Table 3

Non-inferiority tests (intent to treat)

TimeΔCPT*ΔSKY*ΔCPT–ΔSKY†One-sided p value‡
NMean (SD)NMean (SD)Mean95% CI
PCL (primary outcome)
 EOT44−6.8 (11.4)41−5.6 (9.5)−1.2(−5.7 to 3.3)0.0001
 1 month44−6.8 (11.9)41−4.8 (10.5)−2.1(−6.9 to 2.8)0.0008
 1 year44−6.2 (10.7)41−4.4 (11.4)−1.8(−6.6 to 2.9)0.0006
BDI-II
 EOT44−3.6 (10.9)41−6.1 (6.8)2.5(−1.4 to 6.4)0.0033
 1 month44−2.8 (11.7)41−4.7 (8.7)2(−2.5 to 6.4)0.0144
 1 year44−4.5 (10.0)41−5.6 (9.6)1.2(−3.1 to 5.4)0.0267
PANAS—positive affect
 EOT440.3 (5.9)412.5 (5.8)−2.2(−4.7 to 0.3)<0.0001
 1 month44−1.3 (7.1)411.3 (8.6)−2.6(−6.0 to 0.8)0.0008
 1 year440.4 (7.0)41−0.1 (10.5)0.5(−3.4 to 4.4)0.1053
PANAS—negative affect
 EOT44−0.9 (8.8)41−3.2 (4.6)2.3(−0.7 to 5.3)0.0004
 1 month44−1.2 (8.4)41−2.9 (6.7)1.7(−1.6 to 4.9)0.0029
 1 year44−1.7 (8.0)41−1.8 (8.2)0.1(−3.4 to 3.6)0.0411
  • *Δ denotes EOT score minus baseline score.

  • †Positive values for the difference in PCL-C, BDI-II and PANAS-negative affect measures’ change scores indicate more improvement in the SKY group than in the CPT group. Conversely, positive values for the difference in PANAS-positive affect change scores would indicate more improvement in the CPT group than in the SKY group.

  • ‡Alpha for these one-sided tests was 0.025. The non-inferiority margins were ≤10 points for the PCL-C, ≥3 for the BDI-II and PANAS positive and negative affect.

  • BDI-II, Beck Depression Inventory-II; CPT, cognitive processing therapy; PANAS, Positive and Negative Affect Schedule; PCL, post-traumatic stress disorder checklist; SKY, Sudarshan Kriya Yoga.