Table 2.
Primary and secondary outcomes from baseline
| Intervention Change vs baseline |
Control Change vs baseline |
Between-group difference | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month | Intervention Mean ± SD |
Control Mean ± SD |
Estimate (std. error) | 95% CI | p Value | Sidak p value |
Estimate (std. error) | 95% CI | p Value | Sidak p value |
Estimate (std. error) | 95% CI | p Value | Sidak p value |
|
| BPI total [0–10] | 0 | 5.8 ± 1.9 | 5.8 ± 1.9 | ||||||||||||
| 6 | 5.6 ± 2.0 | 5.6 ± 1.9 | − 0.19 (0.16) | (− 0.51, 0.13) | 0.253 | − 0.19 (0.17) | (− 0.52, 0.14) | 0.250 | 0.01 (0.23) | (− 0.45, 0.46) | 0.981 | ||||
| 9 | 5.4 ± 2.0 | 5.3 ± 2.0 | − 0.40 (0.17) | (− 0.73, − 0.07) | 0.018 | − 0.47 (0.17) | (− 0.80, − 0.14) | 0.006 | 0.07 (0.24) | (− 0.40, 0.54) | 0.774 | ||||
| BPI severity [0–10] | 0 | 6.2 ± 1.5 | 5.9 ± 1.7 | ||||||||||||
| 6 | 5.8 ± 1.9 | 5.7 ± 1.7 | − 0.35 (0.16) | (− 0.66, − 0.05) | 0.024 | 0.048 | − 0.18 (0.16) | (− 0.50, 0.13) | 0.258 | 0.449 | − 0.17 (0.22) | (− 0.61, 0.27) | 0.444 | 0.690 | |
| 9 | 5.7 ± 1.7 | 5.6 ± 1.8 | − 0.42 (0.16) | (− 0.74, − 0.10) | 0.010 | 0.019 | − 0.36 (0.16) | (− 0.68, − 0.04) | 0.029 | 0.057 | − 0.06 (0.23) | (− 0.51, 0.39) | 0.789 | 0.955 | |
| BPI interference [0–10] | 0 | 5.7 ± 2.5 | 5.7 ± 2.4 | ||||||||||||
| 6 | 5.6 ± 2.4 | 5.5 ± 2.3 | − 0.13 (0.20) | (− 0.53, 0.27) | 0.538 | 0.787 | − 0.23 (0.21) | (− 0.64, 0.18) | 0.272 | 0.470 | 0.10 (0.29) | (− 0.47, 0.68) | 0.722 | 0.923 | |
| 9 | 5.2 ± 2.3 | 5.2 ± 2.3 | − 0.41 (0.21) | (− 0.83, 0.00) | 0.050 | 0.098 | − 0.57 (0.21) | (− 0.99, − 0.15) | 0.007 | 0.015 | 0.16 (0.30) | (− 0.43, 0.74) | 0.600 | 0.840 | |
| SF-36 general health perceptions [0–100] | 0 | 52.2 ± 20.9 | 52.8 ± 21.1 | ||||||||||||
| 6 | 52.7 ± 21.7 | 50.1 ± 19.7 | − 0.92 (1.75) | (− 4.37, 2.53) | 0.601 | 0.999 | − 3.13 (1.80) | (− 6.68, 0.41) | 0.083 | 0.702 | 2.21 (2.51) | (− 2.73, 7.16) | 0.379 | 0.999 | |
| 9 | 50.9 ± 21.5 | 51.9 ± 21.0 | − 1.96 (1.81) | (− 5.52, 1.60) | 0.279 | 0.990 | − 2.06 (1.83) | (− 5.67, 1.54) | 0.261 | 0.986 | 0.10 (2.58) | (− 4.97, 5.16) | 0.969 | 0.999 | |
| SF-36 physical function [0-100] | 0 | 45.1 ± 25.6 | 42.0 ± 22.0 | ||||||||||||
| 6 | 47.3 ± 24.4 | 41.5 ± 22.8 | 3.03 (2.00) | (− 0.90, 6.97) | 0.130 | 0.859 | − 0.69 (2.05) | (− 4.73, 3.35) | 0.736 | 0.999 | 3.73 (2.87) | (− 1.91, 9.37) | 0.195 | 0.952 | |
| 9 | 44.1 ± 24.9 | 40.7 ± 23.0 | − 1.07 (2.06) | (− 5.13, 2.99) | 0.605 | 0.999 | − 1.64 (2.09) | (− 5.75, 2.47) | 0.432 | 0.999 | 0.57 (2.94) | (− 5.20, 6.35) | 0.845 | 0.999 | |
| SF-36 role limits due to physical health [0–100] | 0 | 27.1 ± 35.9 | 19.9 ± 32.7 | ||||||||||||
