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Completed

NCT Number: NCT04386291

Meditation and Kundalini 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.

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Key information

Conditions

Generalized Anxiety Anxiety Disorders Generalized Anxiety Disorder Health Anxiety Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Department of Psychiatry, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anxiety Reduction Training

Behavioral

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

Kundalini Yoga and Anxiety Reduction Training

Behavioral

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.

Meditation and Anxiety Reduction Training

Behavioral

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

Primary outcomes

  1. GAD-7

    Time frame: 8 weeks

    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.

  2. Whiteley 8

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. PHQ-8

    Time frame: 8 weeks

    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.

  2. SS-8

    Time frame: 8 weeks

    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.

  3. Applied Cognition 1.0

    Time frame: 8 weeks

    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.

  4. PROMIS-4 Sleep Disturbance

    Time frame: 8 weeks

    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.

  5. ERQ

    Time frame: 8 weeks

    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.

  6. Perceived Stress Scale

    Time frame: 8 weeks

    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.

  7. Brief Hypervigilance Scale

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Research Foundation for Mental Hygiene, Inc.

Other

Registry information

Official study title

Meditation and Yoga for Heightened Anxiety Related to COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 13, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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