Results of the causal effects (efficacy) analyses
| DHE | CG | Crude | ITT | CACE | ||||||||||||||||
| Time | n | Mean | SD | Min | Q1 | Median | Q3 | Max | n | Mean | SD | Min | Q1 | Median | Q3 | Max | Unadjusted MD* or RoM† (95% CI) | Adjusted MD* or RoM† (95% CI) | Adjusted MD* or RoM† (95% CI) | |
| WHO-5* | Baseline | 386 | 13.1 | 5.1 | 0.0 | 9.0 | 13.0 | 17.0 | 25.0 | 377 | 12.6 | 5.3 | 0.0 | 9.0 | 13.0 | 17.0 | 25.0 | 0.43 (−0.31 to 1.17) | Reference | Reference |
| Week 1 | 246 | 14.6 | 5.3 | 0.0 | 10.0 | 15.0 | 19.0 | 25.0 | 227 | 14.0 | 5.6 | 2.0 | 9.0 | 14.0 | 18.5 | 25.0 | 0.60 (−0.38 to 1.58) | 0.42 (−0.43 to 1.27) | 0.11 (−1.15 to 1.37) | |
| Week 2 | 219 | 15.0 | 5.5 | 1.0 | 11.0 | 15.0 | 20.0 | 25.0 | 206 | 14.1 | 5.3 | 1.0 | 11.0 | 14.5 | 18.8 | 25.0 | 0.91 (−0.13 to 1.94) | 0.73 (−0.10 to 1.56) | 0.28 (−1.03 to 1.58) | |
| Week 3 | 198 | 15.4 | 5.7 | 0.0 | 11.0 | 16.0 | 20.0 | 25.0 | 176 | 14.7 | 5.5 | 1.0 | 11.0 | 15.0 | 19.0 | 25.0 | 0.68 (−0.46 to 1.81) | 0.68 (−0.17 to 1.52) | 0.81 (−0.61 to 2.22) | |
| Week 4 | 186 | 16.2 | 5.5 | 0.0 | 12.0 | 17.0 | 20.0 | 25.0 | 157 | 15.1 | 5.5 | 2.0 | 11.0 | 16.0 | 20.0 | 25.0 | 1.02 (−0.16 to 2.19) | 0.99 (0.13 to 1.86)‡ | 0.07 (−1.43 to 1.56) | |
| Week 5 | 156 | 13.6 | 5.6 | 5.0 | 10.0 | 13.0 | 17.0 | 30.0 | 145 | 14.4 | 5.3 | 5.0 | 10.0 | 14.0 | 19.0 | 26.0 | −0.75 (−1.98 to 0.48) | −0.66 (−1.59 to 0.27) | −0.04 (−1.75 to 1.67) | |
| Week 6 | 140 | 13.8 | 5.6 | 5.0 | 10.0 | 13.0 | 16.3 | 29.0 | 126 | 14.1 | 5.2 | 5.0 | 10.0 | 13.0 | 17.8 | 28.0 | −0.29 (−1.60 to 1.01) | −0.22 (−1.24 to 0.81) | −0.24 (−2.20 to 1.71) | |
| Week 7 | 129 | 13.5 | 5.8 | 5.0 | 10.0 | 12.0 | 16.0 | 29.0 | 115 | 13.7 | 5.4 | 5.0 | 10.0 | 13.0 | 17.0 | 27.0 | −0.20 (−1.62 to 1.22) | −0.14 (−1.27 to 0.99) | −0.23 (−2.40 to 1.93) | |
| Week 8 | 120 | 13.1 | 5.4 | 5.0 | 10.0 | 11.5 | 16.0 | 29.0 | 108 | 13.5 | 5.7 | 5.0 | 10.0 | 12.5 | 17.3 | 27.0 | −0.49 (−1.95 to 0.97) | −0.24 (−1.49 to 1.01) | −0.34 (−2.75 to 2.06) | |
| GAD-7† | Baseline | 386 | 7.2 | 5.4 | 0.0 | 3.0 | 6.0 | 11.0 | 21.0 | 377 | 6.9 | 4.9 | 0.0 | 3.0 | 6.0 | 10.0 | 21.0 | 1.05 (0.94 to 1.16) | Reference | Reference |
