Meditation and Kundalini Yoga for Heightened Anxiety Related to COVID-19
Primary Purpose
Generalized Anxiety, Health Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anxiety Reduction Training
Kundalini Yoga and Anxiety Reduction Training
Meditation and Anxiety Reduction Training
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety
Eligibility Criteria
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
Sites / Locations
- ProofPilot (Virtual Study: https://proofpilot.com/covid-anxiety/)
- Columbia University Department of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Anxiety Reduction Training (A.R.T.)
ART and Kundalini Yoga
ART and Meditation
Arm Description
Participants will received biweekly on-line lessons that provide education and strategies to reduce stress and disturbing thoughts and improve healthy coping and sleep. .
This combines ART with a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer.
This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing.
Outcomes
Primary Outcome Measures
GAD-7
Generalized Anxiety Disorder 7-item scale (range 0-21, higher is worse)
Whiteley 8
Health Anxiety 8-item scale (range 0-32, higher is worse)
Secondary Outcome Measures
PHQ-8
Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher is worse)
SS-8
Somatic Symptom Scale-8 an 8-item measure of symptom burden (range 0-32, higher is worse)
Applied Cognition 1.0
An 8-item self-report measure of cognitive function (range 8-40, higher is worse)
PROMIS-4 Sleep Disturbance
A 4-item self-report assessment of sleep disturbance (range 4-20, higher is worse)
ERQ
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
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
A 5-item scale assessing hypervigilance (0-20, higher represents greater hypervigilance)
Full Information
NCT ID
NCT04386291
First Posted
May 11, 2020
Last Updated
May 27, 2021
Sponsor
Research Foundation for Mental Hygiene, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04386291
Brief Title
Meditation and Kundalini Yoga for Heightened Anxiety Related to COVID-19
Official Title
Meditation and Yoga for Heightened Anxiety Related to COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
January 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Foundation for Mental Hygiene, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety, Health Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anxiety Reduction Training (A.R.T.)
Arm Type
Active Comparator
Arm Description
Participants will received biweekly on-line lessons that provide education and strategies to reduce stress and disturbing thoughts and improve healthy coping and sleep. .
Arm Title
ART and Kundalini Yoga
Arm Type
Experimental
Arm Description
This combines ART with a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer.
Arm Title
ART and Meditation
Arm Type
Experimental
Arm Description
This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing.
Intervention Type
Behavioral
Intervention Name(s)
Anxiety Reduction Training
Intervention Description
Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress.
Intervention Type
Behavioral
Intervention Name(s)
Kundalini Yoga and Anxiety Reduction Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Meditation and Anxiety Reduction Training
Intervention Description
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 Measure Information:
Title
GAD-7
Description
Generalized Anxiety Disorder 7-item scale (range 0-21, higher is worse)
Time Frame
Up to 32 weeks
Title
Whiteley 8
Description
Health Anxiety 8-item scale (range 0-32, higher is worse)
Time Frame
Up to 32 weeks
Secondary Outcome Measure Information:
Title
PHQ-8
Description
Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher is worse)
Time Frame
Up to 32 weeks
Title
SS-8
Description
Somatic Symptom Scale-8 an 8-item measure of symptom burden (range 0-32, higher is worse)
Time Frame
Up to 32 weeks
Title
Applied Cognition 1.0
Description
An 8-item self-report measure of cognitive function (range 8-40, higher is worse)
Time Frame
Up to 32 weeks
Title
PROMIS-4 Sleep Disturbance
Description
A 4-item self-report assessment of sleep disturbance (range 4-20, higher is worse)
Time Frame
Up to 32 weeks
Title
ERQ
Description
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. ..
Time Frame
Up to 32 weeks
Title
Perceived Stress Scale
Description
A 10-item scale assessing the perception of events in one's life as stressful (0-40, higher represents higher perception of stress)
Time Frame
Up to 32 weeks
Title
Brief Hypervigilance Scale
Description
A 5-item scale assessing hypervigilance (0-20, higher represents greater hypervigilance)
Time Frame
Up to 32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian A Fallon, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProofPilot (Virtual Study: https://proofpilot.com/covid-anxiety/)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia University Department of Psychiatry
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16262547
Citation
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Results Reference
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20876468
Citation
Grossman P, Kappos L, Gensicke H, D'Souza M, Mohr DC, Penner IK, Steiner C. MS quality of life, depression, and fatigue improve after mindfulness training: a randomized trial. Neurology. 2010 Sep 28;75(13):1141-9. doi: 10.1212/WNL.0b013e3181f4d80d.
Results Reference
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PubMed Identifier
24804619
Citation
Khalsa MK, Greiner-Ferris JM, Hofmann SG, Khalsa SB. Yoga-enhanced cognitive behavioural therapy (Y-CBT) for anxiety management: a pilot study. Clin Psychol Psychother. 2015 Jul-Aug;22(4):364-71. doi: 10.1002/cpp.1902. Epub 2014 May 7.
Results Reference
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PubMed Identifier
31780963
Citation
Shannahoff-Khalsa D, Fernandes RY, Pereira CAB, March JS, Leckman JF, Golshan S, Vieira MSR, Polanczyk GV, Miguel EC, Shavitt RG. Kundalini Yoga Meditation Versus the Relaxation Response Meditation for Treating Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial. Front Psychiatry. 2019 Nov 11;10:793. doi: 10.3389/fpsyt.2019.00793. eCollection 2019.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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Andersson E, Enander J, Andren P, Hedman E, Ljotsson B, Hursti T, Bergstrom J, Kaldo V, Lindefors N, Andersson G, Ruck C. Internet-based cognitive behaviour therapy for obsessive-compulsive disorder: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2193-203. doi: 10.1017/S0033291712000244. Epub 2012 Feb 21.
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Meditation and Kundalini Yoga for Heightened Anxiety Related to COVID-19
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