Music Mindfulness Study 2a.

Официальное название

Evaluating the Impact of Community-Based Mindfulness and Musical Programs on Psychiatric Measures, Music Mindfulness Study 2a.

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое in person meditation
  in person guided meditation
• Поведенческое in person meditation using headphones
  in person meditation using headphones
• Поведенческое virtual meditation
  virtually guided meditation via Zoom

Первичные конечные точки

• Mean Score Perceived Stress Scale [Срок оценки: 8 weeks]

Вторичные конечные точки (1)

• Mean Score Social Connectedness Scale [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• BLOOM — New Haven
• Musical Intervention Studios — New Haven

Идентификаторы

NCT: NCT06505226 · 2000028866_a · 2R25MH071584-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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