Table 3.
Depression-Specific Outcomes in the 309 Participants Enrolled in the INCPAD Trial for Depression
| Clinical Outcome | Intervention (154)a | Usual Care (155)a | Time-Specific Between-Group Difference or Relative Risk (95% CI) | Overall P value by MMRMb |
|---|---|---|---|---|
| Primary depression outcome (n = assessed cases) | ||||
| HSCL-20 depression severity, mean (SD) (range, 0–4) | <.0001 | |||
| Baseline (n = 309) | 1.64 (0.63) | 1.64 (0.65) | 0.00 (−0.15 to 0.14) | |
| 3-mo follow-up (n = 246) | 1.08 (0.61) | 1.35 (0.73) | −0.27 (−0.44 to −0.10) | |
| 6-mo follow-up (n = 223) | 1.01 (0.59) | 1.31 (0.73) | −0.29 (−0.47 to −0.12) | |
| 12-mo follow-up (n = 202) | 1.06 (0.65) | 1.32 (0.83) | −0.26 (−0.46 to −0.05) | |
| HSCL-20 depression severity responder, N (%) c | <.001 | |||
| 3-mo follow-up (n = 246) | 45 (36.3) | 25 (20.5) | 1.77 (1.16 to 2.70) | |
| 6-mo follow-up (n = 223) | 42 (38.2) | 27 (23.9) | 1.60 (1.06 to 2.40) | |
| 12-mo follow-up (n = 202) | 33 (33.7) | 29 (27.9) | 1.21 (0.80 to 1.83) | |
| Secondary depression outcomes (n = assessed cases) | ||||
| Major depressive disorder, N (%) | .002 | |||
| Baseline (n = 309) | 94 (61.0) | 96 (61.9) | 0.99 (0.83 to 1.18) | |
| 3-mo follow-up (n = 247) | 30 (24.2) | 47 (38.2) | 0.63 (0.43 to 0.93) | |
| 12-mo follow-up (n = 203) | 21 (21.4) | 37 (35.2) | 0.61 (0.38 to 0.96) | |
| Mental Health Inventory depression severity subscale, mean (SD), range (3–15) | .009 | |||
| Baseline (n = 309) | 8.61 (2.82) | 8.99 (2.59) | −0.38 (−0.98 to 0.23) | |
| 12-mo follow-up (n = 202) | 7.01 (2.58) | 7.91 (3.00) | −0.90 (−1.68 to −0.12) | |
a
The number of depressed subjects who were assessed for depression outcomes was 246–247 (124 intervention and 122–123 controls) at 3 months, 223 (110 intervention and 113 controls) at 6 months, and 202–203 (98 intervention and 104–105 controls) at 12 months.
b
Mixed effects model repeated measures (MMRM) analysis was used to compare group differences over 12 months, adjusting for time effect and for baseline value of outcome variable. Assessments were conducted at baseline, 1, 3, 6 and 12 months for HSCL-20 and at baseline, 3 and 12 months for secondary depression outcomes.
c
Defined as 50% or greater decrease in HSCL-20 from baseline