Table 3. Subgroup analyses.
| MDI ≥15* | Statistical analyses | TAU: baseline(mean, SD) | TAU: follow up(mean, SD) | TAU: Baseline vsfollow up, P | Active group:baseline(mean SD) | Active group:follow up(mean, SD) | Active group:baseline vs follow up, P | Three monthfollow upTAU vs active, P | Effect size |
| MDI | ITT | 20.5 (6.59) | 16.1 (8.31) | <0.001 | 21.4 (6.19) | 14.2 (7.55) | 0.005 | 0.44 | 0.35 |
| PP | 19.4 (4.91) | 15.5 (8.19) | 19.3 (4.18) | 12.6 (6.86) | |||||
| WHO-5 | ITT | 39.8 (18.4) | 51.1 (22.9) | 0.015 | 41.3 (15.4) | 56.8 (16.7) | <0.001 | 0.36 | 0.21 |
| PP | 39.8 (17.5) | 51.3 (22.7) | 41.6 (17.3) | 57.1 (16.1) | |||||
| PPS | ITT | 85.0 (12.7) | 78.7 (16.5) | 0.017 | 86.1 (12.7) | 71.9 (20.4) | <0.001 | 0.23 | 0.43 |
| PP | 83.8 (12.5) | 78.1 (14.3) | 85.1 (13.1) | 72.8 (20.0) | |||||
| SF-36 physical component summary | ITT | 42.4 (8.91) | 43.2 (8.76) | 0.60 | 45.0 (10.7) | 45.7 (9.93) | 0.66 | 0.40 | 0.01 |
| PP | 42.2 (8.88) | 43.0 (8.43) | 48.9 (9.61) | 48.3 (8.32) | |||||
| SF-36 mental component summary | ITT | 42.0 (11.3) | 46.3 (8.71) | 0.14 | 38.9 (8.58) | 48.5 (11.5) | 0.001 | 0.48 | 0.52 |
| PP | 41.7 (11.0) | 44.9 (7.39) | 39.9 (10.0) | 45.5 (10.4) | |||||
| High PPS and high CSS (PPS>81 and CSS≥8)** | TAU: baseline (mean, SD) | TAU: follow up (mean, SD) | TAU: Baseline vs follow up, P | Active group: baseline (mean SD) | Active group: follow up (mean, SD) | Active group: Baseline vs follow up, P | Three month follow up TAU vs active, P | Effect size | |
| MDI | ITT | 13.3 (9.8) | 12.5 (8.6) | 0.55 | 14.3 (9.9) | 9.11 (8.30) | <0.001 | 0.15 | 0.52 |
| PP | 12.1 (7.18) | 12.1 (7.22) | 12.3 (7.90) | 8.25 (7.52) | |||||
| WHO-5 | ITT | 56.1 (21.7) | 56.6 (19.9) | 0.09 | 54.3 (22.9) | 67.0 (19.6) | <0.001 | 0.066 | 0.62 |
| PP | 57.7 (20.0) | 56.7 (18.9) | 55.2 (22.3) | 68.6 (18.2) | |||||
| PPS | ITT | 94.3 (5.62) | 83.8 (15.3) | <0.001 | 96.4 (5.31) | 77.3 (22.1) | <0.001 | 0.223 | 0.46 |
| PP | 92.8 (6.19) | 83.3 (13.1) | 95.9 (6.06) | 74.8 (23.5) | |||||
| SF-36 physical component summary | 42.4 (7.93) | 41.9 (9.50) | 0.99 | 43.3 (9.41) | 47.3 (9.75) | 0.009 | 0.044 | 0.47 | |
| 42.2 (7.64) | 42.3 (9.15) | 47.6 (7.80) | 51.8 (5.87) | ||||||
| SF-36 mental component summary | 48.6 (11.8) | 49.5 (9.38) | 0.64 | 47.3 (9.42) | 52.9 (8.92) | 0.004 | 0.199 | 0.51 | |
| 49.8 (11.0) | 49.7 (9.05) | 48.47 (9.42) | 52.1 (10.2) |
Results of questionnaires and PPS before and at three months follow up in subjects from active and treatment as usual groups. Only statistical analyses using ITT data are presented.
ITT: intention to treat; PP: per protocol; TAU: treatment as usual; MDI: major depression inventory; PPS: pressure pain sensitivity; CSS: Clinical stress signs.
*) Forty-two participants had MDI≥15 at baseline. Twenty-one were randomized to active and 21 to TAU group. Thirty-six participants, 18 active and 18 controls completed the study.
**) Fifty-nine patients had PPS>81 and CSS≥8 at baseline, corresponding to the highest 50% of both PPS and of CSS. Twenty-nine
were allocated to active treatment and 30 to TAU, of whom 24 and 26, respectively, completed the study.