Table 2. Changes in outcomes from baseline to 1, 3, and 6-month follow-up post-intervention among study completers (PP-analysis, N=88) and ITT-analysis for the primary outcome PSQ_total considering all randomized persons (participants N=90 and non-participants N=19) with missing value imputation using the “Last Observation Carried Forward” method.
Intervention Group | Waiting Control Group | |||||||||
Change from baseline | Change from baseline | Change from baseline – Difference between groups | Effect size | Between-group ANCOVA*1 | ||||||
N | Mean | SD | N | Mean | SD | Mean [95%CI] | Pooled SD | Cohen’s d | Parameter estimate for group [95%CI] | |
PSQ_total (PP) | ||||||||||
at 1 month | 43 | –33.45 | 14.21 | 45 | –1.85 | 9.46 | –31.60 [–37.07; –24.61]*2 | 12.02 | –2.63 | –31.37 [–36.20; –26.54]*4 |
at 3 months | 43 | –27.13 | 15.70 | 44 | –5.64 | 15.49 | –21.49 [–28.25; –13.50]*2 | 15.59 | –1.38 | –21.27 [–27.65; –14.89]*4 |
at 6 months | 43 | –28.33 | 16.50 | 44 | –2.84 | 10.77 | –25.49 [–32.13; –18.46]*2 | 13.90 | –1.83 | –25.43 [–31.09; –19.77]*4 |
PSQ_total (ITT) | ||||||||||
at 1 month | 54 | –26.64 | 18.57 | 55 | –1.73 | 8.67 | –24.91 [–31.42; –18.45]*2 | 14.45 | –1.72 | –24.92 [–30.27; –19.56]*4 |
at 3 months | 54 | –21.60 | 17.81 | 55 | –3.94 | 14.51 | –17.66 [–24.60; –10.78]*2 | 16.23 | –1.09 | –17.67 [–23.67; –11.68]*4 |
at 6 months | 54 | –22.56 | 18.67 | 55 | –2.00 | 10.00 | –20.56 [–27.20; –13.97]*2 | 14.94 | –1.38 | –20.57 [–26.09; –15.04]*4 |
WHO-5 (PP) | ||||||||||
at 1 month | 43 | 32.65 | 16.28 | 45 | 3.47 | 15.27 | 29.18 [22.76; 38.04]*2 | 15.77 | 1.85 | 29.60 [23.23; 35.96]*4 |
at 3 months | 43 | 24.09 | 18.75 | 44 | 5.18 | 14.78 | 18.91 [11.29; 28.51]*2 | 16.86 | 1.12 | 19.15 [12.09; 26.21]*4 |
at 6 months | 43 | 23.44 | 20.80 | 44 | 2.18 | 15.42 | 21.26 [14.95; 31.54]*2 | 18.28 | 1.16 | 22.07 [14.67; 29.48]*4 |
MBI_EE (PP) | ||||||||||
at 1 month | 42 | –1.08 | 0.79 | 45 | 0 | 0.55 | –1.08 [–1.30; –0.71]*2 | 0.68 | –1.59 | –1.05 [–1.31; –0.79]*4 |
at 3 months | 42 | –1.06 | 0.72 | 44 | 0.07 | 0.56 | –1.13 [–1.38; –0.70]*2 | 0.64 | –1.77 | –1.11 [–1.38; –0.84]*4 |
at 6 months | 41 | –1.03 | 0.95 | 45 | 0.08 | 0.54 | –1.11 [–1.44; –0.68]*2 | 0.76 | –1.46 | –1.10 [–1.42; –0.78]*4 |
EQ5D_Health state (PP) | ||||||||||
at 1 month | 42 | 21.12 | 15.86 | 45 | 2.18 | 17.35 | 18.94 [9.39; 21.27]*2 | 16.65 | 1.14 | 16.55 [10.95; 22.15]*4 |
at 3 months | 42 | 17.07 | 19.31 | 45 | 1.64 | 17.35 | 15.43 [4.90; 17.85]*3 | 18.32 | 0.84 | 12.85 [6.60; 19.09]*5 |
at 6 months | 42 | 19.71 | 16.93 | 43 | 3.67 | 16.97 | 16.04 [5.29; 18.43]*3 | 16.95 | 0.95 | 13.74 [7.69; 19.79]*4 |
*1 Between-group ANCOVA adjusted for baseline values (in the case of non-participants values from eligibility testing were used)
*2 p-value for t-test comparison of means between groups <0.0001;
*3 p-value for t-test comparison of means between groups <0.001
*4 p-value for between-group ANCOVA <0.0001;
*5 p-value for between-group ANCOVA <0.001