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

Generalized Anxiety Clinical Trial

Official title:

Meditation and Yoga for Heightened Anxiety Related to COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04386291
• Other study ID #: 7987
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: May 2021
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: January 30, 2022
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety
• Health Anxiety

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Department of Psychiatry	New York	New York
United States	ProofPilot (Virtual Study: https://proofpilot.com/covid-anxiety/)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

Andersson E, Enander J, Andrén P, Hedman E, Ljótsson B, Hursti T, Bergström J, Kaldo V, Lindefors N, Andersson G, Rück 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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GAD-7	Generalized Anxiety Disorder 7-item scale (range 0-21, higher is worse)	Up to 32 weeks
Primary	Whiteley 8	Health Anxiety 8-item scale (range 0-32, higher is worse)	Up to 32 weeks
Secondary	PHQ-8	Patient Health Questionnaire 8 - an 8 item measure of depression (range 0-24, higher is worse)	Up to 32 weeks
Secondary	SS-8	Somatic Symptom Scale-8 an 8-item measure of symptom burden (range 0-32, higher is worse)	Up to 32 weeks
Secondary	Applied Cognition 1.0	An 8-item self-report measure of cognitive function (range 8-40, higher is worse)	Up to 32 weeks
Secondary	PROMIS-4 Sleep Disturbance	A 4-item self-report assessment of sleep disturbance (range 4-20, higher is worse)	Up to 32 weeks
Secondary	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. ..	Up to 32 weeks
Secondary	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)	Up to 32 weeks
Secondary	Brief Hypervigilance Scale	A 5-item scale assessing hypervigilance (0-20, higher represents greater hypervigilance)	Up to 32 weeks