| Week 1 | 249 | 6.4 | 5.3 | 0.0 | 2.0 | 5.0 | 9.0 | 22.0 | 230 | 6.7 | 5.2 | 0.0 | 3.0 | 6.0 | 9.0 | 27.0 | 0.95 (0.82 to 1.10) | 0.93 (0.83 to 1.04) | 0.99 (0.84 to 1.17) | |
| Week 2 | 221 | 5.6 | 5.2 | 0.0 | 2.0 | 4.0 | 8.0 | 21.0 | 208 | 6.3 | 4.5 | 0.0 | 3.0 | 6.0 | 9.0 | 20.0 | 0.88 (0.75 to 1.03) | 0.87 (0.77 to 0.98)‡ | 0.90 (0.74 to 1.09) | |
| Week 3 | 201 | 5.4 | 5.0 | 0.0 | 2.0 | 4.0 | 8.0 | 21.0 | 177 | 5.5 | 4.7 | 0.0 | 2.0 | 5.0 | 8.0 | 21.0 | 0.98 (0.82 to 1.17) | 0.95 (0.83 to 1.08) | 0.96 (0.77 to 1.20) | |
| Week 4 | 189 | 5.5 | 5.5 | 0.0 | 1.0 | 4.0 | 8.0 | 21.0 | 161 | 5.2 | 4.4 | 0.0 | 2.0 | 4.0 | 7.0 | 21.0 | 1.05 (0.86 to 1.27) | 0.96 (0.84 to 1.11) | 0.87 (0.68 to 1.11) | |
| Week 5 | 158 | 5.2 | 5.4 | 0.0 | 1.0 | 4.0 | 7.0 | 21.0 | 146 | 4.8 | 4.3 | 0.0 | 2.0 | 4.0 | 6.0 | 21.0 | 1.08 (0.86 to 1.34) | 0.98 (0.84 to 1.15) | 1.00 (0.75 to 1.32) | |
| Week 6 | 141 | 4.8 | 5.2 | 0.0 | 1.0 | 3.0 | 7.0 | 21.0 | 127 | 4.7 | 4.2 | 0.0 | 1.0 | 4.0 | 7.0 | 20.0 | 1.03 (0.81 to 1.30) | 0.98 (0.82 to 1.16) | 0.88 (0.64 to 1.22) | |
| Week 7 | 129 | 4.6 | 4.9 | 0.0 | 1.0 | 3.0 | 7.0 | 20.0 | 116 | 4.6 | 4.5 | 0.0 | 1.0 | 3.0 | 6.0 | 21.0 | 1.01 (0.78 to 1.31) | 0.93 (0.77 to 1.13) | 0.97 (0.68 to 1.38) | |
| Week 8 | 118 | 4.6 | 5.1 | 0.0 | 0.0 | 3.0 | 7.0 | 21.0 | 110 | 4.9 | 4.4 | 0.0 | 2.0 | 4.0 | 7.0 | 20.0 | 0.94 (0.72 to 1.22) | 0.87 (0.71 to 1.07) | 0.86 (0.58 to 1.28) | |
| SKK* | Baseline | 386 | 4.2 | 2.7 | −8.3 | 2.3 | 4.3 | 6.0 | 10.0 | 377 | 4.5 | 2.7 | −5.3 | 3.0 | 4.7 | 6.3 | 10.0 | −0.27 (−0.65 to 0.12) | Reference | Reference |
| Week 1 | 249 | 4.3 | 2.6 | −3.7 | 2.7 | 4.7 | 6.0 | 10.0 | 229 | 4.5 | 2.6 | −4.7 | 3.0 | 4.7 | 6.3 | 10.0 | −0.17 (−0.64 to 0.30) | −0.06 (−0.51 to 0.39) | −0.33 (−0.98 to 0.33) | |
| Week 2 | 220 | 5.9 | 5.5 | −4.3 | 3.0 | 5.0 | 7.0 | 30.0 | 208 | 5.5 | 4.9 | −4.0 | 2.7 | 4.7 | 6.7 | 30.0 | 0.44 (−0.55 to 1.43) | 0.50 (0.02 to 0.97)‡ | 0.80 (0.06 to 1.54)‡ | |
| Week 3 | 200 | 4.4 | 3.1 | −10.0 | 2.7 | 4.7 | 6.3 | 21.0 | 177 | 4.3 | 2.8 | −4.0 | 2.3 | 4.3 | 6.0 | 10.0 | 0.09 (−0.51 to 0.70) | 0.01 (−0.49 to 0.51) | 0.29 (−0.54 to 1.12) | |
