Table 3.
Multilevel Modeling Results for Primary and Secondary Outcomes
| Treatment Effect at Baseline | Treatment Effect on Change from Pre to Post | Treatment Effect on Change from Pre to FU6 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Coef. | SE | p | Coef. | SE | p | Coef. | SE | p | |
| Primary Outcomes | |||||||||
| SDS | −2.18 | 1.34 | 0.10 | −3.18 | 1.42 | 0.025 | −1.52 | 1.40 | 0.28 |
| DSM5 Cross-Cutting Measure | −0.25 | 1.89 | 0.89 | −5.88 | 1.81 | 0.001 | −3.90 | 1.79 | 0.03 |
| PROMIS-SD | −0.85 | 1.33 | 0.52 | −5.55 | 1.31 | <0.0001 | −4.92 | 1.30 | <0.0001 |
| PROMIS-SRI | −2.92 | 2.49 | 0.24 | −9.14 | 2.44 | <0.0001 | −5.37 | 2.42 | 0.027 |
| Secondary Outcomes | |||||||||
| QIDS | −0.62 | 0.92 | 0.50 | −0.95 | 0.95 | 0.32 | −1.67 | 0.94 | 0.08 |
| ASSIST | 0.26 | 0.24 | 0.26 | −0.09 | 0.24 | 0.72 | −0.08 | 0.23 | 0.74 |
| PSYRATS | 0.87 | 5.84 | 0.88 | −2.46 | 7.08 | 0.73 | −17.52 | 7.54 | 0.02 |
| WHODAS | −4.87 | 4.42 | 0.27 | −7.19 | 4.18 | 0.09 | −1.13 | 4.16 | 0.79 |
| CDC Healthy Days: Overall Health | −0.12 | 0.20 | 0.55 | 0.16 | 0.21 | 0.46 | −0.34 | 0.21 | 0.10 |
| Sleep Diary | |||||||||
| SE mean (min) | −0.46 | 2.35 | 0.85 | 5.68 | 2.67 | 0.03 | 5.89 | 2.64 | 0.03 |
| SE variability (min) | −0.33 | 1.45 | 0.82 | −1.45 | 1.86 | 0.43 | −1.55 | 1.84 | 0.40 |
| TST mean (min) | −24.98 | 19.33 | 0.20 | 24.85 | 20.60 | 0.23 | 34.31 | 20.36 | 0.09 |
| TST variability (min) | −3.08 | 12.89 | 0.81 | −19.90 | 15.23 | 0.19 | −1.76 | 15.07 | 0.91 |
| TWT mean (min) | −6.18 | 15.62 | 0.69 | −39.33 | 18.83 | 0.04 | −28.56 | 18.64 | 0.13 |
| TWT variability (min) | −2.20 | 11.18 | 0.84 | −17.57 | 14.11 | 0.21 | −16.05 | 13.97 | 0.25 |
| BT mean | 0.06 | 0.36 | 0.87 | −0.55 | 0.34 | 0.10 | −0.71 | 0.34 | 0.04 |
| BT variability | −0.08 | 0.19 | 0.68 | −0.31 | 0.25 | 0.20 | −0.45 | 0.25 | 0.07 |
| WT mean | −0.57 | 0.35 | 0.11 | −0.33 | 0.38 | 0.39 | −0.02 | 0.38 | 0.96 |
| WT variability | −0.10 | 0.18 | 0.59 | −0.39 | 0.20 | 0.047 | 0.20 | 0.20 | 0.30 |
| Actigraphy | |||||||||
| TST mean (min) | 36.92 | 23.14 | 0.11 | −12.68 | 23.42 | 0.59 | −28.33 | 23.30 | 0.22 |
| TST variability (min) | 0.15 | 15.44 | 0.99 | 4.65 | 18.72 | 0.80 | −7.57 | 18.63 | 0.68 |
| TWT mean (min) | 4.16 | 8.48 | 0.62 | −4.42 | 10.14 | 0.66 | −13.34 | 10.09 | 0.19 |
| TWT variability (min) | −0.005 | 0.13 | 0.97 | −0.05 | 0.17 | 0.77 | −0.22 | 0.17 | 0.20 |
| Waking activity count mean | −41.19 | 107.66 | 0.70 | −76.85 | 80.83 | 0.34 | −87.15 | 79.93 | 0.28 |
| Waking activity count variability | 0.01 | 0.10 | 0.95 | −0.15 | 0.11 | 0.18 | −0.27 | 0.11 | 0.02 |
| Sleep health composite | 0.26 | 0.26 | 0.32 | 0.91 | 0.30 | 0.002 | 0.64 | 0.30 | 0.03 |
Note. SDS = Sheehan Disability Scale. DSM 5 DSM-5 Cross-Cutting Measure. PROMIS-SD = Patient-Reported Outcomes Measurement Information System–Sleep Disturbance. PROMIS-SRI = Patient-Reported Outcomes Measurement Information System– Sleep-Related Impairment. QIDS = Quick Inventory of Depressive Symptoms. ASSIST = Alcohol, Smoking and Substance Involvement Screening Test. PSYRATS = Psychotic Symptoms Rating Scales. WHODAS = World Health Organization Disability Assessment Schedule 2.0. CDC Healthy Days: overall health question from the 4-question healthy days core module developed by the Centers for Disease Control and Prevention. SE = sleep efficiency (total sleep time/time in bed × 100). TST = total sleep time. TWT = total wake time. BT = bedtime, WT = wake time. All the p-values in bold are the exact p-values and remained significant after applying the Benjamini-Hochberg procedure with a 5% false discovery rate assumed.