Table 2.
Parameter estimates calculated with the mixed effect model for the primary outcome of the patient health questionnaire anxiety and depression scale
| Analysis type | No. of people in control group | Control group, mean (SD) | No. of people in intervention group | Intervention group, mean (SD) | Minimally adjusted mixed model analysis (95% CI)* | P value | Effect size (minimally adjusted mixed model) (95% CI) | Adjusted mixed model analysis (95% CI)† | P value | Effect size (adjusted mixed model) (95% CI) |
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (six months) | 189 | 26 (7.5) | 187 | 27 (7.8) | — | — | — | — | — | — |
| Intention to treat | 189 | 19 (9.8) | 187 | 17 (10) | −2.43 (−4.48 to −0.38) | 0.02 | 0.21 (0.03 to 0.39) | −2.26 (−4.28 to −0.23) | 0.03 | 0.21 (0.02 to 0.39) |
| Intention to treat, complete case | 112 | 18 (9.5) | 125 | 17 (10) | −1.37 (−3.60 to 0.92) | 0.23 | 0.08 (−0.05 to 0.21) | −1.45 (−3.62 to 0.79) | 0.20 | 0.09 (−0.05 to 0.22) |
| Per protocol | 85 | 17 (9.4) | 97 | 17 (11) | −1.63 (−4.27 to 1.06) | 0.23 | 0.09 (−0.06 to 0.24) | −2.00 (−4.54 to 0.56) | 0.13 | 0.12 (−0.03 to 0.27) |
| As treated | 93 | 17 (9.1) | 144 | 18 (11) | −0.98 (−3.28 to 1.37) | 0.41 | 0.05 (−0.08 to 0.18) | −1.25 (−3.50 to 1.05) | 0.29 | 0.07 (−0.06 to 0.20) |
| Sensitivity dataset | 124 | 18 (9.2) | 78 | 17 (10) | −1.82 (−4.29 to 0.70) | 0.15 | 0.10 (−0.04 to 0.24) | −2.03 (−4.45 to 0.42) | 0.11 | 0.12 (−0.02 to 0.26) |
Effect size measured with Cohen’s d.
CI=confidence interval.
*
Intervention v control condition; mixed effect linear regression model minimally adjusted for the respective baseline score and centre.
†
Intervention v control condition; mixed effect linear regression models adjusted for the respective baseline score, age, gender, history of depression or anxiety, SF-12 Physical Component Score, chronic medical disease, and no. of days between baseline assessment and randomisation.