Table 3.
Primary and secondary outcomes at baseline, 12 weeks, and 26 weeks follow-up
| Baseline | 12 weeks | 26 weeks | ||||||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| n | Mean score (SD) | n | Mean score (SD) | Mean adjusted differencea (95% CI); P-value | n | Mean score (SD) | Mean adjusted differencea (95% CI); P-value | |
| Depression (BDI-II score) | ||||||||
| Intervention | 302 | 24.1 (8.96) | 252 | 18.5 (10.17) | −0.46 (−2.16 to 1.26); P = 0.602 | 226 | 15.1 (10.84) | −1.63 (−3.48 to 0.21); P = 0.082 |
| Control | 227 | 22.4 (9.52) | 195 | 16.9 (10.30) | REF | 184 | 14.7 (10.65) | REF |
|
| ||||||||
| Social functioning (WSAS score) | ||||||||
| Intervention | 302 | 17.3 (9.94) | 237 | 14.7 (9.54) | 0.48 (−1.03 to 2.00); P = 0.531 | 212 | 11.6 (9.59) | 1.34 (−3.20 to 0.53); P = 0.160 |
| Control | 227 | 16.6 (10.06) | 195 | 13.2 (9.90) | REF | 183 | 12.0 (9.99) | REF |
|
| ||||||||
| Quality of Life (EQ-5D-5L score) | ||||||||
| Intervention | 302 | 0.659 (0.232) | 256 | 0.694 (0.236) | −0.002 (−0.0412 to 0.0372) P = 0.94 | 221 | 0.718 (0.249) | 0.053 (0.013 to 0.093); P = 0.01 |
| Control | 226 | 0.667 (0.226) | 197 | 0.708 (0.213) | REF | 183 | 0.696 (0.225) | REF |
|
| ||||||||
| Satisfaction with care (MISS total score) | ||||||||
| Intervention | 302 | N/A | N/A | 217 | 121.8 (27.37) | 5.39 (−1.39 to 12.16); P = 0.119 | ||
| Control | 227 | N/A | N/A | 176 | 116.0 (26.75) | REF | ||
Adjusted for baseline value, baseline anxiety (GAD-7 score), sociodemographics, past history of depression, and practice as a random effect. BDI-II = Beck Depression Inventory, Second Edition. GAD-7 = Generalised Anxiety Disorder questionnaire. MISS = Medical Interview Satisfaction Scale. REF = reference value. WSAS = Work and Social Adjustment Scale.
One patient withdrew immediately after enrolment and did not complete an EQ-5D-5L at baseline.