Evaluating the Impact of Community-Based Mindfulness and Musical Programs on Psychiatric Measures, Music Mindfulness Study 2a.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Mean Score Perceived Stress Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •symptoms of anxiety or depression assessed by PHQ9 (>9) and GAD7 (>9)
排除标准
- •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
研究组 & 干预措施
In person with live music
Cohort 1 will be guided through in-person meditation. Participants in all cohorts will be asked to attend one of the weekly sessions offered twice a week for the entirety of the 8 weeks for at least 1 hour. Participants will also be given access and asked to listen to virtual music-backed mindfulness guided meditations to listen to between in- person sessions.
干预措施: in person meditation (Behavioral)
In person with headphones
Cohort 2 (also in-person) will experience this same meditation as Cohort 1 concurrently through headphones (in a space separate from Cohort 1). Participants in all cohorts will be asked to attend one of the weekly sessions offered twice a week for the entirety of the 8 weeks for at least 1 hour. Participants will also be given access and asked to listen to virtual music-backed mindfulness guided meditations to listen to between in- person sessions.
干预措施: in person meditation using headphones (Behavioral)
Virtual participation
Cohort 3 will be participating virtually by following along to the guided meditation via a password-protected Zoom room. Participants in all cohorts will be asked to attend one of the weekly sessions offered twice a week for the entirety of the 8 weeks for at least 1 hour. Participants will also be given access and asked to listen to virtual music-backed mindfulness guided meditations to listen to between in- person sessions.
干预措施: virtual meditation (Behavioral)
结局指标
主要结局
Mean Score Perceived Stress Scale
时间窗: 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.
次要结局
- Mean Score Social Connectedness Scale(8 weeks)