NCT06513871

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. Component 2d. Social Perception Tasks: Participants may be asked to take part in social perception tasks in which they will be asked to indicate their social perception and connection felt with various partners.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at 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

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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 (1)

  • Mean score individual subjective rating of social connection during session

    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 on day of study and 5 minutes after intervention

Secondary Outcomes (1)

  • Mean score group subjective rating of social connection post session

    baseline on day of study and 5 minutes after intervention

Study Arms (1)

Component 2d. Social Perception Tasks

EXPERIMENTAL

Participants will take part in social perception tasks in speed-dating like interactions with individuals in which they are not allowed to verbally communicate. After silently interacting with each partner, subjects will be prompted to answer survey questions about their perceptions of their partner and their interaction. This task will take place in a variety of settings.

Behavioral: Social perception tasks

Interventions

social perception tasks

Component 2d. Social Perception Tasks

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
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
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