Table 5.
Participant-reported mental and physical health outcomes at 5-month and 8-month follow-up
| Outcome variable | 5 months | 8 months | ||||
|---|---|---|---|---|---|---|
| UC, N = 14 | EPC, N = 13 | Mean difference or ORa (95% CI) | UC, N = 8 | EPC, N = 9 | Mean difference or ORa (95% CI) | |
| BDI-II; mean (SD), n | 7.4 (3.7), 14 | 10.2 (8.4), 12 | 1.7 (− 3.8, 7.3) | 7.0 (3.5), 8 | 12.6 (6.6), 9 | 4.4 (− 1.4, 10.2) |
| 50% reduction in BDI-II from baseline; n/N (%) | 7/14 (50) | 5/12 (42) | 0.71 (0.16, 3.25) | 4/8 (50) | 2/9 (22) | 0.29 (0.04, 2.09) |
| Remission (< 14 BDI-II) from baselineb; n/N (%) | 6/7 (86) | 3/7 (43) | 0.13 (0, 1.37) | 4/4 (100) | 2/5 (40) | 0 (0, 1.10) |
| BDI-II MCID (17.5% reduction post baseline); n/N (%) | 11/14 (79) | 10/12 (83) | 1.36 (0.22, 8.31) | 5/8 (63) | 6/9 (67) | 1.20 (0.18, 7.99) |
| BDII-II CSRC from baselinec; n/N (%) | 3/7 (43) | 2/7 (29) | 0.53 (0.07, 4.33) | 2/4 (50) | 1/5 (20) | 0.25 (0, 3.56) |
| BAI; mean (SD), n | 9.2 (4.0), 14 | 14.7 (8.3), 13 | 4.6 (− 0.8, 10.0) | 6.4 (4.6), 8 | 12.7 (7.1), 9 | 5.0 (− 1.2, 11.1) |
| EQ-5D-5 L; mean (SD), n | 0.875 (0.115), 13 | 0.885 (0.065), 13 | 0.045 (− 0.023, 0.113) | 0.876 (0.092), 8 | 0.827 (0.116), 9 | − 0.041 (− 0.145, 0.064) |
| EQ-5D VAS, mean (SD), n | 72 (21), 14 | 72 (21), 12 | 5 (− 13, 22) | 64 (18), 7 | 64 (12), 8 | 1 (− 17, 19) |
| HeartQoL; mean (SD) | 31.5 (4.9), 14 | 22.9 (10.3), 13 | − 8.2 (− 14.9, − 1.4) | 28.3 (6.7), 8 | 28.6 (7.6), 9 | 0.1 (− 7.9, 8.0) |
BAI Beck Anxiety Inventory, BDI-II Beck Depression Inventory, CI confidence interval, CSRC clinically significant and reliable change, EPC Enhanced Psychological Care, EQ-5D L EuroQoL Index, MCID minimally clinical important difference, OR odds ratio, SD standard deviation, UC usual care, VAS Visual Analogue Scale
aBetween-group comparison. The mean difference is adjusted for baseline score. No adjustments for clustering were made
bAt baseline, 7/14 UC participants and 10/15 EPC participants had a BDI-II score ≥ 14; participants with scores ≤ 13 at baseline excluded
cClinically significant and reliable change can only be calculated for participants with a baseline BDI-II score of ≥ 14