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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. . |
|
| 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. |
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| ART and Meditation | Experimental | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PHQ-8 | 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. | 8 weeks |
| SS-8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian A Fallon, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProofPilot (Virtual Study: https://proofpilot.com/covid-anxiety/) | New York | New York | 10003 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16262547 | Background | 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. | |
| 20876468 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. . 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2023 |
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Participants are randomly assigned to one of three treatment arms: Anxiety Reduction Training (A.R.T.), ART with Kundalini Yoga, ART with Meditation
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| 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. |
|
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.
| 8 weeks |
| Applied Cognition 1.0 | 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. | 8 weeks |
| PROMIS-4 Sleep Disturbance | 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. | 8 weeks |
| ERQ | 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. | 8 weeks |
| Perceived Stress Scale | 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. | 8 weeks |
| Brief Hypervigilance Scale | 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. | 8 weeks |
| Columbia University Department of Psychiatry |
| New York |
| New York |
| 10032 |
| United States |
| 24804619 | 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. |
| 31780963 | 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. |
| 29331704 | 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. |
| 32140427 | 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. |
| 22348650 | 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. |
| 27111302 | 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. |
| FG001 | 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. 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. |
| FG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. . 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. |
| BG001 | 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. 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. |
| BG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis of a change score between baseline and week 8 for those who those who were randomized into one of the study arms and completed active treatment phase. A larger positive change score indicates a greater improvement on a scale. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Primary | 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. | Analysis of a change score between baseline and week 8 for those who those who were randomized into one of the study arms and completed active treatment phase. A larger positive change score indicates a greater improvement on a scale. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PHQ-8 | 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. | Analysis of a change score between baseline and week 8 for those who those who were randomized into one of the study arms and completed active treatment phase. A larger positive change score indicates a greater improvement on a scale. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | SS-8 | 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. | Analysis of a change score between baseline and week 8 for those who those who were randomized into one of the study arms and completed active treatment phase. A larger positive change score indicates a greater improvement on a scale. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Applied Cognition 1.0 | 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. | Analysis of a change score between baseline and week 8 for those who those who were randomized into one of the study arms and completed active treatment phase. A larger negative change score indicates a greater improvement on a scale. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | PROMIS-4 Sleep Disturbance | 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. | Analysis of a change score between baseline and week 8 for those who those who were randomized into one of the study arms and completed active treatment phase. A larger positive change score indicates a greater improvement on a scale. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | ERQ | 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. | Analysis of a change score between baseline and week 8 for those who those who were randomized into one of the study arms and completed active treatment phase. A larger negative change score on the reappraisal subscale indicates a greater improvement on a scale. A larger positive change score on the suppression subscale indicates a greater improvement on a scale. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Perceived Stress Scale | 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. | Analysis of a change score between baseline and week 8 for those who those who were randomized into one of the study arms and completed active treatment phase. A larger positive change score indicates a greater improvement on a scale. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Brief Hypervigilance Scale | 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. | Analysis of a change score between baseline and week 8 for those who those who were randomized into one of the study arms and completed active treatment phase. A larger positive change score indicates a greater improvement on a scale. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
8 weeks of acute treatment phase
Adverse events information was collected via online platform at baseline and 8 weeks with a Healthcare Utilization questionnaire. Questions addressed adverse experiences and overnight hospitalizations. In addition, participants could reach out to research team if they experienced any distress with their program of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. . 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. | 0 | 83 | 0 | 83 | 0 | 83 |
| EG001 | 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. 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. | 0 | 88 | 0 | 88 | 0 | 88 |
| EG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. | 0 | 85 | 0 | 85 | 0 | 85 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian A Fallon | NYS Psychiatric Institute | 646-774-8052 | baf1@cumc.columbia.edu |
| Dec 21, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Male |
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| Transgender |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Mean Difference (Final Values) |
| -0.09 |
| 2-Sided |
| Superiority |
| OG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. |
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| OG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. |
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| OG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. |
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| OG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. |
|
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| OG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. |
|
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| OG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. |
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| OG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. |
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| OG002 | ART and Meditation | This combines ART with a daily 15 minute meditation with stress reduction techniques and guided breathing. 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. 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. |
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