Table 2.
Primary and secondary outcomes
| EUC plus HAP (n=245)* | EUC alone (n=248)* | Adjusted mean difference (95% CI)† | p value | |
|---|---|---|---|---|
| Primary outcomes | ||||
| BDI-II score at 3 months | 19·99 (15·70) | 27·52 (13·26) | −7·57 (−10·27 to −4·86) | <0·0001 |
| Depression remission at 3 months | 147/230 (64%) | 91/236 (39%) | 1·61 (1·34 to 1·93) | <0·0001 |
| Secondary outcomes | ||||
| Disability score | 9·12 (9·34) | 11·79 (8·99) | −2·73 (−4·39 to −1·06) | 0·001 |
| Days unable to work | 4·97 (7·71) | 7·21 (9·38) | −2·29 (−3·84 to −0·73) | 0·004 |
| Behavioural activation score | 12·05 (4·76) | 9·88 (4·36) | 2·17 (1·34 to 3·00) | <0·0001 |
| Suicidal thoughts or attempts‡ | 48/230 (21%) | 82/236 (35%) | 0·61 (0·45 to 0·83) | 0·001 |
| Intimate partner physical violence (women)§ | 13/112 (12%) | 26/120 (22%) | 0·53 (0·29 to 0·96) | 0·04 |
| Intimate partner psychological or emotional violence (women)§ | 33/112 (29%) | 44/120 (37%) | 0·76 (0·53 to 1·10) | 0·15 |
| Intimate partner physical violence (men)§ | 0/37 | 3/40 (8%) | 0·00 | 0·24¶ |
| Intimate partner psychological or emotional violence (men)§ | 6/37 (16%) | 8/40 (20%) | 0·67 (0·27 to 1·71) | 0·41 |
Data are mean (SD) or n/N (%). EUC=enhanced usual care. HAP=Healthy Activity Program. BDI=Beck Depression Inventory.
*
Among those with observed data at 3 months.
†
Including imputed outcome data for those with missing data.
‡
We assessed suicidal thoughts over the past 2 weeks through the relevant Patient Health Questionnaire 9 item, whereas we assessed suicide attempts over the 3 month period since enrolment. Seven participants reported suicide attempts (three in the EUC group and four in the EUC plus HAP group). All of these participants also reported suicidal thoughts.
§
Among married participants.
¶
Because of sparse data, the p value for physical violence in men is using Fisher's exact test on complete case data.