Generalized Anxiety, Health Anxiety
Conditions
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.
Detailed 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.
Interventions
BEHAVIORALAnxiety 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.
BEHAVIORALKundalini 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.
BEHAVIORALMeditation 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.
Sponsors
Research Foundation for Mental Hygiene, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned to one of three treatment arms: Anxiety Reduction Training (A.R.T.), ART with Kundalini Yoga, ART with Meditation
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GAD-7 | 8 weeks | 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. |
| Whiteley 8 | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Applied Cognition 1.0 | 8 weeks | 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. |
| PROMIS-4 Sleep Disturbance | 8 weeks | 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. |
| PHQ-8 | 8 weeks | 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. |
| Perceived Stress Scale | 8 weeks | 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. |
| Brief Hypervigilance Scale | 8 weeks | 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. |
| ERQ | 8 weeks | 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. |
| SS-8 | 8 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 83 |
| 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. | 88 |
| 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. | 85 |
| Total | 256 |
Baseline characteristics
| Characteristic | ART and Kundalini Yoga | Anxiety Reduction Training (A.R.T.) | ART and Meditation | Total |
|---|---|---|---|---|
| Age, Continuous | 45.6 years STANDARD_DEVIATION 12.7 | 47.2 years STANDARD_DEVIATION 13.4 | 49.6 years STANDARD_DEVIATION 13.3 | 47.4 years STANDARD_DEVIATION 13.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 4 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 74 Participants | 77 Participants | 74 Participants | 225 Participants |
| Region of Enrollment United States | 88 participants | 83 participants | 85 participants | 256 participants |
| Sex/Gender, Customized Female | 81 Participants | 72 Participants | 75 Participants | 228 Participants |
| Sex/Gender, Customized Male | 6 Participants | 11 Participants | 10 Participants | 27 Participants |
| Sex/Gender, Customized Transgender | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 88 | 0 / 85 |
| other Total, other adverse events | 0 / 83 | 0 / 88 | 0 / 85 |
| serious Total, serious adverse events | 0 / 83 | 0 / 88 | 0 / 85 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anxiety Reduction Training (A.R.T.) | GAD-7 | 4.7 score on a scale | Standard Deviation 4.4 |
| ART and Kundalini Yoga | GAD-7 | 7.8 score on a scale | Standard Deviation 2.9 |
| ART and Meditation | GAD-7 | 4.9 score on a scale | Standard Deviation 4.6 |
p-value: 0.071t-test, 1 sided
p-value: 0.46t-test, 1 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anxiety Reduction Training (A.R.T.) | Whiteley 8 | 0.05 score on a scale | Standard Deviation 4.9 |
| ART and Kundalini Yoga | Whiteley 8 | 3.9 score on a scale | Standard Deviation 3.4 |
| ART and Meditation | Whiteley 8 | 2.5 score on a scale | Standard Deviation 4.5 |
p-value: 0.01t-test, 1 sided
p-value: 0.04t-test, 1 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anxiety Reduction Training (A.R.T.) | Applied Cognition 1.0 | -4.1 score on a scale | Standard Deviation 5.5 |
| ART and Kundalini Yoga | Applied Cognition 1.0 | -6.6 score on a scale | Standard Deviation 5.5 |
| ART and Meditation | Applied Cognition 1.0 | -5.1 score on a scale | Standard Deviation 6.5 |
p-value: 0.88t-test, 1 sided
p-value: 0.7t-test, 1 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anxiety Reduction Training (A.R.T.) | Brief Hypervigilance Scale | 1.2 score on a scale | Standard Deviation 2.4 |
| ART and Kundalini Yoga | Brief Hypervigilance Scale | 3.5 score on a scale | Standard Deviation 4.1 |
| ART and Meditation | Brief Hypervigilance Scale | 0.4 score on a scale | Standard Deviation 3.2 |
p-value: 0.076Wilcoxon (Mann-Whitney)
p-value: 0.8t-test, 1 sided
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anxiety Reduction Training (A.R.T.) | ERQ | Reappraisal Subscale | -1.9 score on a scale | Standard Deviation 4.7 |
| Anxiety Reduction Training (A.R.T.) | ERQ | Suppression Subscale | -16.2 score on a scale | Standard Deviation 8.1 |
| ART and Kundalini Yoga | ERQ | Reappraisal Subscale | -5.5 score on a scale | Standard Deviation 7.8 |
| ART and Kundalini Yoga | ERQ | Suppression Subscale | -13.9 score on a scale | Standard Deviation 9.1 |
| ART and Meditation | ERQ | Reappraisal Subscale | -2.9 score on a scale | Standard Deviation 6.3 |
| ART and Meditation | ERQ | Suppression Subscale | -16.5 score on a scale | Standard Deviation 8.9 |
Comparison: Reappraisal subscale analysisp-value: 0.9t-test, 1 sided
Comparison: Subpression subscale analysisp-value: 0.23t-test, 1 sided
Comparison: Reappraisal subscale analysisp-value: 0.7t-test, 1 sided
Comparison: Suppression subscale analysisp-value: 0.5t-test, 1 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anxiety Reduction Training (A.R.T.) | Perceived Stress Scale | 4.1 score on a scale | Standard Deviation 6.5 |
| ART and Kundalini Yoga | Perceived Stress Scale | 6.0 score on a scale | Standard Deviation 5.9 |
| ART and Meditation | Perceived Stress Scale | 6.5 score on a scale | Standard Deviation 8.1 |
p-value: 0.5ANOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anxiety Reduction Training (A.R.T.) | PHQ-8 | 4.8 score on a scale | Standard Deviation 3.7 |
| ART and Kundalini Yoga | PHQ-8 | 7.8 score on a scale | Standard Deviation 5.3 |
| ART and Meditation | PHQ-8 | 4.5 score on a scale | Standard Deviation 6.1 |
p-value: 0.08t-test, 1 sided
p-value: 0.5t-test, 1 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anxiety Reduction Training (A.R.T.) | PROMIS-4 Sleep Disturbance | 1.5 score on a scale | Standard Deviation 3 |
| ART and Kundalini Yoga | PROMIS-4 Sleep Disturbance | 3.7 score on a scale | Standard Deviation 3.8 |
| ART and Meditation | PROMIS-4 Sleep Disturbance | 3.3 score on a scale | Standard Deviation 4.3 |
p-value: 0.038t-test, 1 sided
p-value: 0.059t-test, 1 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anxiety Reduction Training (A.R.T.) | SS-8 | -3.8 score on a scale | Standard Deviation 4.4 |
| ART and Kundalini Yoga | SS-8 | -2.8 score on a scale | Standard Deviation 4.1 |
| ART and Meditation | SS-8 | -1.7 score on a scale | Standard Deviation 4.5 |
p-value: 0.25t-test, 1 sided
p-value: 0.065t-test, 1 sided