Table 3.
Feasibility and clinical outcome measures with treatment differences at 3 months, group mean differences and standardized effect size (standardized by the outcome score standard deviation)
| Baseline | 3 months | Change | Adjusted mean difference† (95% CI)# |
Standardized effect size | Test statistic and p value | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| n | mean (sd) | n | mean (sd) | n | mean (sd) | |||||
| Patient Satisfaction | TAU | 16 | 17.6 (3.3) | 11 | 13.2 (1.9) | 11 | −3.7 (4.3) | 4.00 (2.28, 5.28) |
1.41 |
z = 5.30 p < 0.001 |
| CaPE | 18 | 15.8 (2.4) | 16 | 16.6 (3.0) | 16 | 1.4 (2.9) | ||||
| BKAQ score | TAU | 16 | 1247 (129) | 11 | 1188 (257) | 11 | −54 (271) | 150 (−52, 322) |
0.68 |
z = 1.58 p = 0.113 |
| CaPE | 18 | 1325 (201) | 16 | 1358 (164) | 16 | 34 (231) | ||||
| MMAS-4 score | TAU | 16 | 1.3 (1.7) | 11 | 2.1 (1.5) | 11 | 0.7 (1.8) | −1.22 (−2.18, −0.14) |
−0.81 |
z = 2.37 p = 0.018 |
| CaPE | 18 | 1.7 (1.7) | 16 | 0.9 (1.4) | 16 | −0.5 (1.8) | ||||
| YMRS | TAU | 16 | 6.5 (1.2) | 11 | 10.0 (3.9) | 11 | 3.4 (3.4) | −6.0 (−8.7, 3.7) |
−1.18‡ |
z = 4.67 p < 0.001 |
| CaPE | 18 | 7.2 (1.5) | 16 | 5.1 (5.0) | 16 | −1.9 (4.2) | ||||
| BDI | TAU | 16 | 17.8 (11.5) | 11 | 19.6 (8.6) | 11 | 1.3 (13.6) | −10.3 (−16.8, −4.5) |
−1.17 |
z = 3.21 p = 0.001 |
| CaPE | 18 | 17.1 (5.3) | 16 | 9.5 (6.3) | 16 | −7.1 (9.1) | ||||
| EQ-5D Index (UK) | TAU | 16 | 7.6 (2.1) | 11 | 8.3 (1.8) | 11 | −0.1 (0.4) | 0.24 (0.10, 0.50) |
0.88 |
z = 2.47 p = 0.014 |
| CaPE | 18 | 7.4 (1.8) | 16 | 6.4 (1.3) | 16 | 0.07 (0.19) | ||||
| EQ-5D VAS | TAU | 16 | 60.6 (24.0) | 11 | 48.6 (18.2) | 11 | −9.5 (29.6_ | 26.8 (12.2, 41.8) |
1.14 |
z = 3.65 p < 0.001 |
| CaPE | 18 | 56.8 (26.7) | 16 | 75.6 (20.6) | 16 | 16.7 (29.6) | ||||
BKAQ Bipolar Knowledge and Attitudes Questionnaire, MMAS-4 measure of medication adherence, YMRS Young Mania Rating Scale, BDI Beck’s Depression Inventory, EQ-5D EuroQol-5 dimensions; Index and Visual Analogue Scale