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

NCT04386291 | Completed Results

• 1 other identifier: 7987
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 2

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.

Conditions

Generalized Anxiety; Health Anxiety

Outcome Measures

Primary Outcomes (2)

• GAD-7

  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.

  8 weeks

• Whiteley 8

  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.

  8 weeks

Secondary Outcomes (7)

• PHQ-8

  8 weeks

• SS-8

  8 weeks

• Applied Cognition 1.0

  8 weeks

• PROMIS-4 Sleep Disturbance

  8 weeks

• ERQ

  8 weeks

Study Arms (3)

Anxiety Reduction Training (A.R.T.)

ACTIVE COMPARATOR

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

ART and Kundalini Yoga

EXPERIMENTAL

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; Behavioral: Kundalini Yoga and Anxiety Reduction Training

ART and Meditation

EXPERIMENTAL

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

Behavioral: Anxiety Reduction Training; Behavioral: Meditation and Anxiety Reduction Training

Interventions

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.

ART and Kundalini Yoga; ART and Meditation; Anxiety Reduction Training (A.R.T.)

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.

ART and Kundalini Yoga

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.

ART and Meditation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead

Study Sites (2)

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

New York, New York, 10003, United States

Location

Columbia University Department of Psychiatry

New York, New York, 10032, United States

Location

Related Publications (8)

• 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.

  PMID: 16262547 BACKGROUND

• 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.

  PMID: 20876468 BACKGROUND

• 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.

  PMID: 24804619 BACKGROUND

• 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.

  PMID: 31780963 BACKGROUND

• 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.

  PMID: 29331704 BACKGROUND

• 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.

  PMID: 32140427 BACKGROUND

• 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.

  PMID: 22348650 BACKGROUND

• 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.

  PMID: 27111302 BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Meditation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Brian A Fallon
• Organization: NYS Psychiatric Institute

baf1@cumc.columbia.edu

646-774-8052

Study Officials

• Brian A Fallon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

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

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 13, 2020
• Study Start: May 25, 2020
• Primary Completion: April 19, 2021
• Study Completion: January 30, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)