Table 2.
Summary statistics of results for primary and secondary outcomes at baseline and 12-month follow-up
| Binary outcomes | ETAU | SH + | RR (CI) | p-value |
|---|---|---|---|---|
| Frequency of current mental disorders | ||||
| 12 months – Intention-to-treat | 14/133 (10.53%) | 10/113 (8.85%) | 0.841 (0.389; 1.819) | 0.659 |
| 12 months – Per Protocol analysis | 14/133 (10.53%) | 4/72 (5.56%) | 0.528 (0.180; 1.544) | 0.230 |
| Incidence of any mental disorders | ||||
| 12 months – Intention-to-treat | 58/229a (25.46%) | 57/230a (24.68%) | 0.969 (0.676; 1.391) | 0.865 |
| 12 months – Per Protocol analysis | 58/229a (25.46%) | 23/117a (19.94%) | 0.783 (0.482; 1.273) | 0.324 |
| Persistence of any mental disorders | ||||
| 12 months – Intention-to-treat | 14/229a (6.10%) | 2/230a (1.08%) | 0.178 (0.026; 1.220) | 0.079 |
| 12 months – Per Protocol analysis | 14/229a (6.10%) | 1/117a (1.24%) | 0.204 (0.027; 1.513) | 0.120 |
| Continuous outcomes | Mean (s.d.) | Mean (s.d.) | Coefficient | p-value |
| GHQ score (0–12) | ||||
| Screening (n = 459) | 5.507 (2.447) | 5.619 (2.185) | – | – |
| 12 months (N = 374): Mixed model | 2.930 (3.298) | 1.782 (2.488) | −1.026 (−1.726; −0.326) | 0.004 |
| 12 months LOCF (N = 374) | 3.073 (3.312) | 2.456 (3.020) | −0.567 (−1.183; 0.050) | 0.072 |
| PCL5 score (0–80) | ||||
| Baseline (n = 459) | 22.765 (16.239) | 24.692 (16.352) | – | – |
| 12 months (N = 373): Mixed model | 14.606 (15.306) | 12.450 (15.298) | −3.219 (−6.579; 0.142) | 0.061 |
| 12 months LOCF (N = 373) | 16.350 (15.023) | 15.040 (15.615) | −2.016 (−4.839; 0.807) | 0.161 |
| PHQ9 score (0–27) | ||||
| Baseline (n = 459) | 8.384 (5.546) | 8.478 (5.816) | – | – |
| 12 months (N = 372): Mixed model | 5.810 (6.045) | 4.028 (4.522) | −1.608 (−2.850; −0.367) | 0.011 |
| 12 months LOCF (N = 372) | 6.335 (5.917) | 5.055 (5.484) | −1.193 (−2.295; −0.092) | 0.034 |
| WHO-5 score (0–100) | ||||
| Baseline (n = 459) | 47.354 (24.984) | 46.723 (23.625) | – | – |
| 12 months (N = 373): Mixed model | 52.157 (27.248) | 62.111 (23.435) | 10.051 (4.073; 16.028) | 0.001 |
| 12 months LOCF (N = 373) | 50.333 (26.673) | 58.961 (24.050) | 8.940 (3.903; 13.976) | 0.001 |
| WHODAS score (0–1) | ||||
| Baseline (n = 459) | 0.152 (0.144) | 0.148 (0.141) | – | – |
| 12 months (N = 373): Mixed model | 0.088 (0.107) | 0.072 (0.107) | −0.017 (−0.040; 0.006) | 0.144 |
| 12 months LOCF (N = 373) | 0.092 (0.123) | 0.077 (0.104) | −0.013 (−0.034; 0.007) | 0.197 |
| PSYCHLOPS score (0–20) | ||||
| Baseline (n = 432) | 13.925 (4.396) | 14.097 (4.013) | – | – |
| 12 months (N = 350): Mixed model | 10.758 (5.431) | 10.060 (5.603) | −0.647 (−2.016; 0.722) | 0.354 |
| 12 months LOCF (N = 350) | 10.959 (5.432) | 10.547 (5.595) | −0.539 (−1.632; 0.553) | 0.332 |
| PMLD score (0–68) | ||||
| Post-interventionb (n = 342) | 25.587 (12.846) | 24.174 (12.199) | – | – |
| 12 months (N = 288): Mixed model | 17.811 (11.833) | 17.428 (12.253) | 0.123 (−2.518; 2.765) | 0.927 |
| 12 months LOCF (N = 288) | 18.844 (11.489) | 18.886 (12.061) | 0.164 (−2.085; 2.413) | 0.886 |
| EQ-5D-3L | ||||
| Baseline (n = 455) | 0.706 (0.276) | 0.716 (0.280) | – | – |
| 12 months (N = 315): Mixed model | 1.460 (1.542) | 1.336 (1.607) | −0.125 (−0.544; 0.294) | 0.558 |
| 12 months LOCF (N = 315) | 1.277 (1.371) | 1.170 (1.400) | −0.099 (−0.384; 0.186) | 0.493 |
Values in bold highlight statistically significant differences. n indicates the number of observations at the first available measurement, while N represents the number of individuals used in regression.
a
Numbers are not observed but estimated.
b
Baseline not measured.