| 6 | 25.8 ± 35.6 | 20.6 ± 33.5 | − 0.19 (3.57) | (− 7.20, 6.82) | 0.957 | 0.999 | 0.62 (3.68) | (− 6.61, 7.85) | 0.866 | 0.999 | − 0.81 (5.12) | (− 10.88, 9.26) | 0.874 | 0.999 | |
| 9 | 28.5 ± 36.8 | 26.5 ± 37.3 | 3.05 (3.67) | (− 4.17, 10.28) | 0.407 | 0.999 | 5.82 (3.74) | (− 1.53, 13.17) | 0.120 | 0.833 | − 2.77 (5.24) | (− 13.07, 7.54) | 0.597 | 0.999 | |
| SF-36 role limits due to emotional problems [0–100] | 0 | 56.4 ± 43.0 | 55.6 ± 44.3 | ||||||||||||
| 6 | 53.3 ± 42.5 | 48.1 ± 39.8 | − 2.85 (4.62) | (− 11.93, 6.23) | 0.537 | 0.999 | − 6.75 (4.78) | (− 16.14, 2.65) | 0.159 | 0.911 | 3.90 (6.64) | (− 9.17, 16.96) | 0.558 | 0.999 | |
| 9 | 55.3 ± 40.7 | 49.6 ± 44.8 | 0.06 (4.76) | (− 9.30, 9.41) | 0.991 | 0.999 | − 5.62 (4.85) | (− 15.17, 3.92) | 0.247 | 0.981 | 5.68 (6.80) | (− 7.68, 19.04) | 0.404 | 0.999 | |
| SF-36 energy fatigue [0–100] | 0 | 39.5 ± 24.7 | 38.0 ± 21.4 | ||||||||||||
| 6 | 40.5 ± 21.6 | 40.3 ± 18.6 | 1.47 (1.95) | (− 2.37, 5.30) | 0.451 | 0.999 | 2.09 (2.00) | (− 1.85, 6.03) | 0.297 | 0.993 | − 0.62 ( 2.80) | (− 6.12, 4.88) | 0.824 | 0.999 | |
| 9 | 38.8 ± 20.5 | 39.6 ± 22.8 | 0.65 (2.01) | (− 3.30, 4.60) | 0.747 | 0.999 | 1.16 (2.04) | (− 2.85, 5.17) | 0.569 | 0.999 | − 0.51 (2.86) | (− 6.14, 5.11) | 0.857 | 0.999 | |
| SF-36 emotional well-being [0–100] | 0 | 67.9 ± 23.1 | 70.4 ± 20.2 | ||||||||||||
| 6 | 64.7 ± 22.5 | 67.9 ± 18.7 | − 2.31 (2.07) | (− 6.39, 1.76) | 0.265 | 0.987 | − 2.30 (2.14) | (− 6.50, 1.90) | 0.282 | 0.990 | − 0.01 (2.98) | (− 5.87, 5.84) | 0.997 | 0.999 | |
| 9 | 66.6 ± 22.3 | 66.7 ± 21.2 | − 0.09 (2.14) | (− 4.29, 4.11) | 0.966 | 0.999 | − 3.44 (2.17) | (− 7.71, 0.83) | 0.114 | 0.817 | 3.35 (3.05) | (− 2.64, 9.34) | 0.272 | 0.988 | |
| SF-36 social functioning [0–100] | 0 | 57.4 ± 30.6 | 57.7 ± 29.0 | ||||||||||||
| 6 | 58.0 ± 30.0 | 59.0 ± 26.7 | 0.93 (2.79) | (− 4.55, 6.41) | 0.738 | 0.999 | 1.21 (2.87) | (− 4.44, 6.86) | 0.675 | 0.999 | - 0.27 (4.00) | (− 8.15, 7.60) | 0.945 | 0.999 | |
| 9 | 57.9 ± 30.4 | 62.0 ± 27.0 | 1.78 (2.87) | (− 3.87, 7.43) | 0.536 | 0.999 | 4.44 (2.92) | (− 1.31, 10.18) | 0.130 | 0.857 | − 2.66 (4.10) | (− 10.72, 5.40) | 0.517 | 0.999 | |
| SF-36 bodily pain [0–100] | 0 | 37.6 ± 21.9 | 39.4 ± 19.4 | ||||||||||||
| 6 | 39.9 ± 18.4 | 43.2 ± 18.9 | 2.08 (2.10) | (− 2.06, 6.21) | 0.323 | 0.996 | 3.60 (2.17) | (− 0.67, 7.86) | 0.098 | 0.765 | − 1.52 (3.02) | (− 7.46, 4.43) | 0.616 | 0.999 | |
| 9 | 41.3 ± 21.7 | 41.3 ± 21.3 | 3.22 (2.17) | (− 1.04, 7.48) | 0.138 | 0.875 | 1.83 (2.20) | (− 2.51, 6.16) | 0.408 | 0.999 | 1.39 (3.09) | (− 4.69, 7.47) | 0.653 | 0.999 | |
