Trial Outcomes & Findings for Meditation and Kundalini Yoga for Heightened Anxiety Related to COVID-19 (NCT NCT04386291)

NCT ID: NCT04386291

Last Updated: 2024-09-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

256 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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.
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.
Overall Study
STARTED
83
88
85
Overall Study
COMPLETED
21
12
23
Overall Study
NOT COMPLETED
62
76
62

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Anxiety Reduction Training (A.R.T.)
n=83 Participants
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.
ART and Kundalini Yoga
n=88 Participants
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.
ART and Meditation
n=85 Participants
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.
Total
n=256 Participants
Total of all reporting groups
Age, Continuous
47.2 years
STANDARD_DEVIATION 13.4 • n=5 Participants
45.6 years
STANDARD_DEVIATION 12.7 • n=7 Participants
49.6 years
STANDARD_DEVIATION 13.3 • n=5 Participants
47.4 years
STANDARD_DEVIATION 13.2 • n=4 Participants
Sex/Gender, Customized
Female
72 Participants
n=5 Participants
81 Participants
n=7 Participants
75 Participants
n=5 Participants
228 Participants
n=4 Participants
Sex/Gender, Customized
Male
11 Participants
n=5 Participants
6 Participants
n=7 Participants
10 Participants
n=5 Participants
27 Participants
n=4 Participants
Sex/Gender, Customized
Transgender
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
5 Participants
n=7 Participants
3 Participants
n=5 Participants
12 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
7 Participants
n=4 Participants
Race (NIH/OMB)
White
77 Participants
n=5 Participants
74 Participants
n=7 Participants
74 Participants
n=5 Participants
225 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
5 Participants
n=7 Participants
4 Participants
n=5 Participants
10 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
Region of Enrollment
United States
83 participants
n=5 Participants
88 participants
n=7 Participants
85 participants
n=5 Participants
256 participants
n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Anxiety Reduction Training (A.R.T.)
n=14 Participants
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.
ART and Kundalini Yoga
n=6 Participants
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.
ART and Meditation
n=16 Participants
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.
GAD-7
4.7 score on a scale
Standard Deviation 4.4
7.8 score on a scale
Standard Deviation 2.9
4.9 score on a scale
Standard Deviation 4.6

PRIMARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Anxiety Reduction Training (A.R.T.)
n=21 Participants
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.
ART and Kundalini Yoga
n=12 Participants
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.
ART and Meditation
n=23 Participants
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.
Whiteley 8
0.05 score on a scale
Standard Deviation 4.9
3.9 score on a scale
Standard Deviation 3.4
2.5 score on a scale
Standard Deviation 4.5

SECONDARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Anxiety Reduction Training (A.R.T.)
n=13 Participants
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.
ART and Kundalini Yoga
n=6 Participants
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.
ART and Meditation
n=15 Participants
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.
PHQ-8
4.8 score on a scale
Standard Deviation 3.7
7.8 score on a scale
Standard Deviation 5.3
4.5 score on a scale
Standard Deviation 6.1

SECONDARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Anxiety Reduction Training (A.R.T.)
n=21 Participants
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.
ART and Kundalini Yoga
n=12 Participants
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.
ART and Meditation
n=23 Participants
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.
SS-8
-3.8 score on a scale
Standard Deviation 4.4
-2.8 score on a scale
Standard Deviation 4.1
-1.7 score on a scale
Standard Deviation 4.5

SECONDARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Anxiety Reduction Training (A.R.T.)
n=21 Participants
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.
ART and Kundalini Yoga
n=11 Participants
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.
ART and Meditation
n=21 Participants
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.
Applied Cognition 1.0
-4.1 score on a scale
Standard Deviation 5.5
-6.6 score on a scale
Standard Deviation 5.5
-5.1 score on a scale
Standard Deviation 6.5

SECONDARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Anxiety Reduction Training (A.R.T.)
n=21 Participants
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.
ART and Kundalini Yoga
n=11 Participants
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.
ART and Meditation
n=23 Participants
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.
PROMIS-4 Sleep Disturbance
1.5 score on a scale
Standard Deviation 3.0
3.7 score on a scale
Standard Deviation 3.8
3.3 score on a scale
Standard Deviation 4.3

SECONDARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Anxiety Reduction Training (A.R.T.)
n=21 Participants
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.
ART and Kundalini Yoga
n=11 Participants
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.
ART and Meditation
n=23 Participants
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.
ERQ
Reappraisal Subscale
-1.9 score on a scale
Standard Deviation 4.7
-5.5 score on a scale
Standard Deviation 7.8
-2.9 score on a scale
Standard Deviation 6.3
ERQ
Suppression Subscale
-16.2 score on a scale
Standard Deviation 8.1
-13.9 score on a scale
Standard Deviation 9.1
-16.5 score on a scale
Standard Deviation 8.9

SECONDARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Anxiety Reduction Training (A.R.T.)
n=21 Participants
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.
ART and Kundalini Yoga
n=11 Participants
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.
ART and Meditation
n=22 Participants
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.
Perceived Stress Scale
4.1 score on a scale
Standard Deviation 6.5
6.0 score on a scale
Standard Deviation 5.9
6.5 score on a scale
Standard Deviation 8.1

SECONDARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Anxiety Reduction Training (A.R.T.)
n=21 Participants
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.
ART and Kundalini Yoga
n=11 Participants
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.
ART and Meditation
n=22 Participants
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.
Brief Hypervigilance Scale
1.2 score on a scale
Standard Deviation 2.4
3.5 score on a scale
Standard Deviation 4.1
0.4 score on a scale
Standard Deviation 3.2

Adverse Events

Anxiety Reduction Training (A.R.T.)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

ART and Kundalini Yoga

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

ART and Meditation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brian A Fallon

NYS Psychiatric Institute

Phone: 646-774-8052

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place