| Week 4 | 188 | 4.5 | 2.8 | −3.3 | 2.7 | 4.7 | 6.3 | 10.0 | 160 | 4.4 | 2.9 | −4.3 | 2.6 | 4.3 | 6.0 | 11.0 | 0.13 (−0.47 to 0.73) | 0.02 (−0.50 to 0.55) | 0.42 (−0.46 to 1.31) | |
| Week 5 | 158 | 4.6 | 2.8 | −4.7 | 2.8 | 4.7 | 6.3 | 10.0 | 146 | 4.2 | 2.8 | −4.7 | 2.4 | 4.0 | 6.0 | 10.0 | 0.39 (−0.24 to 1.02) | 0.12 (−0.44 to 0.67) | 0.21 (−0.78 to 1.20) | |
| Week 6 | 141 | 4.5 | 3.1 | −10.0 | 2.3 | 4.7 | 6.3 | 10.0 | 127 | 4.1 | 2.9 | −4.7 | 2.2 | 4.7 | 6.0 | 10.0 | 0.34 (−0.38 to 1.07) | 0.06 (−0.53 to 0.64) | 0.09 (−0.98 to 1.17) | |
| Week 7 | 129 | 4.5 | 2.8 | −2.3 | 2.3 | 4.7 | 6.0 | 10.0 | 116 | 4.3 | 3.0 | −4.7 | 2.3 | 4.5 | 6.1 | 10.0 | 0.23 (−0.49 to 0.95) | 0.05 (−0.56 to 0.66) | 0.12 (−1.02 to 1.25) | |
| Week 8 | 118 | 4.7 | 2.7 | −3.7 | 3.0 | 5.0 | 6.3 | 10.0 | 110 | 4.1 | 3.3 | −10.0 | 2.3 | 4.7 | 6.0 | 10.0 | 0.55 (−0.24 to 1.34) | 0.30 (−0.34 to 0.93) | 0.56 (−0.63 to 1.75) | |
| NPAQ (moderate)† | Baseline | 386 | 179.3 | 275.3 | 0.0 | 0.0 | 90.0 | 240.0 | 2880.0 | 377 | 171.7 | 229.8 | 0.0 | 0.0 | 90.0 | 230.0 | 1440.0 | 1.04 (0.85 to 1.28) | Reference | Reference |
| Week 1 | 249 | 290.0 | 354.2 | 0.0 | 60.0 | 200.0 | 400.0 | 3325.0 | 228 | 170.7 | 235.5 | 0.0 | 0.0 | 75.0 | 242.5 | 1440.0 | 1.70 (1.34 to 2.15)‡ | 1.65 (1.40 to 1.94)‡ | 1.38 (1.08 to 1.76)‡ | |
| Week 2 | 220 | 232.1 | 452.4 | 0.0 | 0.0 | 95.0 | 300.0 | 4550.0 | 206 | 127.5 | 315.0 | 0.0 | 0.0 | 0.0 | 163.8 | 3780.0 | 1.82 (1.19 to 2.79)‡ | 1.54 (1.26 to 1.87)‡ | 1.03 (0.72 to 1.46) | |
| Week 3 | 197 | 322.4 | 622.0 | 0.0 | 60.0 | 180.0 | 375.0 | 6450.0 | 177 | 187.1 | 453.1 | 0.0 | 0.0 | 110.0 | 240.0 | 5280.0 | 1.72 (1.10 to 2.70)‡ | 1.29 (1.08 to 1.54)‡ | 1.01 (0.74 to 1.37) | |
| Week 4 | 187 | 247.7 | 276.3 | 0.0 | 60.0 | 180.0 | 347.5 | 1680.0 | 156 | 193.7 | 277.2 | 0.0 | 0.0 | 120.0 | 242.5 | 2400.0 | 1.28 (0.97 to 1.69) | 1.25 (1.04 to 1.51)‡ | 1.07 (0.77 to 1.48) | |
| Week 5 | 158 | 304.2 | 499.0 | 0.0 | 60.0 | 190.0 | 395.0 | 4530.0 | 146 | 192.1 | 308.1 | 0.0 | 22.5 | 120.0 | 240.0 | 3000.0 | 1.58 (1.10 to 2.28)‡ | 1.17 (0.96 to 1.42) | 1.05 (0.73 to 1.50) | |
