Table 3.
Secondary outcome measures after 3 and 9 months of intervention: ITT analysis
| Outcome variable | All (N = 123) | HT (N = 45) | TM (N = 37) | PMR (N = 41) | Difference versus baseline (p) | Difference between interventions (p)e |
|---|---|---|---|---|---|---|
| Adequate relief (%) | ||||||
| Baseline | – | – | – | – | – | – |
| 3 months | 39 (32%) | 19 (42%) | 10 (27%) | 10 (24%) | – | 0.16c |
| 9 months | 53 (43%) | 24 (53%) | 13 (35%) | 16 (39%) | < 0.001 d | 0.21c |
| RCADS (total) (mean ± SD) | ||||||
| Baseline | 14.5 (8.3) | 15.9 (8.5) | 12.5 (7.9) | 14.7 (8.2) | – | 0.12b |
| 3 months | 13.8 (9.4) | 14.9 (10.1) | 12.4 (9.6) | 13.8 (8.5) | 0.53a | 0.11b |
| 9 months | 12.4 (9.0) | 13.5 (10.0) | 11.0 (8.2) | 12.3 (8.5) | 0.06a | 0.16b |
| RCADS (anxiety) (mean ± SD) | ||||||
| Baseline | 7.6 (4.8) | 8.4 (5.0) | 6.4 (4.5) | 7.6 (4.8) | – | 0.28b |
| 3 months | 7.4 (5.4) | 8.0 (5.6) | 6.5 (5.4) | 7.6 (5.2) | 0.80a | 0.24b |
| 9 months | 6.5 (5.1) | 6.9 (5.5) | 5.8 (4.8) | 6.8 (5.1) | 0.11a | 0.31b |
| RCADS (depression) (mean ± SD) | ||||||
| Baseline | 6.3 (3.6) | 6.9 (3.8) | 5.5 (3.5) | 6.4 (3.6) | – | 0.07b |
| 3 months | 5.8 (3,9) | 6.4 (4.5) | 5.2 (3.8) | 5.7 (3.4) | 0.30a | 0.16b |
| 9 months | 5.3 (3,8) | 6.0 (4.3) | 4.8 (3.3) | 5.0 (3.4) | 0.04 a | 0.15b |
| PCQ (mean ± SD) | ||||||
| Baseline | 99.4 (17.8) | 95.5 (14.2) | 101.5 (21.1) | 101,8 (17.8) | – | 0.19b |
| 3 months | 98.1 (19.9) | 97.0 (19.6) | 97.3 (21.0) | 100.1 (19.6) | 0.32a | 0.75b |
| 9 months | 97.7 (19.2) | 96.4 (20.4) | 97.6 (18.8) | 99.3 (18.4) | 0.27a | 0.78b |
| CSI (mean ± SD) | ||||||
| Baseline | 20.3 (13.7) | 22.5 (12.4) | 18.4 (15.3) | 19.6 (13.5) | – | 0.36b |
| 3 months | 17.3 (13.6) | 17.9 (13.0) | 17.3 (15.2) | 16.7 (12.9) | 0.001 a | 0.92b |
| 9 months | 15.6 (12.2) | 16.0 (12.3) | 15.5 (13.2) | 15.2 (11.5) | < 0.001 a | 0.94b |
aPaired t test
bOne-sided ANOVA
cChi-squared test
dMcNemar test
ep values were corrected for baseline differences between the groups if these were present
Italicized p-values indicate a statistically significant difference