NCT06513858

Brief Summary

Mental health vulnerability due to stress is increased America due to disproportionate effects of social factors such as 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 Persons of African Descent(PAD) 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 community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19. Component 2c. Drum Circle Study: Investigators will study the impact of participation in drum circles on anxiety and feelings of connectedness.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 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 12, 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 (1)

  • Rating of Absorption in music pre vs post sessions

    These ratings are classified on a scale from 0 to 1, with 0 indicating no absorption and 1 indicating complete absorption.

    Baseline on day of study visit before drum circle, during drum circle (45min), 30 min after music listening

Secondary Outcomes (1)

  • Altered States of Consciousness Rating Scale

    Baseline on day of study visit before drum circle, during drum circle (45min), 30 min after music listening

Study Arms (2)

Drum Circle- Cohort 1

EXPERIMENTAL

Cohort 1 will listen together to recordings of drumming and be allowed to drum along while listening. The facilitator will lead participants in procedures such as checking in (e.g. "How are you doing today?" before and after the circle) and breathing exercise.

Behavioral: Communal DrummingBehavioral: Communal drumming recordings

Drum Circle Control Group- Cohort 2

ACTIVE COMPARATOR

Control investigations will also be conducted to better understand the contribution communal drumming has on effects of anxiety and connectedness. All control investigations will take place in the same space and at the same frequency as the associated experimental arm but with no drumming. All participants will be asked to complete the same surveys and at the same frequency to those completed in the experimental arm.

Behavioral: Communal drumming recordings

Interventions

Communal drumming

Drum Circle- Cohort 1

Recordings of drumming taken from the music made during a previous component of the study

Drum Circle Control Group- Cohort 2Drum Circle- Cohort 1

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ages 16 and older

You may not qualify if:

  • ages 15 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
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 12, 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