COVID-19, Mental Health Issue
Conditions
Keywords
Mindfulness, Meditation, Music
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.
Interventions
BEHAVIORALin person meditation
in person guided meditation
BEHAVIORALin person meditation using headphones
in person meditation using headphones
BEHAVIORALvirtual meditation
virtually guided meditation via Zoom
Sponsors
Yale University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Screening prior to the consent process will include assessing the age and relevant medical history of each prospective participant.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score Perceived Stress Scale | 8 weeks | The Perceived Stress Scale (PSS-10) is a 10-item, validated, self-report, questionnaire used to assess perceived control and confidence in managing stressful situations over the past month. Scores range from 0 to 40, with higher scores indicated higher levels of perceived stress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score Social Connectedness Scale | 8 weeks | The Social Connectedness Scale (SCS) is a self-report questionnaire that measures the extent to which individuals feel connected to others in their social environment. 20 items on a 6-point Likert scale, from 1 (strongly disagree) to 6 (strongly agree). Total score is achieved by summing all items with total score range from 20-120. Higher scores indicate a greater sense of social connectedness. |
Countries
United States
Contacts
CONTACTAZA Allsop, MD, PhD
PRINCIPAL_INVESTIGATORAZA Allsop, MD, PhD
Yale University
Outcome results
None listed