Meditation and Yoga for Heightened Anxiety Related to COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 256
- Locations
- 2
- Primary Endpoint
- GAD-7
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Anxiety Reduction Training (A.R.T.)
Participants will received biweekly on-line lessons that provide education and strategies to reduce stress and disturbing thoughts and improve healthy coping and sleep. .
Intervention: Anxiety Reduction Training (Behavioral)
ART and Kundalini Yoga
This combines ART with a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer.
Intervention: Anxiety Reduction Training (Behavioral)
ART and Kundalini Yoga
This combines ART with a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer.
Intervention: Kundalini Yoga and Anxiety Reduction Training (Behavioral)
ART and Meditation
This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing.
Intervention: Anxiety Reduction Training (Behavioral)
ART and Meditation
This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing.
Intervention: Meditation and Anxiety Reduction Training (Behavioral)
Outcomes
Primary Outcomes
GAD-7
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Brian A Fallon
Professor of Psychiatry
Research Foundation for Mental Hygiene, Inc.