Table 3.
Observed PROM scores, number of responders, and standardised response means by trial-arm and time-points
| Measure | ti | Intervention (I), N = 241 | Control (C), N = 120 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time-point (ti) | Dif. time-points, ti – t0 | Dif. time-points, ti – ti-1 | Time-point (ti) | Dif. time-points, ti – t0 | ||||||||||
| N (%) | Mean (SD) | N (%) | Mean (SD) | SRM | N (%) | Mean (SD) | SRM | N (%) | Mean (SD) | N (%) | Mean (SD) | SRM | ||
| PHQ-9 | t0 | 241 (100) | 14.41 (4.94) | – | – | – | – | – | – | 120 (100) | 14.18 (5.12) | – | – | – |
| t1 | 198 (82) | 9.28 (5.94) | 198 (82) | − 5.21 (5.23) | − 0.997 | 198 (82) | − 5.21 (5.23) | − 0.997 | 91 (76) | 11.58 (5.68) | 91 (76) | − 2.28 (5.13) | − 0.444 | |
| t2 | 186 (77) | 8.17 (5.70) | 186 (77) | − 6.34 (5.43) | − 1.168 | 177 (73) | − 0.92 (4.26) | − 0.216 | – | – | – | – | – | |
| t3 | 182 (76) | 7.17 (5.83) | 182 (76) | − 7.12 (5.90) | − 1.206 | 169 (70) | − 0.82 (5.20) | − 0.157 | – | – | – | – | – | |
| t4 | 177 (73) | 6.81 (5.71) | 177 (73) | − 7.49 (5.94) | − 1.261 | 167 (69) | − 0.42 (4.88) | − 0.086 | – | – | – | – | – | |
| t5 | 173 (72) | 6.79 (5.54) | 173 (72) | − 7.56 (6.38) | − 1.184 | 161 (67) | − 0.10 (4.72) | − 0.021 | – | – | – | – | – | |
| GAD-7 | t0 | 241 (100) | 12.66 (4.69) | – | – | – | – | – | – | 120 (100) | 12.54 (4.18) | – | – | – |
| t1 | 198 (82) | 8.20 (5.31) | 198 (82) | − 4.50 (5.17) | − 0.870 | 198 (82) | − 4.50 (5.17) | − 0.870 | 91 (76) | 10.79 (5.12) | 91 (76) | − 1.63 (4.71) | − 0.345 | |
| t2 | 186 (77) | 7.38 (5.32) | 186 (77) | − 5.20 (5.37) | − 0.968 | 177 (73) | − 0.58 (4.04) | − 0.144 | – | – | – | – | – | |
| t3 | 182 (76) | 6.93 (5.52) | 182 (76) | − 5.48 (5.98) | − 0.916 | 169 (70) | − 0.28 (4.85) | − 0.057 | – | – | – | – | – | |
| t4 | 176 (73) | 6.48 (5.14) | 176 (73) | − 5.95 (5.87) | − 1.013 | 166 (69) | − 0.35 (4.60) | − 0.076 | – | – | – | – | – | |
| t5 | 173 (72) | 6.08 (4.81) | 173 (72) | − 6.56 (5.87) | − 1.116 | 160 (66) | − 0.65 (4.35) | − 0.150 | – | – | – | – | – | |
| EQ-5D-5L | t0 | 238 (99) | 0.735 (0.152) | – | – | – | – | – | – | 117 (98) | 0.722 (0.182) | – | – | – |
| VSE | t1 | 198 (82) | 0.794 (0.147) | 196 (81) | 0.058 (0.133) | 0.435 | 196 (81) | 0.058 (0.133) | 0.435 | 91 (76) | 0.756 (0.181) | 89 (74) | 0.029 (0.138) | 0.212 |
| t2 | 186 (77) | 0.816 (0.149) | 184 (76) | 0.078 (0.143) | 0.547 | 177 (73) | 0.020 (0.106) | 0.187 | – | – | – | – | – | |
| t3 | 182 (76) | 0.830 (0.171) | 180 (75) | 0.092 (0.168) | 0.544 | 169 (70) | 0.013 (0.141) | 0.095 | – | – | – | – | – | |
| t4 | 176 (73) | 0.837 (0.170) | 174 (72) | 0.096 (0.151) | 0.631 | 166 (69) | 0.002 (0.132) | 0.019 | – | – | – | – | – | |
| t5 | 172 (71) | 0.814 (0.172) | 170 (71) | 0.075 (0.167) | 0.451 | 159 (66) | − 0.007 (0.159) | − 0.044 | – | – | – | – | – | |
| EQ-5D-5L | t0 | 238 (99) | 0.656 (0.193) | – | – | – | – | – | – | 117 (98) | 0.645 (0.218) | – | – | – |
| cross-walk | t1 | 198 (82) | 0.723 (0.182) | 196 (81) | 0.065 (0.178) | 0.366 | 196 (81) | 0.065 (0.178) | 0.366 | 91 (76) | 0.676 (0.231) | 89 (74) | 0.020 (0.172) | 0.118 |
| t2 | 186 (77) | 0.753 (0.180) | 184 (76) | 0.090 (0.182) | 0.496 | 177 (73) | 0.023 (0.136) | 0.171 | – | – | – | – | – | |
| t3 | 182 (76) | 0.767 (0.212) | 180 (75) | 0.105 (0.217) | 0.483 | 169 (70) | 0.019 (0.178) | 0.104 | – | – | – | – | – | |
