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Meditation and Kundalini Yoga for Heightened Anxiety Related to COVID-19
NA trial testing Anxiety Reduction Training in Generalized Anxiety in 256 participants. Completed in 30 January 2022.
| Lead sponsor | Research Foundation for Mental Hygiene, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 256 |
| Start date | 25 May 2020 |
| Primary completion | 19 April 2021 |
| Estimated completion | 30 January 2022 |
| Sites | 2 locations across United States |
Research Foundation for Mental Hygiene, Inc.
Adults 18 to 70, any sex, with Generalized Anxiety or Health Anxiety. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Anxiety Reduction Training (A.R.T.) | 4.7 | ± 4.4 |
| ART and Kundalini Yoga | 7.8 | ± 2.9 |
| ART and Meditation | 4.9 | ± 4.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Anxiety Reduction Training (A.R.T.) | 0.05 | ± 4.9 |
| ART and Kundalini Yoga | 3.9 | ± 3.4 |
| ART and Meditation | 2.5 | ± 4.5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Anxiety Reduction Training (A.R.T.) | 4.8 | ± 3.7 |
| ART and Kundalini Yoga | 7.8 | ± 5.3 |
| ART and Meditation | 4.5 | ± 6.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Anxiety Reduction Training (A.R.T.) | -3.8 | ± 4.4 |
| ART and Kundalini Yoga | -2.8 | ± 4.1 |
| ART and Meditation | -1.7 | ± 4.5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Anxiety Reduction Training (A.R.T.) | -4.1 | ± 5.5 |
| ART and Kundalini Yoga | -6.6 | ± 5.5 |
| ART and Meditation | -5.1 | ± 6.5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Anxiety Reduction Training (A.R.T.) | 1.5 | ± 3.0 |
| ART and Kundalini Yoga | 3.7 | ± 3.8 |
| ART and Meditation | 3.3 | ± 4.3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Anxiety Reduction Training (A.R.T.) | -1.9 | ± 4.7 |
| ART and Kundalini Yoga | -5.5 | ± 7.8 |
| ART and Meditation | -2.9 | ± 6.3 |
| Group | Value | 95% CI |
|---|---|---|
| Anxiety Reduction Training (A.R.T.) | -16.2 | ± 8.1 |
| ART and Kundalini Yoga | -13.9 | ± 9.1 |
| ART and Meditation | -16.5 | ± 8.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Anxiety Reduction Training (A.R.T.) | 4.1 | ± 6.5 |
| ART and Kundalini Yoga | 6.0 | ± 5.9 |
| ART and Meditation | 6.5 | ± 8.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Anxiety Reduction Training (A.R.T.) | 1.2 | ± 2.4 |
| ART and Kundalini Yoga | 3.5 | ± 4.1 |
| ART and Meditation | 0.4 | ± 3.2 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04386291.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing