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

Sponsor

Research Foundation for Mental Hygiene, Inc. (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04386291

Collaborator

(none)

360

Enrollment

Locations

Arms

20.2

Anticipated Duration (Months)

180

Patients Per Site

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Generalized Anxiety Health Anxiety	Behavioral: Anxiety Reduction Training Behavioral: Kundalini Yoga and Anxiety Reduction Training Behavioral: Meditation and Anxiety Reduction Training	N/A

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

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are randomly assigned to one of three treatment arms: Anxiety Reduction Training (A.R.T.), ART with Kundalini Yoga, ART with MeditationParticipants 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)

Primary Purpose:

Treatment

Official Title:

Meditation and Yoga for Heightened Anxiety Related to COVID-19

Actual Study Start Date :

May 25, 2020

Actual Primary Completion Date :

Apr 19, 2021

Anticipated Study Completion Date :

Jan 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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. .	Behavioral: Anxiety Reduction Training Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress.
Experimental: 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.	Behavioral: Anxiety Reduction Training Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress. Behavioral: Kundalini Yoga and Anxiety Reduction Training 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.
Experimental: ART and Meditation This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing.	Behavioral: Anxiety Reduction Training Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress. Behavioral: Meditation and Anxiety Reduction Training Daily practice of meditation (muscle relaxation, breathing, and meditation) guided by on-line video instruction, as well as the biweekly anxiety reduction psychoeducation.

Arm

Intervention/Treatment

Active Comparator: 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. .

Behavioral: Anxiety Reduction Training

Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress.

Experimental: 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.

Behavioral: Anxiety Reduction Training

Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress.

Behavioral: Kundalini Yoga and Anxiety Reduction Training

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.

Experimental: ART and Meditation

This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing.

Behavioral: Anxiety Reduction Training

Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress.

Behavioral: Meditation and Anxiety Reduction Training

Daily practice of meditation (muscle relaxation, breathing, and meditation) guided by on-line video instruction, as well as the biweekly anxiety reduction psychoeducation.

Outcome Measures

Primary Outcome Measures

GAD-7 [Up to 32 weeks]
Generalized Anxiety Disorder 7-item scale (range 0-21, higher is worse)
Whiteley 8 [Up to 32 weeks]
Health Anxiety 8-item scale (range 0-32, higher is worse)

Secondary Outcome Measures

PHQ-8 [Up to 32 weeks]
Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher is worse)
SS-8 [Up to 32 weeks]
Somatic Symptom Scale-8 an 8-item measure of symptom burden (range 0-32, higher is worse)
Applied Cognition 1.0 [Up to 32 weeks]
An 8-item self-report measure of cognitive function (range 8-40, higher is worse)
PROMIS-4 Sleep Disturbance [Up to 32 weeks]
A 4-item self-report assessment of sleep disturbance (range 4-20, higher is worse)
ERQ [Up to 32 weeks]
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. ..
Perceived Stress Scale [Up to 32 weeks]
A 10-item scale assessing the perception of events in one's life as stressful (0-40, higher represents higher perception of stress)
Brief Hypervigilance Scale [Up to 32 weeks]
A 5-item scale assessing hypervigilance (0-20, higher represents greater hypervigilance)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProofPilot (Virtual Study: https://proofpilot.com/covid-anxiety/)	New York	New York	United States	10003
2	Columbia University Department of Psychiatry	New York	New York	United States	10032

Sponsors and Collaborators

Research Foundation for Mental Hygiene, Inc.

Investigators

Principal Investigator: Brian A Fallon, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Brian A Fallon, Professor of Psychiatry, Research Foundation for Mental Hygiene, Inc.

ClinicalTrials.gov Identifier:

NCT04386291

Other Study ID Numbers:

7987

First Posted:

May 13, 2020

Last Update Posted:

Jun 1, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Jun 1, 2021