Clinical trial NCT06513910: Evaluating the Impact of Social Music
Official title: Evaluating the Impact of Community-Based Mindfulness and Musical Programs on Psychiatric Measures, Social Music Study 2b.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
COVID-19
Keywords: Mindfulness
Meditation
Music
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-07-22
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be screened, consented, and enrolled in dyads.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* ages 16 and older

Exclusion Criteria:

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

Primary outcomes:
measure: EEG gamma and theta activity during music vs no music conditions
timeFrame: baseline measurements on day of study, during music vs no music conditions, and 30 minutes after music listening
Secondary outcomes:
measure: Mean score subjective rating of social connection during session
timeFrame: baseline measurements on day of study, during music vs no music conditions, and 30 minutes after music listening
Other outcomes:
Locations:
city: New Haven
country: United States
facility: BLOOM
state: Connecticut
city: New Haven
country: United States
facility: Musical Intervention Studios
state: Connecticut
Study officials:
affiliation: Yale University
name: AZA Allsop, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: