Table 2.
Unadjusted analyses of HDRS outcomes among modified intention-to-treat and per-protocol populations
| Enhanced usual care |
Psychological treatment |
|||||||
|---|---|---|---|---|---|---|---|---|
| N | Mean (SD) or N (%) |
Mean change (95%CI) from BL |
N | Mean (SD) or N (%) |
Mean change (95%CI) from BL |
RR (95%CI) | p | |
| Modified intention-to-treat population | ||||||||
| HDRS response | ||||||||
| 8 months gestation | 155 | 34 (21.9) | - | 133 | 32 (24.1) | - | 1.10 (0.72 to 1.68) | 0.669 |
| 3 months postpartum | 187 | 89 (47.6) | - | 148 | 82 (55.4) | - | 1.16 (0.94 to 1.43) | 0.153 |
| 12 months postpartum | 173 | 71 (41.0) | - | 145 | 75 (51.7) | - | 1.26 (0.99 to 1.60) | 0.057 |
| HDRS Recovery | ||||||||
| 12 months postpartum | 173 | 25 (14.5) | - | 144 | 31 (21.5) | - | 1.49 (0.92 to 2.40) | 0.102 |
| HDRS score a | ||||||||
| Baseline | 200 | 15.5 (4.69) | - | 184 | 15.7 (4.82) | - | - | |
| 8 months gestation | 155 | 12.8 (4.53) | −2.74 (−3.56 to −1.92) | 133 | 12.6 (5.51) | −2.92 (−3.86 to −1.98) | 0.97 (0.86 to 1.09) | 0.617 |
| 3 months postpartum | 187 | 10.1 (4.97) | −5.27 (−6.10 to −4.45) | 148 | 9.1 (4.58) | −6.46 (−7.37 to −5.55) | 0.89 (0.79 to 1.00) | 0.053 b |
| 12 months postpartum | 173 | 10.8 (5.07) | −4.71 (−5.65 to −3.76) | 145 | 9.5 (4.32) | −6.01 (−6.95 to −5.08) | 0.87 (0.78 to 0.99) | 0.028 c |
| Per protocol population | ||||||||
| HDRS response | ||||||||
| 8 months gestation | 83 | 17 (20.5) | - | 30 | 6 (20.0) | - | 0.98 (0.43 to 2.24) | 0.955 |
| 3 months postpartum | 151 | 76 (50.3) | - | 82 | 46 (56.1) | - | 1.11 (0.87 to 1.43) | 0.392 |
| 12 months postpartum | 163 | 68 (41.7) | - | 91 | 44 (48.4) | - | 1.16 (0.88 to 1.53) | 0.300 |
| HDRS Recovery | ||||||||
| 12 months postpartum | 90 | 14 (15.6) | - | 34 | 7 (20.6) | - | 1.32 (0.58 to 3.00) | 0.501 |
| HDRS score a | ||||||||
| 8 months gestation | 83 | 12.8 (4.83) | −2.81 (−3.96 to −1.65) | 30 | 12.3 (5.41) | −2.40 (−4.14 to −0.66) | 1.01 (0.80 to 1.26) | 0.964 |
| 3 months postpartum | 151 | 10.0 (4.94) | −5.32 (−6.27 to −4.38) | 82 | 8.5 (4.07) | −6.64 (−7.78 to −5.51) | 0.88 (0.73 to 1.06) | 0.187 |
| 12 months postpartum | 163 | 10.8 (5.07) | −4.74 (−5.73 to −3.76) | 91 | 9.1 (3.82) | −6.02 (−7.19 to −4.85) | 0.88 (0.73 to 1.06) | 0.167 |
BL=Baseline; CI = confidence intervals; HDRS=Hamilton Depression Rating Scale; IRR=incidence rate ratio; RR=risk ratio; SD= standard deviation;
a
Incident rate ratio (95%CI) reported;
b
Cohen’s d=0.21
c
p-value no longer significant after using the Benjamini-Hochberg procedure to adjust for multiple comparisons.