| Week 6 | 140 | 310.1 | 377.5 | 0.0 | 80.0 | 200.0 | 400.0 | 2520.0 | 126 | 205.9 | 313.0 | 0.0 | 30.0 | 120.0 | 270.0 | 2760.0 | 1.51 (1.08 to 2.11)‡ | 1.19 (0.96 to 1.47) | 1.10 (0.73 to 1.66) | |
| Week 7 | 129 | 311.4 | 362.5 | 0.0 | 60.0 | 200.0 | 380.0 | 2140.0 | 114 | 210.9 | 379.5 | 0.0 | 40.0 | 125.0 | 240.0 | 3600.0 | 1.48 (1.00 to 2.18)‡ | 1.37 (1.09 to 1.72)‡ | 1.14 (0.73 to 1.76) | |
| Week 8 | 118 | 336.1 | 433.4 | 0.0 | 60.0 | 200.0 | 390.0 | 2790.0 | 109 | 234.2 | 383.1 | 0.0 | 30.0 | 120.0 | 250.0 | 3000.0 | 1.44 (0.97 to 2.12) | 1.23 (0.96 to 1.57) | 1.30 (0.81 to 2.08) | |
| NPAQ (vigorous)† | Baseline | 386 | 91.3 | 231.3 | 0.0 | 0.0 | 0.0 | 90.0 | 2880.0 | 377 | 71.1 | 133.6 | 0.0 | 0.0 | 0.0 | 80.0 | 960.0 | 1.28 (0.94 to 1.76) | Reference | Reference |
| Week 1 | 249 | 131.1 | 245.2 | 0.0 | 0.0 | 50.0 | 165.0 | 2200.0 | 228 | 63.5 | 134.2 | 0.0 | 0.0 | 0.0 | 60.0 | 1200.0 | 2.06 (1.44 to 2.96)‡ | 1.31 (1.08 to 1.61)‡ | 1.09 (0.81 to 1.46) | |
| Week 2 | 220 | 91.7 | 202.7 | 0.0 | 0.0 | 0.0 | 120.0 | 1920.0 | 206 | 42.5 | 97.3 | 0.0 | 0.0 | 0.0 | 50.0 | 840.0 | 2.15 (1.40 to 3.31)‡ | 1.23 (0.97 to 1.54) | 1.24 (0.82 to 1.88) | |
| Week 3 | 197 | 160.7 | 518.3 | 0.0 | 0.0 | 60.0 | 160.0 | 5000.0 | 177 | 51.9 | 90.5 | 0.0 | 0.0 | 10.0 | 60.0 | 600.0 | 3.09 (1.84 to 5.21)‡ | 1.30 (1.04 to 1.61)‡ | 1.18 (0.82 to 1.70) | |
| Week 4 | 187 | 127.2 | 216.2 | 0.0 | 0.0 | 60.0 | 160.0 | 1680.0 | 156 | 71.4 | 115.6 | 0.0 | 0.0 | 17.5 | 105.0 | 700.0 | 1.78 (1.25 to 2.54)‡ | 1.19 (0.95 to 1.50) | 1.01 (0.68 to 1.49) | |
| Week 5 | 158 | 143.2 | 280.9 | 0.0 | 0.0 | 55.0 | 180.0 | 2670.0 | 146 | 66.3 | 107.6 | 0.0 | 0.0 | 20.0 | 97.5 | 750.0 | 2.16 (1.44 to 3.24)‡ | 1.17 (0.92 to 1.49) | 1.23 (0.80 to 1.92) | |
| Week 6 | 140 | 162.8 | 299.4 | 0.0 | 7.5 | 60.0 | 200.0 | 2520.0 | 126 | 60.2 | 87.2 | 0.0 | 0.0 | 22.0 | 94.5 | 420.0 | 2.71 (1.82 to 4.03)‡ | 1.14 (0.87 to 1.48) | 1.25 (0.77 to 2.04) | |
| Week 7 | 129 | 147.2 | 229.4 | 0.0 | 0.0 | 50.0 | 200.0 | 1320.0 | 114 | 81.2 | 130.4 | 0.0 | 0.0 | 30.0 | 120.0 | 800.0 | 1.81 (1.21 to 2.70)‡ | 1.11 (0.84 to 1.48) | 1.33 (0.79 to 2.26) | |
