All Studies · Anxiety & Stress · Simon (2021)

Simon (2021)

High · RCT · Clinical-Grade RCT · n = 226
Quality Index (Adjusted QI) 1.000
0 Low < 0.56 Moderate 0.56–0.77 High ≥ 0.78 1
Study Details
ConditionGeneralized anxiety disorder
Clinical domainAnxiety & Stress
PopulationAdults with GAD
Sample sizen = 226
Country / SettingUSA - multi-site academic medical centers
Protocol clusterKY-GAD (Y-CBT)
Duration12 weeks, 2 hr/week + 20 min/day
Control typeActive Control
ComparatorCBT + Stress Education
Outcomes & Effect Sizes
Primary outcomeAnxiety (GAD)
Scales usedCGI-I; HAMA; QIDS-SR; DSM-5 diagnosis
Key resultKY 54% response; CBT 71% response; KY > stress education but non-inferior to CBT
Effect sized = 0.54 (primary endpoint); small-moderate effect; non-inferior to CBT
ES value0.54 (d)
Retention91% (204/226 completed)
SafetyNo serious adverse events; excellent safety profile
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Methodological Summary

Randomized; 3-arm; masked raters; large sample; JAMA publication

KY Protocol Components

KY-GAD Protocol: 12-week Yoga-enhanced Cognitive Behavioral Therapy for Generalized Anxiety Disorder. STRUCTURE: Weekly 2-hour group classes + daily 20-min home practice KEY COMPONENTS: • Sessions 1-3: Sitali Breath, Basic Spinal Energy Series, Segmented Breath for Anxiety • Sessions 4-7: Alternate Nostril Breathing, Calmness and Anti-anxiety Series, Tattva Balance Beyond Stress & Duality • Sessions 8-12: Pauri Kriya (Sa-Ta-Na-Ma with segmented breathing), Stress Set for Adrenals and Kidneys, Shabad Kriya (sleep meditation) • Psychoeducation: Home practice fundamentals (weeks 1-3), meditation-in-action/mindfulness (4-6), self-efficacy/regulation (7-8), yogic lifestyle/habit maintenance (9-12) PROTOCOL DEVELOPMENT: Dr. Shanti Shanti Kaur Khalsa, Guru Ram Das Center for Mind-Body Medicine STUDY-SPECIFIC: Main RCT (n=226); primary outcomes: GAD-7, anxiety symptoms; published JAMA Psychiatry; landmark trial establishing efficacy.

Quality Item Scores — 1 fail · 2 partial · 3 pass · ★ critical
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3
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JP1
3
Critical fails0
Raw QI1.000
SAF1
Adjusted QI1.000
Final ratingHigh