impairment, MildUnited States
-
University of South FloridaCompleted
-
Reuth Rehabilitation HospitalUniversity of HaifaRecruitingHemiparesis;Poststroke/CVAIsrael
-
University of MiamiCompletedBreast Cancer | Chemotherapy-Related Cognitive ImpairmentUnited States
-
Tel Aviv UniversitySheba Medical CenterSuspendedParkinson DiseaseIsrael
-
University of RochesterEastman Performing Arts Medicine Center; University of Rochester Aging Institute and other collaboratorsCompletedMild Cognitive Impairment (MCI) | Memory Decline | Memory Disorders, Age RelatedUnited States
-
University of California, San FranciscoNational Institute on Aging (NIA)CompletedCognitive Impairment | Aging | Mild Cognitive Impairment | Cognitive Training | Cognitive Aging | Cognitively Normal Older AdultsUnited States
-
The Mind Research NetworkUniversity of New MexicoRecruitingFetal Alcohol Spectrum DisordersUnited States