| Week 8 | 118 | 167.0 | 283.1 | 0.0 | 0.0 | 60.0 | 200.0 | 1860.0 | 109 | 80.1 | 156.1 | 0.0 | 0.0 | 20.0 | 120.0 | 1300.0 | 2.09 (1.29 to 3.37)‡ | 1.11 (0.81 to 1.50) | 1.42 (0.80 to 2.50) | |
| MOS Sleep Scale* | Baseline | 386 | 69.7 | 18.3 | 13.3 | 56.7 | 70.0 | 83.3 | 100.0 | 377 | 69.1 | 17.8 | 10.0 | 56.7 | 70.0 | 83.3 | 100.0 | 0.63 (−1.94 to 3.19) | Reference | Reference |
| Week 1 | 248 | 66.8 | 12.0 | 16.7 | 60.0 | 66.7 | 73.3 | 96.7 | 230 | 68.5 | 12.2 | 6.7 | 60.8 | 70.0 | 76.7 | 100.0 | −1.69 (−3.88 to 0.49) | −2.30 (−4.43 to −0.17)‡ | −3.66 (−6.77 to −0.56)‡ | |
| Week 2 | 221 | 69.3 | 10.5 | 36.7 | 63.3 | 70.0 | 76.7 | 100.0 | 208 | 68.3 | 11.0 | 23.3 | 60.0 | 70.0 | 73.3 | 100.0 | 0.97 (−1.06 to 3.01) | 0.14 (−2.05 to 2.33) | 0.23 (−3.18 to 3.63) | |
| Week 3 | 201 | 68.1 | 11.1 | 26.7 | 63.3 | 66.7 | 73.3 | 100.0 | 177 | 68.1 | 11.9 | 20.0 | 63.3 | 66.7 | 76.7 | 100.0 | 0.03 (−2.31 to 2.36) | −0.42 (−2.72 to 1.89) | −0.79 (−4.60 to 3.03) | |
| Week 4 | 189 | 68.7 | 10.1 | 33.3 | 63.3 | 70.0 | 73.3 | 100.0 | 161 | 68.8 | 10.2 | 20.0 | 63.3 | 66.7 | 73.3 | 93.3 | −0.08 (−2.22 to 2.06) | −0.26 (−2.67 to 2.14) | −0.13 (−4.23 to 3.98) | |
| Week 5 | 158 | 67.4 | 12.6 | 0.0 | 63.3 | 66.7 | 73.3 | 100.0 | 146 | 68.5 | 9.9 | 30.0 | 63.3 | 70.0 | 73.3 | 90.0 | −1.09 (−3.66 to 1.48) | −1.01 (−3.62 to 1.60) | −1.37 (−6.11 to 3.37) | |
| Week 6 | 141 | 66.1 | 13.1 | 20.0 | 63.3 | 66.7 | 73.3 | 96.7 | 127 | 67.3 | 11.9 | 13.3 | 61.7 | 66.7 | 73.3 | 100.0 | −1.17 (−4.19 to 1.85) | −1.13 (−3.98 to 1.72) | −0.55 (−5.89 to 4.80) | |
| Week 7 | 129 | 68.9 | 11.4 | 20.0 | 63.3 | 70.0 | 73.3 | 100.0 | 116 | 69.1 | 9.7 | 50.0 | 63.3 | 66.7 | 76.7 | 93.3 | −0.19 (−2.87 to 2.49) | −0.04 (−3.13 to 3.05) | −1.11 (−6.97 to 4.75) | |
| Week 8 | 118 | 70.0 | 11.2 | 30.0 | 63.3 | 70.0 | 73.3 | 100.0 | 110 | 68.0 | 11.1 | 26.7 | 63.3 | 66.7 | 73.3 | 93.3 | 2.06 (−0.86 to 4.97) | 2.26 (−1.07 to 5.60) | 7.69 (1.30 to 14.08)‡ | |
| CPGS (pain)† | Baseline | 386 | 18.9 | 18.5 | 0.0 | 3.3 | 13.3 | 30.0 | 93.3 | 377 | 16.2 | 18.0 | 0.0 | 0.0 | 10.0 | 26.7 | 80.0 | 1.17 (1.01 to 1.36)‡ | Reference | Reference |
