Table 1. Demographics, Clinical Characteristics, and Adverse Eventsa.
| Characteristic | IPS (n = 271) | Transitional Work (n = 270) |
|---|---|---|
| Baseline Demographics and Clinical Characteristics | ||
| Age, mean (SD), y | 42.5 (10.7) | 41.9 (11.2) |
| Male, No. (%) | 224 (82.7) | 218 (80.7) |
| Female, No. (%) | 47 (17.3) | 52 (19.3) |
| Race/ethnicity, No. (%)b | ||
| White | 138 (50.9) | 136 (50.4) |
| African American | 115 (42.4) | 110 (40.7) |
| All other, No. (%) | 32 (11.8) | 36 (13.3) |
| Hispanic, Spanish, or Latino, No. (%) | 43 (15.9) | 47 (17.4) |
| Never married, No. (%) | 68 (25.1) | 67 (24.8) |
| Married, No. (%) | 89 (32.8) | 84 (31.1) |
| Divorced, No. (%) | 82 (30.3) | 79 (29.3) |
| Educational level, No. (%) | ||
| Less than college | 54 (19.9) | 43 (15.9) |
| College credit/degree | 201 (74.2) | 210 (77.8) |
| Graduate credit/degree | 16 (5.9) | 17 (6.3) |
| Length of current unemployment, mean (SD), y | 2.7 (3.5) | 2.9 (4.1) |
| Length of current unemployment, median (IQR), wk | 73.7 (164.7) | 78.0 (156.0) |
| Duration of longest job in lifetime, mean (SD), y | 8.3 (5.8) | 8.7 (6.4) |
| Current major depressive episode, No. (%) | 87 (32.1) | 83 (30.7) |
| Past major depressive episode, No. (%) | 183 (67.5) | 173 (64.1) |
| Current agoraphobia, No. (%) | 64 (23.6) | 59 (21.9) |
| Current panic disorder, No. (%) | 37 (13.7) | 33 (12.2) |
| Social anxiety disorder (generalized), No. (%) | 35 (12.9) | 28 (10.4) |
| Alcohol use disorder, past 12 mo, No. (%) | 54 (19.9) | 78 (28.9) |
| Non-alcohol use disorder, past 12 mo, No. (%) | 47 (17.3) | 40 (14.8) |
| Duration of PTSD, mean (SD), y | 13.3 (11.6) | 13.4 (11.3) |
| Total CAPS-IV lifetime, mean (SD)c | 84.1 (18.9) | 84.8 (18.3) |
| PCL-5, mean (SD)d | 46.2 (15.8) | 45.1 (17.0) |
| PCL-5 positive for current PTSD (≥33), No. (%) | 209 (77.1) | 204 (75.6) |
| PCL-5 very mild (0-18), No. (%) | 14 (5.2) | 20 (7.4) |
| PCL-5 mild (19-37), No. (%) | 64 (23.6) | 60 (22.2) |
| PCL-5 moderate (38-59), No. (%) | 128 (47.2) | 138 (51.1) |
| PCL-5 severe (60-80), No. (%) | 63 (23.2) | 49 (18.1) |
| Serious or Reportable AEs, No. (%) | ||
| Participants with SAEs | 63 (23.2) | 64 (23.7) |
| No. of SAEs | 129 | 94 |
| Participants with AEs | 36 (13.3) | 40 (14.8) |
| No. of reportable AEs | 52 | 51 |
| AEs attributed to PTSD (yes/possibly), No. (% of events) | 50 (38.8) | 28 (29.8) |
| AEs possibly attributed to occupation (yes/possibly), No. (% of events) | 5 (3.9) | 3 (3.2) |
| AEs attributed to study intervention, No. (% of events) | 3 (2.3) | 2 (2.1) |
| Discontinuation from study due to SAE, No. (% of events) | 3 (2.3) | 4 (4.3) |
| Deaths, No. (% of participants) | 3 (1.1) | 2 (0.7) |
Abbreviations: AE, adverse event; CAPS-IV, Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale for DSM-IV for lifetime; IPS, individual placement and support; IQR, interquartile range; PCL-5, PTSD Checklist for DSM-5 for the previous month; PTSD, posttraumatic stress disorder; SAE, serious AE.
a
Denominators vary for some factors due to missing data.
b
Participants were permitted to indicate more than 1 race.
c
Possible range, 0 to 136 (higher score is worse).
d
Very mild, 0 to 18; mild, 19 to 37; moderate, 38 to 59; and severe, 60 to 80.