| Perceived Social Support [12–84] | 0 | 62.2 ± 16.5 | 62.6 ± 18.1 | ||||||||||||
| 6 | 62.0 ± 17.9 | 60.4 ± 16.4 | − 0.46 (1.34) | (− 3.10, 2.19) | 0.735 | 0.999 | − 2.07 (1.38) | (− 4.78, 0.64) | 0.135 | 0.868 | 1.61 (1.92) | (− 2.17, 5.40) | 0.403 | 0.999 | |
| 9 | 63.6 ± 17.8 | 62.1 ± 17.3 | 1.23 (1.39) | (− 1.50, 3.95) | 0.376 | 0.999 | − 0.26 (1.40) | (− 3.01, 2.50) | 0.855 | 0.999 | 1.48 (1.97) | (− 2.39, 5.36) | 0.452 | 0.999 | |
| Self-efficacy [0–10] | 0 | 6.1 ± 2.2 | 6.2 ± 2.3 | ||||||||||||
| 6 | 6.3 ± 2.3 | 6.1 ± 2.1 | 0.23 (0.23) | (− 0.22, 0.69) | 0.307 | 0.994 | − 0.15 (0.24) | (− 0.62, 0.31) | 0.523 | 0.999 | 0.39 (0.33) | (− 0.26, 1.03) | 0.243 | 0.980 | |
| 9 | 6.4 ± 2.2 | 6.1 ± 2.2 | 0.31 (0.24) | (− 0.16, 0.77) | 0.196 | 0.953 | − 0.20 (0.24) | (− 0.67, 0.27) | 0.403 | 0.999 | 0.51 (0.34) | (− 0.16, 1.17) | 0.133 | 0.864 | |
| GAD-7 anxiety [0–21] | 0 | 6.1 ± 5.3 | 6.2 ± 5.4 | ||||||||||||
| 6 | 6.9 ± 5.4 | 6.2 ± 4.9 | 1.00 (0.47) | (0.08, 1.92) | 0.033 | 0.379 | − 0.10 (0.48) | (− 1.05, 0.85) | 0.835 | 0.999 | 1.10 (0.67) | (− 0.22, 2.42) | 0.102 | 0.780 | |
| 9 | 6.5 ± 5.5 | 6.4 ± 5.3 | 0.53 (0.48) | (− 0.42, 1.48) | 0.274 | 0.989 | 0.10 (0.49) | (− 0.86, 1.07) | 0.833 | 0.999 | 0.43 (0.69) | (− 0.93, 1.78) | 0.536 | 0.999 | |
| PHQ-8 depression [0–24] | 0 | 9.3 ± 6.4 | 8.9 ± 6.0 | ||||||||||||
| 6 | 10.1 ± 6.7 | 9.1 ± 5.4 | 0.75 (0.54) | (− 0.32, 1.82) | 0.169 | 0.925 | 0.01 (0.56) | (− 1.10, 1.11) | 0.993 | 0.999 | 0.75 (0.78) | (− 0.79, 2.28) | 0.340 | 0.997 | |
| 9 | 9.2 ± 6.2 | 8.3 ± 5.8 | − 0.03 (0.56) | (− 1.13, 1.08) | 0.959 | 0.999 | − 0.73 (0.57) | (− 1.85, 0.39) | 0.203 | 0.959 | 0.70 (0.80) | (− 0.88, 2.27) | 0.384 | 0.999 | |
| Pain Catastrophizing Scale [0–52] | 0 | 20.8 ± 13.1 | 21.5 ± 13.3 | ||||||||||||
| 6 | 21.8 ± 13.8 | 22.0 ± 11.8 | 1.20 (1.16) | (− 1.09, 3.49) | 0.304 | 0.994 | 0.19 (1.19) | (− 2.16, 2.54) | 0.872 | 0.999 | 1.01 (1.67) | (− 2.27, 4.29) | 0.546 | 0.999 | |
| 9 | 19.0 ± 13.5 | 20.5 ± 12.4 | − 2.13 (1.20) | (− 4.49, 0.23) | 0.077 | 0.672 | − 1.54 (1.21) | (− 3.93, 0.84) | 0.204 | 0.959 | − 0.59 (1.71) | (− 3.95, 2.77) | 0.730 | 0.999 | |
| Patient activation measure [0–100] | 0 | 60.6 ± 13.5 | 57.9 ± 13.8 | ||||||||||||
| 6 | 63.5 ± 14.9 | 58.7 ± 14.3 | 3.68 (1.41) | (0.90, 6.46) | 0.010 | 0.126 | 0.85 (1.44) | (− 1.99, 3.68) | 0.557 | 0.999 | 2.84 (2.02) | (− 1.13, 6.80) | 0.161 | 0.914 | |
| 9 | 62.8 ± 14.7 | 60.5 ± 14.9 | 2.76 (1.45) | (− 0.09, 5.61) | 0.058 | 0.564 | 2.94 (1.46) | (0.08, 5.81) | 0.044 | 0.468 | − 0.18 (2.06) | (− 4.22, 3.86) | 0.930 | 0.999 | |
The italicized values simply indicate statistical significance at or below the p<.05 threshold