| Week 1 | 249 | 22.6 | 20.4 | 0.0 | 6.7 | 20.0 | 36.7 | 93.3 | 230 | 18.4 | 20.8 | 0.0 | 0.0 | 10.0 | 30.0 | 90.0 | 1.23 (1.02 to 1.48)‡ | 1.02 (0.89 to 1.17) | 1.03 (0.85 to 1.26) | |
| Week 2 | 221 | 19.5 | 20.4 | 0.0 | 0.0 | 13.3 | 30.0 | 93.3 | 208 | 15.7 | 19.0 | 0.0 | 0.0 | 10.0 | 26.7 | 80.0 | 1.24 (1.00 to 1.54)‡ | 1.06 (0.91 to 1.23) | 1.27 (1.01 to 1.60)‡ | |
| Week 3 | 201 | 17.5 | 20.4 | 0.0 | 0.0 | 10.0 | 26.7 | 93.3 | 177 | 15.2 | 18.4 | 0.0 | 0.0 | 10.0 | 26.7 | 76.7 | 1.15 (0.90 to 1.46) | 1.05 (0.89 to 1.23) | 1.31 (1.00 to 1.71)‡ | |
| Week 4 | 189 | 15.0 | 18.9 | 0.0 | 0.0 | 6.7 | 23.3 | 86.7 | 161 | 14.2 | 18.4 | 0.0 | 0.0 | 6.7 | 23.3 | 80.0 | 1.06 (0.81 to 1.39) | 1.18 (0.98 to 1.41) | 1.48 (1.10 to 2.01)‡ | |
| Week 5 | 158 | 15.8 | 19.8 | 0.0 | 0.0 | 6.7 | 30.0 | 90.0 | 146 | 12.8 | 17.3 | 0.0 | 0.0 | 6.7 | 20.0 | 80.0 | 1.24 (0.92 to 1.66) | 1.18 (0.97 to 1.44) | 1.32 (0.92 to 1.88) | |
| Week 6 | 141 | 13.9 | 18.2 | 0.0 | 0.0 | 6.7 | 23.3 | 86.7 | 127 | 13.5 | 17.3 | 0.0 | 0.0 | 10.0 | 23.3 | 93.3 | 1.03 (0.75 to 1.40) | 1.04 (0.83 to 1.30) | 1.03 (0.68 to 1.54) | |
| Week 7 | 129 | 12.8 | 17.1 | 0.0 | 0.0 | 6.7 | 20.0 | 90.0 | 116 | 13.2 | 17.4 | 0.0 | 0.0 | 6.7 | 20.0 | 80.0 | 0.97 (0.69 to 1.36) | 1.05 (0.82 to 1.34) | 1.23 (0.78 to 1.95) | |
| Week 8 | 118 | 12.6 | 16.3 | 0.0 | 0.0 | 8.3 | 20.0 | 93.3 | 110 | 10.4 | 14.2 | 0.0 | 0.0 | 3.3 | 16.7 | 70.0 | 1.21 (0.85 to 1.71) | 1.18 (0.90 to 1.54) | 1.39 (0.83 to 2.31) | |
| CPGS (disability)† | Baseline | 386 | 9.0 | 16.1 | 0.0 | 0.0 | 0.0 | 10.0 | 90.0 | 377 | 7.3 | 13.7 | 0.0 | 0.0 | 0.0 | 10.0 | 83.3 | 1.23 (0.95 to 1.59) | Reference | Reference |
| Week 1 | 249 | 8.9 | 15.0 | 0.0 | 0.0 | 0.0 | 10.0 | 80.0 | 230 | 8.7 | 15.7 | 0.0 | 0.0 | 0.0 | 10.0 | 86.7 | 1.03 (0.75 to 1.41) | 1.00 (0.81 to 1.24) | 1.11 (0.82 to 1.50) | |
| Week 2 | 221 | 8.1 | 15.6 | 0.0 | 0.0 | 0.0 | 10.0 | 83.3 | 208 | 6.5 | 14.3 | 0.0 | 0.0 | 0.0 | 6.7 | 80.0 | 1.24 (0.84 to 1.83) | 1.00 (0.78 to 1.28) | 0.97 (0.66 to 1.43) | |
