Between-group comparisons of the changes in the primary, key secondary and exploratory outcomes from baseline to 12-month follow-up
| n | Intervention | n | Standard care | Difference or OR | P value | |
| Primary outcome | ||||||
| SF-36 PCS (points) | 64 | 0.8 (−0.7 to 2.3) | 34 | −2.4 (−4.6 to −0.1) | 3.2 (0.5 to 5.9) | 0.020 |
| Key secondary outcomes | ||||||
| SF-36 PCS responders, n (%)† | 61 | 19 (30) | 34 | 6 (18) | 4.04 (0.94 to 17.43)‡ | 0.061 |
| SF-36 MCS (points) | 64 | −0.4 (−2.5 to 1.7) | 34 | 0.6 (−2.6 to 3.7) | −1.0 (−4.8 to 2.8) | (0.600) |
| SF-36 MCS responders, n (%)† | 61 | 16 (25) | 34 | 9 (26) | 2.43 (0.32 to 18.54)‡ | (0.392) |
| Other exploratory outcomes | ||||||
| MHC-SF (points) | 63 | −0.3 (−2.4 to 1.9) | 33 | 1.3 (−1.8 to 4.5) | −1.6 (−5.4 to 2.2) | (0.405) |
| Languishing, n (%) | 58 | 3 (5) | 26 | 0 (0) | NA* | |
| Moderately mentally healthy, n (%) | 8 (14) | 7 (27) | 0.16 (0.03 to 0.87)§ | (0.034) | ||
| Flourishing, n (%) | 47 (81) | 19 (73) | 2.96 (0.53 to 16.69)§ | (0.218) | ||
| WEMWBS (points) | 58 | 2.0 (0.9 to 3.2) | 25 | 2.5 (0.8 to 4.2) | −0.4 (−2.5 to 1.6) | (0.675) |
| SF-36 Physical functioning (points) | 64 | 1.2 (0.3 to 2.1) | 34 | −1.0 (−2.3 to 0.4) | 2.2 (0.6 to 3.8) | (0.008) |
| SF-36 Physical role functioning (points) | 64 | −1.1 (−3.0 to 0.7) | 34 | −2.7 (−5.5 to 0.0) | 1.6 (−1.7 to 4.9) | (0.344) |
| SF-36 Bodily pain (points) | 64 | −1.5 (−3.6 to 0.7) | 34 | −3.9 (−7.1 to −0.7) | 2.5 (−1.4 to 6.3) | (0.203) |
| SF-36 General health (points) | 64 | 3.5 (1.9 to 5.1) | 34 | 0.2 (−2.2 to 2.6) | 3.3 (0.4 to 6.2) | (0.026) |
| SF-36 Vitality (points) | 64 | 2.0 (−0.1 to 4.1) | 34 | −0.1 (−3.2 to 3.0) | 2.1 (−1.7 to 5.9) | (0.270) |
| SF-36 Mental health (points) | 64 | 0.5 (−1.7 to 2.7) | 34 | −1.0 (−4.3 to 2.4) | 1.4 (−2.6 to 5.4) | (0.481) |
| SF-36 Emotional role functioning (points) | 64 | −1.6 (−3.5 to 0.3) | 34 | −0.0 (−2.9 to 2.8) | −1.6 (−5.0 to 1.9) | (0.377) |
| SF-36 Social functioning (points) | 64 | −1.1 (−2.8 to 0.7) | 34 | −0.2 (−2.9 to 2.4) | −0.8 (−4.0 to 2.4) | (0.616) |
| GMS Positive affect (points) | 59 | 2.3 (0.9 to 3.8) | 28 | 1.0 (−1.3 to 3.2) | 1.3 (−1.3 to 4.0) | (0.324) |
| GMS Negative affect (points) | 59 | −1.0 (−2.3 to 0.3) | 28 | −0.6 (−2.6 to 1.4) | −0.3 (−2.7 to 2.0) | (0.781) |
For continuous outcomes, estimates are adjusted least squares means (95% CI) from linear mixed models. For dichotomous outcomes, estimates are adjusted ORs (95% CI) from logistic regression with repeated measures. Group-wise estimates for dichotomous outcomes are n (%) at 12-month follow-up. P values in parentheses should be interpreted with caution, since they represent analyses performed after the gatekeeping procedure indicated discontinuation of analyses.
*The model failed to converge.
†Responders defined as participants achieving a clinically significant improvement from baseline to 12-month follow-up: PCS improvement ≥3.4 points, MCS improvement ≥4.6 points.
‡Numbers represent the adjusted OR (95% CI).
§Numbers represent the adjusted OR (95% CI) comparing current category to the two other categories combined.
GMS, global mood scale; MCS, mental component score; MHC-SF, mental health continuum-short form; NA, not applicable; PCS, physical component score; SF-36, 36-item short form health survey; WEMWBS, Warwick-Edinburgh mental well-being scale.