Table 3

Between-group comparisons of the changes in the primary, key secondary and exploratory outcomes from baseline to 12-month follow-up for the per-protocol population*

nInterventionnStandard careDifference or ORP value
Primary outcome
 SF-36 PCS (points)340.9 (−0.9 to 2.8)26−2.2 (−4.4 to −0.1)3.1 (0.3 to 6.0)0.031
Key secondary outcomes
 SF-36 PCS responders, n (%)†349 (26)266 (23)3.32 (0.50 to 21.90)‡0.212
 SF-36 MCS (points)342.2 (−0.2 to 4.6)260.4 (−2.3 to 3.2)1.8 (−1.9 to 5.4)(0.334)
 SF-36 MCS responders, n (%)†349 (26)269 (35)1.04 (0.10 to 10.96)‡(0.976)
Other exploratory outcomes
 MHC-SF (points)341.4 (−1.1 to 3.8)261.6 (−1.1 to 4.4)−0.3 (−4.0 to 3.4)(0.883)
 Languishing, n (%)320 (0)250 (0)NA
 Moderately mentally healthy, n (%)5 (16)6 (24)0.26 (0.04 to 1.88)§(0.183)
 Flourishing, n (%)27 (84)19 (76)3.28 (0.41 to 25.95)§(0.261)
 WEMWBS (points)322.8 (1.6 to 4.0)252.3 (1.0 to 3.7)0.5 (−1.3 to 2.3)(0.569)
 SF-36 Physical functioning (points)341.6 (0.5 to 2.6)26−0.9 (−2.1 to 0.4)2.4 (0.8 to 4.1)(0.004)
 SF-36 Physical role functioning (points)341.0 (−1.2 to 3.1)26−2.5 (−4.9 to 0.0)3.4 (0.1 to 6.7)(0.043)
 SF-36 Bodily pain (points)34−2.3 (−5.1 to 0.4)26−3.6 (−6.7 to −0.4)1.2 (−2.9 to 5.3)(0.563)
 SF-36 General health (points)345.0 (3.2 to 6.8)260.3 (−1.8 to 2.3)4.8 (2.0 to 7.5)(0.001)
 SF-36 Vitality (points)343.3 (0.8 to 5.8)26−0.6 (−3.5 to 2.3)3.9 (0.0 to 7.8)(0.048)
 SF-36 Social functioning (points)340.4 (−1.7 to 2.5)26−0.2 (−2.6 to 2.3)0.6 (−2.7 to 3.8)(0.728)
 SF-36 Emotional role functioning (points)341.3 (−0.8 to 3.4)260.7 (−1.7 to 3.1)0.6 (−2.6 to 3.8)(0.722)
 SF-36 Mental health (points)342.5 (−0.3 to 5.3)26−1.5 (−4.7 to 1.7)4.1 (−0.2 to 8.3)(0.062)
 GMS Positive affect (points)332.8 (1.0 to 4.6)250.8 (−1.3 to 2.9)2.0 (−0.8 to 4.8)(0.150)
 GMS Negative affect (points)33−1.1 (−2.6 to 0.4)25−0.6 (−2.3 to 1.2)−0.5 (−2.8 to 1.8)(0.658)
  • 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 per-protocol population was defined specifically by adherence to medication and attendance to medical consultations, and for the U-TURN group, specifically, attendance to 70% or more of the prescribed exercise sessions.

  • †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.