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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress.
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.
Daily practice of meditation (muscle relaxation, breathing, and meditation) guided by on-line video instruction, as well as the biweekly anxiety reduction psychoeducation.
ProofPilot (Virtual Study: https://proofpilot.com/covid-anxiety/)
New York, New York, United States
Columbia University Department of Psychiatry
New York, New York, United States
GAD-7
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.
Time frame: 8 weeks
Whiteley 8
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.
Time frame: 8 weeks
PHQ-8
Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher score indicates more pronounced depression). A change score is calculated based on baseline score minus week 8 score.
Time frame: 8 weeks
SS-8
Somatic Symptom Scale-8 an 8-item measure of symptom burden (range 0-32, higher score represents worsening of somatic symptoms). A change score is calculated based on baseline score minus week 8 score.
Time frame: 8 weeks
Applied Cognition 1.0
An 8-item self-report measure of cognitive function (range 8-40, higher is better). A change score is calculated based on baseline score minus week 8 score.
Time frame: 8 weeks
PROMIS-4 Sleep Disturbance
A 4-item self-report assessment of sleep disturbance (range 4-20, higher score indicates more sleep disturbance). A change score is calculated based on baseline score minus week 8 score.
Time frame: 8 weeks
ERQ
Emotional Regulation Questionnaire - a 10-item measure of emotional regulation; the reappraisal subscale has a range: of 6-42, higher score reflects improvement; while the suppression subscale has a range of 4-28, higher score considered worsening status. A change score is calculated based on baseline score minus week 8 score.
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Time frame: 8 weeks
Perceived Stress Scale
A 10-item scale assessing the perception of events in one's life as stressful (0-40, higher score indicates more pronounced perception of stress).A change score is calculated based on baseline score minus week 8 score.
Time frame: 8 weeks
Brief Hypervigilance Scale
A 5-item scale assessing hypervigilance (0-20, higher score indicates greater hypervigilance). A change score is calculated based on baseline score minus week 8 score.
Time frame: 8 weeks