| Week 3 | 201 | 8.0 | 15.6 | 0.0 | 0.0 | 0.0 | 10.0 | 83.3 | 177 | 5.0 | 11.3 | 0.0 | 0.0 | 0.0 | 3.3 | 56.7 | 1.58 (1.03 to 2.43)‡ | 1.15 (0.87 to 1.53) | 1.24 (0.80 to 1.95) | |
| Week 4 | 189 | 5.8 | 14.1 | 0.0 | 0.0 | 0.0 | 6.7 | 76.7 | 161 | 5.0 | 11.0 | 0.0 | 0.0 | 0.0 | 3.3 | 63.3 | 1.17 (0.72 to 1.89) | 0.96 (0.70 to 1.30) | 0.78 (0.46 to 1.32) | |
| Week 5 | 158 | 7.3 | 16.5 | 0.0 | 0.0 | 0.0 | 6.7 | 100.0 | 146 | 5.6 | 12.8 | 0.0 | 0.0 | 0.0 | 3.3 | 60.0 | 1.29 (0.77 to 2.16) | 1.12 (0.81 to 1.56) | 1.51 (0.79 to 2.86) | |
| Week 6 | 141 | 5.2 | 13.6 | 0.0 | 0.0 | 0.0 | 0.0 | 80.0 | 127 | 5.9 | 13.3 | 0.0 | 0.0 | 0.0 | 3.3 | 66.7 | 0.88 (0.49 to 1.58) | 0.98 (0.67 to 1.43) | 0.99 (0.46 to 2.11) | |
| Week 7 | 129 | 6.7 | 17.4 | 0.0 | 0.0 | 0.0 | 3.3 | 100.0 | 116 | 5.6 | 13.2 | 0.0 | 0.0 | 0.0 | 3.3 | 70.0 | 1.20 (0.65 to 2.24) | 1.30 (0.87 to 1.95) | 1.31 (0.60 to 2.88) | |
| Week 8 | 118 | 4.0 | 9.6 | 0.0 | 0.0 | 0.0 | 3.3 | 73.3 | 110 | 3.6 | 8.9 | 0.0 | 0.0 | 0.0 | 0.0 | 56.7 | 1.11 (0.59 to 2.09) | 0.88 (0.57 to 1.37) | 0.76 (0.33 to 1.76) | |
Adjusted values were estimated with mixed models corrected for differences between groups at baseline, repeated measurements, centres (ie, countries), and the following prognostic variables at baseline that could possibly affect missing outcome data in our data set: age, sex, living environment, employment and university degree. Estimates for each time point were obtained from mixed models by including dummy variables indicating the follow-up time points 1–8 and the interaction terms composed of group and time (ie, ‘group × time’, where 0 is for CG and 1 is for DHE, and weeks 1–8) as fixed effects.
*Estimates reported as MD from the results of the linear models.
†Estimates reported as RoM from exponentiating the results of the exponential (log-linear) models.
‡CI not containing the null value.
CACE, complier average causal effect; CG, control group; CPGS, Chronic Pain Grade Scale; DHE, digital home exercise; GAD-7, Generalized Anxiety Disorder Scale-7; ITT, intention-to-treat effect; MD, mean difference; MOS, Medical Outcome Study; NPAQ, Nordic Physical Activity Questionnaire; RoM, ratio of means; SKK, Self-Concordance Scale.