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临床试验/NCT04386291
NCT04386291Unknown不适用

Meditation and Yoga for Heightened Anxiety Related to COVID-19

Research Foundation for Mental Hygiene, Inc.2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2020年5月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
360
试验地点
2
主要终点
GAD-7

研究概览

简要总结

This randomized clinical on-line study examines whether whether a daily practice of meditation or Kundalini Yoga with anxiety reduction training leads to a greater reduction in anxiety than anxiety reduction training alone.

详细描述

The individual and societal costs of the COVID-19 pandemic are wide-ranging. Based on past epidemics and on emerging data, anxiety and depression rates will increase, along with anger, grief, somatic complaints, and post-traumatic stress. Coping skills will be challenged, particularly as anxiety, uncertainty, and personal loss increase.

While anxiety is a healthy response to danger, excessive anxiety can be debilitating and impair our coping skills. Illness anxiety may also increase given concerns about infection risks to self and others.

This randomized on-line study is for individuals with anxiety and distress triggered by COVID-19 who have not yet been infected with the novel corona virus. .

The primary study goal is to examine the extent to which anxiety can be reduced through the use of on-line training programs. All participants will receive Anxiety Reduction Training using cognitive-behavioral methods known to be helpful in reducing stress, anxiety, depression, and insomnia. In addition, two-thirds of participants will be randomly assigned to receive training in either Kundalini Yoga (KY) or mindfulness meditation. The investigators will assess the degree to which each of these training programs lead to reduced stress, improved well-being, decreased multisystem symptoms, enhanced mood, and reduced cognitive complaints. Participants will complete self-report assessments at 2-week intervals during the 8 weeks of the acute phase of the study and then again 3- and 6-months later.

The current study may reveal that addressing emergent anxiety early through online self-guided treatment approaches can lead to improved short- and long-term outcome. Findings from this study may reveal that these inexpensive easily disseminated on-line programs can be helpful to enhance coping and improve mental health in the context of large-scale public health crises.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Heightened anxiety triggered or exacerbated by COVID-19
  • Anxiety it least mild-moderate in severity
  • English speaking and living in the United States
  • Access to a smart phone, tablet, or computer with internet
  • Able to read and understand English

排除标准

  • Individuals with severe depression or substance abuse
  • Individuals with a current or past history of psychosis, bipolar disorder, or PTSD.
  • Individuals with physical disability that might make study participation difficult.
  • Individuals with an unstable medical illness or a history of cardiac disease
  • Individuals with a current daily practice of meditation or Kundalini yoga
  • Individuals with confirmed or suspected COVID-19
  • Individuals who are currently pregnant or anticipate being pregnant during study

结局指标

主要结局

GAD-7

时间窗: 8 weeks

Generalized Anxiety Disorder 7-item scale (range 0-21, higher score indicates more pronounced anxiety). A change score is calculated based on baseline score minus week 8 score.

Whiteley 8

时间窗: 8 weeks

Health Anxiety 8-item scale (range 0-32, higher score indicates more pronounced anxiety). A change score is calculated based on baseline score minus week 8 score.

次要结局

  • PHQ-8(8 weeks)
  • SS-8(8 weeks)
  • Applied Cognition 1.0(8 weeks)
  • PROMIS-4 Sleep Disturbance(8 weeks)
  • ERQ(8 weeks)
  • Perceived Stress Scale(8 weeks)
  • Brief Hypervigilance Scale(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian A Fallon

Professor of Psychiatry

Research Foundation for Mental Hygiene, Inc.

研究点 (2)

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