| t4 | 176 (73) | 0.779 (0.204) | 174 (72) | 0.112 (0.196) | 0.573 | 166 (69) | 0.007 (0.165) | 0.040 | – | – | – | – | – | |
| t5 | 172 (71) | 0.751 (0.201) | 170 (71) | 0.092 (0.215) | 0.430 | 159 (66) | − 0.009 (0.193) | − 0.046 | – | – | – | – | – | |
| ReQoL-UI | t0 | 237 (98) | 0.788 (0.123) | – | – | – | – | – | – | 116 (97) | 0.757 (0.171) | – | – | – |
| t1 | 198 (82) | 0.810 (0.140) | 195 (81) | 0.020 (0.141) | 0.138 | 195 (81) | 0.020 (0.141) | 0.138 | 91 (76) | 0.793 (0.163) | 88 (73) | 0.025 (0.139) | 0.181 | |
| t2 | 186 (77) | 0.836 (0.151) | 183 (76) | 0.045 (0.152) | 0.295 | 177 (73) | 0.022 (0.139) | 0.162 | – | – | – | – | – | |
| t3 | 182 (76) | 0.840 (0.144) | 179 (74) | 0.050 (0.166) | 0.303 | 169 (70) | 0.002 (0.145) | 0.015 | – | – | – | – | – | |
| t4 | 176 (73) | 0.863 (0.124) | 173 (72) | 0.070 (0.117) | 0.599 | 166 (69) | 0.019 (0.142) | 0.131 | – | – | – | – | – | |
| t5 | 172 (71) | 0.850 (0.135) | 169 (70) | 0.065 (0.138) | 0.471 | 159 (66) | − 0.006 (0.127) | − 0.049 | – | – | – | – | – | |
| ReQoL-10 | t0 | 237 (98) | 18.52 (6.24) | – | – | – | – | – | – | 116 (97) | 18.76 (6.75) | – | – | – |
| t1 | 198 (82) | 21.00 (6.85) | 195 (81) | 2.20 (6.17) | 0.357 | 195 (81) | 2.20 (6.17) | 0.357 | 91 (76) | 20.25 (6.40) | 88 (73) | 0.93 (6.17) | 0.151 | |
| t2 | 186 (77) | 24.10 (7.36) | 183 (76) | 5.37 (7.43) | 0.723 | 177 (73) | 3.04 (6.46) | 0.471 | – | – | – | – | – | |
| t3 | 182 (76) | 24.59 (7.90) | 179 (74) | 5.79 (7.95) | 0.728 | 169 (70) | 0.27 (7.52) | 0.036 | – | – | – | – | – | |
| t4 | 176 (73) | 25.49 (8.20) | 173 (72) | 6.66 (7.71) | 0.863 | 166 (69) | 0.92 (6.88) | 0.134 | – | – | – | – | – | |
| t5 | 172 (71) | 24.54 (8.31) | 169 (70) | 6.00 (7.50) | 0.801 | 159 (66) | − 0.66 (7.35) | − 0.090 | – | – | – | – | – | |
| EQ-5D-5L | t0 | 238 (99) | 3.27 (0.83) | – | – | – | – | – | – | 117 (98) | 3.23 (0.82) | – | – | – |
| depression | t1 | 198 (82) | 2.64 (0.94) | 196 (81) | − 0.62 (0.95) | − 0.649 | 196 (81) | − 0.62 (0.95) | − 0.649 | 91 (76) | 2.91 (1.01) | 89 (74) | − 0.29 (0.87) | − 0.336 |
| /anxiety | t2 | 186 (77) | 2.44 (0.87) | 184 (76) | − 0.78 (0.99) | − 0.784 | 177 (73) | − 0.16 (0.84) | − 0.195 | – | – | – | – | – |
| item | t3 | 182 (76) | 2.30 (0.96) | 180 (75) | − 0.96 (1.08) | − 0.883 | 169 (70) | − 0.15 (0.97) | − 0.159 | – | – | – | – | – |
| t4 | 176 (73) | 2.23 (0.99) | 174 (72) | − 1.02 (1.06) | − 0.958 | 166 (69) | − 0.08 (0.91) | − 0.086 | – | – | – | – | – | |
| t5 | 172 (71) | 2.31 (0.98) | 170 (71) | − 0.95 (1.06) | − 0.897 | 159 (66) | 0.04 (0.90) | 0.049 | – | – | – | – | – | |
t = time point, whereby: t0 = baseline; t1 = 8 weeks; t2 = 3 months; t3 = 6 months; t4 = 9 months; t5 = 12 months
N(%) states the number of people who completed the measure at the specific time-point, or at two given time-points e.g. relative to t0 (baseline) or ti (whereby i is any time-point denoted as 1–5)
Cohen’s SRM cut-off: < 0.2, trivial; 0.2 < 0.5, small; 0.5 < 0.8, medium; ≥ 0.8, large; an SRM of > 1 means the change in score between time-points is larger than one standard deviation
EQ-5D-5L EQ-5D Five Level version, GAD-7 generalised anxiety disorder-7, N number of people, ReQoL-UI(-10) Recovering Quality of Life—Utility Index (10 item), PHQ-9 Patient Health Questionnaire-9, SD standard deviation, SRM standardised response mean