NCT06513845

Brief Summary

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. 2c.a. Drum Circle Synchrony Study: This study will investigate the role that synchrony plays in subjective feelings of connection.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

July 10, 2024

Last Update Submit

February 10, 2026

Conditions

Keywords

MindfulnessMeditationMusic

Outcome Measures

Primary Outcomes (2)

  • Mean score connectedness rating

    Mean connectedness rating survey assessed using a Likert scale total range of 1 (no connection) to 7 (maximum connection) for synchronous and asynchronous audio samples

    measured during listening session (30minutes)

  • Mean score subjective rating of synchrony

    Subjective ratings of synchrony will be assessed using a Likert scale with total score range from 1-5, with higher scores indicating more synchrony, for synchronous and asynchronous audio samples.

    measured during listening session (30minutes)

Study Arms (2)

Musicians group

EXPERIMENTAL

Musicians will listen to segments (\~30 sec duration) of recordings taken from the music made during the previous drum circle and answer a survey asking how connected they felt while listening.Segments will be categorized as highly synchronized or not synchronized.

Behavioral: Communal drumming recordings

Non-musicians group

EXPERIMENTAL

Non-musicians will listen to segments (\~30 sec duration) of recordings taken from the music made during the previous drum circle and answer a survey asking how connected they felt while listening.Segments will be categorized as highly synchronized or not synchronized..

Behavioral: Communal drumming recordings

Interventions

Segments (\~30 sec duration) of recordings taken from the music made during the previous drum circle. Segments will be categorized as highly synchronized

Musicians groupNon-musicians group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages 18 and older

You may not qualify if:

  • ages 17 and younger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BLOOM

New Haven, Connecticut, 06515, United States

Location

Musical Intervention Studios

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • AZA Allsop, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 22, 2024

Study Start

August 1, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified, aggregate data will be shared through pre-prints, publications, and community town hall meetings.

Locations