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

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ClinicalTrials.gov Identifier: NCT04386291
Recruitment Status : Active, not recruiting
First Posted : May 13, 2020
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Brian A Fallon, Research Foundation for Mental Hygiene, Inc.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : April 19, 2021
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. GAD-7 [ Time Frame: Up to 32 weeks ]
    Generalized Anxiety Disorder 7-item scale (range 0-21, higher is worse)

  2. Whiteley 8 [ Time Frame: Up to 32 weeks ]
    Health Anxiety 8-item scale (range 0-32, higher is worse)


Secondary Outcome Measures :
  1. PHQ-8 [ Time Frame: Up to 32 weeks ]
    Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher is worse)

  2. 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)

  3. 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)

  4. 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)

  5. 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. ..

  6. 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)

  7. Brief Hypervigilance Scale [ Time Frame: Up to 32 weeks ]
    A 5-item scale assessing hypervigilance (0-20, higher represents greater hypervigilance)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386291


Locations
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United States, New York
ProofPilot (Virtual Study: https://proofpilot.com/covid-anxiety/)
New York, New York, United States, 10003
Columbia University Department of Psychiatry
New York, New York, United States, 10032
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Investigators
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Principal Investigator: Brian A Fallon, MD Columbia University
Publications:

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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    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders