Clinical trial NCT06505226: Music Mindfulness Study 2a.
Official title: Evaluating the Impact of Community-Based Mindfulness and Musical Programs on Psychiatric Measures, Music Mindfulness Study 2a.
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: 2024-07-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Screening prior to the consent process will include assessing the age and relevant medical history of each prospective participant.
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.

Music Mindfulness Study: Investigators will compare the effects of music-backed guided mindfulness mediation and guided mediation alone in alleviating anxiety and depression.

Detailed description: Investigators hypothesize that this 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 into either a 2-week pilot study (to test the feasibility of the experiment) or an 8-week full length study. The focus of this registration is the 8-week full length study.

Upon completion of the study, participants will be asked to take part in a focus group that will provide valuable feedback on their experience with the mindfulness intervention.

Eligibility criteria: Inclusion Criteria:

* symptoms of anxiety or depression assessed by PHQ9 (\>9) and GAD7 (\>9)

Exclusion Criteria:

* Component 2a
* PHQ-9 \<9, GAD7 \< 9
* regular meditation practice of at least once a week
* has taken meditation course or intervention in the past year
* any hospitalizations in the last 6 months
* suicidal ideation, self-injurious behavior, or homicidal ideation at screening
* active audio-visual hallucinations or other signs of psychosis
* diagnosis of a seizure disorder or other neurological disorder that precludes outpatient participation
* history of thyroid or cardiovascular disease
* current substance use disorder

Primary outcomes:
measure: Mean Score Perceived Stress Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Mean Score Social Connectedness Scale
timeFrame: 8 weeks
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: