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

NCT ID: NCT04386291

Last Updated: 2024-09-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2022-01-30

Brief Summary

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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

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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.

Conditions

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Generalized Anxiety Health Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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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. .

Group Type ACTIVE_COMPARATOR

Anxiety Reduction Training

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Anxiety Reduction Training

Intervention Type 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

Intervention Type 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.

ART and Meditation

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

Group Type EXPERIMENTAL

Anxiety Reduction Training

Intervention Type BEHAVIORAL

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

Meditation and Anxiety Reduction Training

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Brian A Fallon

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian A Fallon, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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ProofPilot (Virtual Study: https://proofpilot.com/covid-anxiety/)

New York, New York, United States

Site Status

Columbia University Department of Psychiatry

New York, New York, United States

Site Status

Countries

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United States

References

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Carlson LE, Garland SN. Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Int J Behav Med. 2005;12(4):278-85. doi: 10.1207/s15327558ijbm1204_9.

Reference Type BACKGROUND
PMID: 16262547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20876468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24804619 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31780963 (View on PubMed)

Wang YY, Li XH, Zheng W, Xu ZY, Ng CH, Ungvari GS, Yuan Z, Xiang YT. Mindfulness-based interventions for major depressive disorder: A comprehensive meta-analysis of randomized controlled trials. J Affect Disord. 2018 Mar 15;229:429-436. doi: 10.1016/j.jad.2017.12.093. Epub 2018 Jan 3.

Reference Type BACKGROUND
PMID: 29331704 (View on PubMed)

Kladnitski N, Smith J, Uppal S, James MA, Allen AR, Andrews G, Newby JM. Transdiagnostic internet-delivered CBT and mindfulness-based treatment for depression and anxiety: A randomised controlled trial. Internet Interv. 2020 Feb 13;20:100310. doi: 10.1016/j.invent.2020.100310. eCollection 2020 Apr.

Reference Type BACKGROUND
PMID: 32140427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22348650 (View on PubMed)

Spijkerman MP, Pots WT, Bohlmeijer ET. Effectiveness of online mindfulness-based interventions in improving mental health: A review and meta-analysis of randomised controlled trials. Clin Psychol Rev. 2016 Apr;45:102-14. doi: 10.1016/j.cpr.2016.03.009. Epub 2016 Apr 1.

Reference Type BACKGROUND
PMID: 27111302 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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7987

Identifier Type: -

Identifier Source: org_study_id

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