Meditation and Kundalini Yoga for Heightened Anxiety Related to COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Meditation and Yoga for Heightened Anxiety Related to COVID-19

Conditions
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Generalized Anxiety, Health Anxiety

Intervention / Treatment
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* Behavioral: Anxiety Reduction Training
* Behavioral: Kundalini Yoga and Anxiety Reduction Training
* Behavioral: Meditation and Anxiety Reduction Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to one of three treatment arms: Anxiety Reduction Training (A.R.T.), ART with Kundalini Yoga, ART with Meditation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anxiety Reduction Training (A.R.T.)<br>Participants will received biweekly on-line lessons that provide education and strategies to reduce stress and disturbing thoughts and improve healthy coping and sleep. . | Behavioral: Anxiety Reduction Training<br>* Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress.<br>|
| Experimental: ART and Kundalini Yoga<br>This combines ART with a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer. | Behavioral: Anxiety Reduction Training<br>* Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress.<br>Behavioral: Kundalini Yoga and Anxiety Reduction Training<br>* Daily practice of Kundalini Yoga (light stretching, breathing exercises, and meditation) guided by on-line video instruction, as well as the biweekly anxiety reduction psychoeducation.<br>|
| Experimental: ART and Meditation<br>This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. | Behavioral: Anxiety Reduction Training<br>* Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress.<br>Behavioral: Meditation and Anxiety Reduction Training<br>* Daily practice of meditation (muscle relaxation, breathing, and meditation) guided by on-line video instruction, as well as the biweekly anxiety reduction psychoeducation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GAD-7 | Generalized Anxiety Disorder 7-item scale (range 0-21, higher is worse) | Up to 32 weeks | 
| Whiteley 8 | Health Anxiety 8-item scale (range 0-32, higher is worse) | Up to 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-8 | Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher is worse) | Up to 32 weeks | 
| SS-8 | Somatic Symptom Scale-8 an 8-item measure of symptom burden (range 0-32, higher is worse) | Up to 32 weeks | 
| Applied Cognition 1.0 | An 8-item self-report measure of cognitive function (range 8-40, higher is worse) | Up to 32 weeks | 
| PROMIS-4 Sleep Disturbance | A 4-item self-report assessment of sleep disturbance (range 4-20, higher is worse) | Up to 32 weeks | 
| ERQ | Emotional Regulation Questionnaire - a 10-item measure of emotional regulation; the reappraisal subscale has a range: of 6-42, higher score is considered positive; while the suppression subscale has a range of 4-28, higher score considered negative. .. | Up to 32 weeks | 
| Perceived Stress Scale | A 10-item scale assessing the perception of events in one's life as stressful (0-40, higher represents higher perception of stress) | Up to 32 weeks | 
| Brief Hypervigilance Scale | A 5-item scale assessing hypervigilance (0-20, higher represents greater hypervigilance) | Up to 32 weeks |