Table 2. Unadjusted Summary Statistics of Primary Outcome and Secondary Outcomes During 24 Weeks.
| Outcome | Sertraline Hydrochloride Plus EMM (n = 71) | PE Plus Placebo (n = 67) | PE Plus Sertraline (n = 69) |
|---|---|---|---|
| Total CAPS score, mean (SD) | |||
| Week 0 (n = 207) | 75.5 (15.0) | 80.9 (13.2) | 76.0 (14.2) |
| Week 6 (n = 172) | 54.9 (21.9) | 66.9 (19.2) | 60.6 (20.9) |
| Week 12 (n = 159) | 47.4 (24.4) | 52.9 (24.9) | 47.3 (26.4) |
| Week 24 (n = 149) | 41.7 (25.7) | 51.5 (25.3) | 43.3 (27.2) |
| Total PCL score, mean (SD) | |||
| Week 0 (n = 207) | 56.2 (10.0) | 59.6 (9.6) | 56.6 (11.6) |
| Week 6 (n = 168) | 48.1 (14.4) | 51.5 (13.6) | 46.9 (16.2) |
| Week 12 (n = 154) | 42.8 (15.5) | 43.0 (14.7) | 40.5 (17.7) |
| Week 24 (n = 146) | 41.5 (16.6) | 42.3 (13.9) | 40.5 (19.2) |
| Remissiona | |||
| No. | 28 | 14 | 26 |
| % (95% CI) | 39.4 (28.0 to −51.7) | 20.9 (11.9 to 32.6) | 37.7 (26.3 to 50.2) |
| Responsea | |||
| No. | 29 | 18 | 26 |
| % (95% CI) | 40.8 (29.3 to 53.2) | 26.9 (16.8 to 39.2) | 37.7 (26.3 to 50.2) |
| Clinically meaningful changea | |||
| No. | 44 | 35 | 39 |
| % (95% CI) | 62.0 (49.7 to 73.2) | 52.2 (39.7 to 64.6) | 56.5 (44.0 to 68.4) |
Abbreviations: CAPS, Clinician-Administered PTSD Scale; EMM, enhanced medication management; PCL, PTSD checklist; PE, prolonged exposure therapy; PTSD, posttraumatic stress disorder.
a
Remission is defined as a CAPS score of 35 or less, response is defined as 50% or higher reduction in CAPS score from baseline, and clinically meaningful change is defined as a reduction of 20 points or more in the CAPS score from baseline or a CAPS score of 35 or less. All definitions are based on week 24 CAPS scores or the last observed CAPS scores if week 24 scores are missing, and participants were considered nonremitted, not responsive, and without clinically meaningful change if all follow-up CAPS scores were missing.