Evaluating the Impact of Social Music

NCT06513910 | Recruiting

• 2 other identifiers: 2000028866_b2R25MH071584-11
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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. 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.

Conditions

COVID-19; Mental Health Issue

Keywords

Mindfulness; Meditation; Music

Outcome Measures

Primary Outcomes (1)

• EEG gamma and theta activity during music vs no music conditions

  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 Outcomes (1)

• Mean score subjective rating of social connection during session

  baseline measurements on day of study, during music vs no music conditions, and 30 minutes after music listening

Study Arms (1)

Component 2b. Social Music Study

EXPERIMENTAL

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

Behavioral: Music

Interventions

Music BEHAVIORAL

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).

Component 2b. Social Music Study

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 16 and older

You may not qualify if:

• contraindications to functional Near Infrared Spectroscopy or Electroencephalography
• ages 15 and younger

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

BLOOM

New Haven, Connecticut, 06515, United States

RECRUITING

Musical Intervention Studios

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• AZA Allsop, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AZA Allsop, MD, PhD

CONTACT

240-422-3289; Aza.allsop@yale.edu

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

Model Details: Participants will be screened, consented, and enrolled in dyads.

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

Locations

US (2)