Table 2.
Baseline and post 8-week data on psychological outcome measures in intent-to-treat population (n = 79).
| Outcome variable | Probiotic |
Placebo |
Difference [95% CI] | p | ESb d | ||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline mean (SD) | Post mean (SD) | Change from baselinea | Baseline mean (SD) | Post mean (SD) | Change from baselinea | ||||
| MADRS | 28.3 (6.1) | 19.3 (8.9) | −8.7 | 27.0 (6.3) | 17.6 (9.5) | −9.7 | −1.0 [−4.9, 3.0] | 0.62 | 0.11 |
| iCGI-S | 3.8 (0.5) | 2.9 (1.1) | −0.9 | 3.66 (0.6) | 2.7 (1.0) | −0.9 | −0.1 [−0.5, 0.4] | 0.75 | 0.07 |
| iCGI-Ic | 2.4 (2.2) | 2.4 | 2.7 (2.0) | 2.7 | −0.3 [−1.2, 0.6] | 0.52 | 0.16 | ||
| QIDS-SR16 | 15.2 (3.9) | 8.5 (5.5) | −6.3 | 13.2 (3.8) | 8.0 (4.8) | −5.6 | 0.7 [−1.5, 2.8] | 0.53 | 0.15 |
| GAF | 61.2 (5.6) | 67.5 (8.5) | 6.0 | 63.1 (5.4) | 69.3 (7.1) | 6.6 | 0.7 [−2.6, 3.9] | 0.68 | 0.1 |
| DASS | 64.3 (23.9) | 37.9 (29.0) | −23.4 | 50.0 (20.6) | 29.5 (20.8) | −23.6 | −0.2 [−10.6, 10.1] | 0.97 | 0.01 |
| Depression | 24.2 (9.1) | 13.2 (11.6) | −9.9 | 19.0 (10.5) | 10.3 (8.8) | −9.9 | −0.03 [−4.1, 4.1] | 0.99 | 0.003 |
| Anxiety | 15.2 (10.4) | 8.9 (9.6) | −5.2 | 10.6 (6.6) | 6.0 (6.0) | −5.7 | −0.4 [−3.5, 2.6] | 0.78 | 0.07 |
| Stress | 25.0 (9.2) | 15.9 (10.4) | −8.1 | 20.4 (8.4) | 13.2 (8.3) | −8.3 | −0.2 [−4.0, 3.6] | 0.92 | 0.02 |
ES: effect size; MADRS: Montgomery–Åsberg Depression Rating Scale; iCGI: improved Clinical Global Impression Scale (Severity/Improvement scale); QIDS-SR16: Quick Inventory of Depressive Symptoms; GAF: Global Assessment of Functioning; DASS: Depression, Anxiety and Stress Scale.
a
Adjusted for baseline.
b
Cohen’s d effect size: measured as the mean difference in change divided by the pooled standard deviation of the change, based on values adjusted for baseline.
c
Assesses change only, therefore not measured at baseline.