- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06513910
Evaluating the Impact of Social Music
Evaluating the Impact of Community-Based Mindfulness and Musical Programs on Psychiatric Measures, Social Music Study 2b.
Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.
2b. Social Music Study: Investigators will assess the neural mechanisms of feelings of subjective connectedness during communal music listening and creating between dyads of subjects who are both familiar and unfamiliar with each other.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators also propose a study to investigate the effects of communal drumming in reducing anxiety and increasing connectedness within drum circle community. Investigators hypothesize that these intervention will lead to reductions in scores on stress scales and will provide preliminary data for studies evaluating these types of community programs as an adjunct to the standard of care.
Participants will be screened, consented, and enrolled in dyads in a paradigm in which they will be positioned across from each other while listening to various types of music (i.e. music that is harmonically-intact and music in which the harmonic content has been randomly scrambled).
Survey data will also be collected to assess variables such as musical experience, partner familiarity, perceived stress, etc.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: AZA Allsop, MD, PhD
- Phone Number: 240-422-3289
- Email: Aza.allsop@yale.edu
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06515
- Recruiting
- BLOOM
-
New Haven, Connecticut, United States, 06520
- Recruiting
- Musical Intervention Studios
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ages 16 and older
Exclusion Criteria:
- contraindications to functional Near Infrared Spectroscopy or Electroencephalography
- ages 15 and younger
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Component 2b. Social Music Study
Investigators will assess the neural mechanisms of feelings of subjective connectedness during communal music listening and creating between dyads of subjects who are both familiar and unfamiliar with each other
|
Participants in dyads will be positioned across from each other while listening to various types of music (i.e.
music that is harmonically-intact and music in which the harmonic content has been randomly scrambled).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG gamma and theta activity during music vs no music conditions
Time Frame: baseline measurements on day of study, during music vs no music conditions, and 30 minutes after music listening
|
EEG gamma and theta activity measured by the Post Spectral Density measures in the gamma range (>30Hz) and theta (4-8Hz) frequency ranges during music vs no music conditions.
|
baseline measurements on day of study, during music vs no music conditions, and 30 minutes after music listening
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean score subjective rating of social connection during session
Time Frame: baseline measurements on day of study, during music vs no music conditions, and 30 minutes after music listening
|
Rating of subjective connectedness will be assessed using a Likert scale with total score range from 1-5, with higher scores indicating more connectedness.
|
baseline measurements on day of study, during music vs no music conditions, and 30 minutes after music listening
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: AZA Allsop, MD, PhD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Therapeutics
- Complementary Therapies
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Music Therapy
Other Study ID Numbers
- 2000028866_b
- 2R25MH071584-11 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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