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

May 27, 2021 updated by: Brian A Fallon, Research Foundation for Mental Hygiene, Inc.

Meditation and Yoga for Heightened Anxiety Related to COVID-19

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • ProofPilot (Virtual Study: https://proofpilot.com/covid-anxiety/)
      • New York, New York, United States, 10032
        • Columbia University Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GAD-7
Time Frame: Up to 32 weeks
Generalized Anxiety Disorder 7-item scale (range 0-21, higher is worse)
Up to 32 weeks
Whiteley 8
Time Frame: Up to 32 weeks
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
Time Frame: Up to 32 weeks
Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher is worse)
Up to 32 weeks
SS-8
Time Frame: Up to 32 weeks
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
Time Frame: Up to 32 weeks
An 8-item self-report measure of cognitive function (range 8-40, higher is worse)
Up to 32 weeks
PROMIS-4 Sleep Disturbance
Time Frame: Up to 32 weeks
A 4-item self-report assessment of sleep disturbance (range 4-20, higher is worse)
Up to 32 weeks
ERQ
Time Frame: 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. ..
Up to 32 weeks
Perceived Stress Scale
Time Frame: 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)
Up to 32 weeks
Brief Hypervigilance Scale
Time Frame: Up to 32 weeks
A 5-item scale assessing hypervigilance (0-20, higher represents greater hypervigilance)
Up to 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Foundation for Mental Hygiene, Inc.

Investigators

  • Principal Investigator: Brian A Fallon, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2020

Primary Completion (Actual)

April 19, 2021

Study Completion (Anticipated)

January 30, 2022

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7987

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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