Outcome | Phase | Control | Intervention | Difference | P value | ||
---|---|---|---|---|---|---|---|
 |  | N | Mean (SD) | N | Mean (SD) | Mean (95% CI) |  |
Intention to treat analyses | |||||||
GHQ | Baseline | 463 | 5.80 (2.37) | 447 | 6.73 (2.38) | 0.92 (0.24, 1.60) | 0.008 |
 | Follow-up | 463 | 5.61 (2.58) | 447 | 5.33 (2.66) | −0.30 (−1.08, 0.48) | 0.45 |
 | Change (*) | 463 | −0.48 | 447 | −1.11 | −0.63 (−1.27, 0.01) | 0.05 |
EQ | Baseline | 447 | 0.66 (0.19) | 438 | 0.63 (0.20) | −0.04 (−0.08, 0.01) | 0.09 |
 | Follow-up | 447 | 0.66 (0.25) | 438 | 0.72 (0.19) | 0.06 (0.01, 0.11) | 0.02 |
 | Change (*) | 447 | 0.01 | 438 | 0.09 | 0.07 (0.04, 0.11) | <0.001 |
WHODAS | Baseline | 462 | 25.6 (8.9) | 437 | 29.8 (8.7) | 4.0 (1.3, 6.7) | 0.003 |
 | Follow-up | 462 | 26.8 (11.6) | 437 | 25.5 (9.2) | −1.6 (−5.1, 1.8) | 0.36 |
 | Change (*) | 462 | 0.1 | 437 | −3.1 | −3.3 (−5.8, −0.7) | 0.01 |
Per protocol analyses | |||||||
GHQ | Baseline | 418 | 5.80 (2.37) | 447 | 6.73 (2.38) | 0.91 (0.23, 1.60) | 0.009 |
 | Follow-up | 418 | 5.79 (2.54) | 447 | 5.33 (2.66) | −0.48 (−1.26, 0.29) | 0.22 |
 | Change (*) | 418 | −0.32 | 447 | −1.12 | −0.81 (−1.45, −0.17) | 0.01 |
EQ | Baseline | 398 | 0.65 (0.19) | 438 | 0.63 (0.20) | −0.02 (−0.07, 0.02) | 0.26 |
 | Follow-up | 398 | 0.65 (0.25) | 438 | 0.72 (0.19) | 0.07 (0.02, 0.13) | 0.006 |
 | Change (*) | 398 | 0.01 | 438 | 0.09 | 0.08 (0.04, 0.12) | <0.001 |
WHODAS | Baseline | 418 | 25.7 (8.9) | 437 | 29.8 (8.7) | 3.9 (1.2, 6.7) | 0.005 |
 | Follow up | 418 | 27.3 (11.8) | 437 | 25.5 (9.2) | −2.2 (−5.7, 1.4) | 0.23 |
 | Change (*) | 418 | 0.6 | 437 | −3.2 | −3.8 (−6.4, -1.2) | 0.004 |