Table 3.
Secondary outcomes at three months’ follow-up by treatment arm. Values are number (percentage) unless stated otherwise
| Outcomes | Intervention (n=298) | Usual care (n=287) | Total (n=585) | Adjusted estimate (95% CI)*; P value |
|---|---|---|---|---|
| EQ-5D-5L index | ||||
| No of participants | 237 | 245 | 482 | 0.02 (−0.01 to 0.05); 0.26 |
| Mean (SD) | 0.6 (0.3) | 0.6 (0.25) | 0.6 (0.3) | |
| Median (IQR) | 0.8 (0.5-0.8) | 0.65 (0.5-0.7) | 0.65 (0.5-0.7) | |
| EQ-5D-5L VAS | ||||
| No of participants | 236 | 245 | 481 | 3.37 (0.23 to 6.51); 0.04 |
| Mean (SD) | 62.3 (19.1) | 57.6 (21.6) | 59.9 (20.5) | |
| Median (IQR) | 61.5 (50.0-77.5) | 60.0 (41.0-75.0) | 60.0 (46.0-76.0) | |
| PTSD IES-R total score | ||||
| No of participants | 192 | 188 | 380 | 2.61 (0.08 to 5.14); 0.04 |
| Mean (SD) | 24.6 (18.0) | 28.1 (20.1) | 26.4 (19.1) | |
| Median (IQR) | 21.0 (11.0-35.5) | 26.0 (11.0-42.5) | 23.5 (11.0-39.5) | |
| PTSD IES-6 total score | ||||
| No of participants | 237 | 248 | 485 | |
| Score ≥11 | 79 (33) | 114 (46) | 193 (40.0) | |
| HADS anxiety | ||||
| No of participants | 212 | 214 | 426 | 0.29 (−0.37 to 0.94); 0.38 |
| Mean (SD) | 8.0 (4.8) | 8.6 (4.8) | 8.3 (4.8) | |
| Median (IQR) | 8.0 (4.0-11.0) | 8.0 (5.0-12.0) | 8.0 (5.0-12.0) | |
| Score ≥11 | 77 (34) | 85 (38) | 162 (36) | |
| HADS depression | ||||
| No of participants | 206 | 216 | 422 | 0.46 (−0.14 to 1.05); 0.13 |
| Mean (SD) | 7.7 (4.5) | 8.4 (4.8) | 8.1 (4.6) | |
| Median (IQR) | 7.0 (4.0-10.0) | 8.0 (5.0-11.0) | 8.0 (4.0-11.0) | |
| Score ≥11 | 65 (29) | 78 (35) | 143 (32) | |
| IPAQ-SF (MET min/week) | ||||
| No of participants | 221 | 222 | 443 | 1.66‡ (1.14 to 2.41); 0.01 |
| <600 (low) | 59 (27) | 76 (34) | 135 (31) | |
| ≥600-3000 (moderate) | 77 (35) | 66 (30) | 143 (32) | |
| ≥3000 (high) | 85 (38) | 80 (36) | 165 (37) | |
| Health v 3 months ago | ||||
| No of participants | 216 | 220 | 436 | 0.30 (0.13 to 0.46); 0.001 |
| Much better now | 39 (17) | 20 (8) | 59 (12) | |
| Somewhat better now | 81 (34) | 60 (24) | 141 (29) | |
| About the same | 72 (30) | 108 (44) | 180 (37) | |
| Somewhat worse | 19 (8) | 27 (11) | 46 (10) | |
| Much worse | 5 (2) | 5 (2) | 10 (2) |
EQ-5D-5L=EuroQol 5 dimension 5 level; VAS=visual analogue scale; PTSD=post-traumatic stress disorder; IES-R=index of event score-revised; HADS=hospital anxiety and depression score; PROMIS=patient reported outcomes measurement information system; IPAQ-SF=international physical activity questionnaire-short form.
Based on a partially nested heteroscedastic model adjusted for baseline overall health and stratification variables (age, level of hospital, and level of mental health disorder). The therapist effect was included as a random effect to account for partial clustering.
Odds ratio; mixed effect ordered logistic regression model. A score ≥11 for PTSD-IES-6, HADS anxiety, or HADS depression was the threshold for case level mental health disorder—these categorical data have not been statistically analysed.