Outcomes: | Baseline | Week 6 | Week 12 (after treatment) | Week 24 | p-value between groups over time*** | p-value within groups over time | |
---|---|---|---|---|---|---|---|
Primary outcome: Median (IQR) | |||||||
% work-hours RTW (0–100)** | Intervention | 0.0 (1.25) | – | 22.5 (66.67) | 94.7 (80.63) | 0.92 | |
Placebo | 0.0 (24.31) | – | 14.3 (64.50) | 88.2 (58.54) | |||
Control | 0.0 (0.00) | – | 25.0 (52.50) | 62.5 (72.31) | |||
Total group | 0.0 (4.06) | 20.0 (60.56) | 87.5 (70.94) | 0.00 | |||
Secondary outcomes: | |||||||
Emotional exhaustion* | Intervention | 4.9 (1.28) | – | 3.2 (1.46) | 0.20 | ||
Placebo | 5.2 (1.26) | – | 2.6 (1.30) | ||||
Control | 5.3 (0.89) | – | 3.2 (1.63) | ||||
Total group | 5.1 (1.16) | 3.0 (1.47) | 0.00 | ||||
Work-related fatigue(0–100)*Median (IQR) | Intervention | 90.9 (27.27) | 72.7 (50.0) | 40.9 (59.09) | – | 0.70 | |
Placebo | 90.9 (15.91) | 72.7 (43.18) | 40.9 (52.27) | – | |||
Control | 90.9 (9.09) | 81.8 (50.0) | 50.0 (68.18) | – | |||
Total group | 90.9 (25.0) | 81.8 (43.18) | 45.5 (63.6) | 0.00 | |||
Vitality (QoL) (0–100)** | Intervention | 31.7 (18.82) | 44.3(18.60) | 52.7 (21.32) | – | 0.20 | |
Placebo | 29.2 (17.80) | 46.6(17.95) | 63.2 (16.40) | – | |||
Control | 27.8 (13.50) | 40.5(16.26) | 52.1(18.88) | – | |||
Total group | 29.6 (16.76) | 43.7 (17.59) | 53.0 (19.43) | 0.00 | |||
Stress (0–64)* | Intervention | 22.0 (7.47) | 16.3(7.43) | 12.0 (7.36) | – | 0.95 | |
Placebo | 21.9 (8.34) | 14.1(8.20) | 9.4 (7.41) | – | |||
Control | 23.0 (8.01) | 16.6(9.51) | 13.1 (9.29) | – | |||
Total group | 22.3 (7.88) | 15.7 (8.40) | 11.5 (8.12) | 0.00 | |||
Cortisol (pg/mg) | Intervention | 32.2 (38.48) | – | 39.1 (44.38) | – | 0.40 | |
Placebo | 38.8 (85.58) | – | 30.1 (26.71) | – | |||
Control | 20.5 (15.44) | – | 30.0 (19.36) | – | |||
Total group | 29.9 (52.60) | 32.0 (31.09) | 0.00 | ||||
Emotional role limitation (QoL) (0–100)** | Intervention | 21.1 (28.34) | 35.6 (37.72) | 64.3 (32.62) | – | 0.96 | |
Placebo | 22.6 (27.74) | 46.4 (39.90) | 67.9 (33.31) | – | |||
Control | 17.8 (17.78) | 30.0 (36.46) | 58.3 (39.15) | – | |||
Total group | 20.5 (28.00) | 37.2 (38.18) | 63.5 (34.95) | 0.00 | |||
Social Functioning (QoL) (0–100)** | Intervention | 44.6 (30.39) | 55.6 (18.78) | 68.8 (22.69) | – | 0.71 | |
Placebo | 44.4 (23.90) | 62.1 (24.17) | 74.1 (20.67) | – | |||
Control | 41.7 (22.10) | 49.2 (23.20) | 66.5 (23.20) | – | |||
Total group | 43.5 (25.44) | 55.5 (22.53) | 69.8 (22.40) | 0.00 |