Table 2.
Summary statistics and results from mixed model analysis of primary and secondary outcomes
| Primary and secondary outcomes | Visit | Descriptive statistics |
Mixed model analysis |
|||
|---|---|---|---|---|---|---|
| intervention (n = 120) estimated mean (95% CI) |
EUC (n = 120) estimated mean (95% CI) |
difference in LS mean (95%CI) |
p value | effect sizea (95% CI) | ||
| HADS-Depression | Baseline 7-week 2-month 6-month |
9.7 (9.0 to 10.3) 7.4 (6.7 to 8.1) 7.1 (6.3 to 7.9) 6.4 (5.6 to 7.2) |
9.4 (8.8 to 10.1) 8.3 (7.5 to 9.1) 8.4 (7.6 to 9.3) 7.5 (6.6 to 8.4) |
1.1 (0.1 to 2.2) 1.6 (0.4 to 2.8) 1.3 (0.8 to 2.6) |
0.03 0.009 0.04 |
0.3 (0.0 to 0.6) 0.4 (0.1 to 0.7) 0.4 (0.2 to 0.7) |
| HADS-Anxiety | Baseline 7-week 2-month 6-month |
12.6 (11.9 to 13.3) 9.4 (8.6 to 10.3) 9.1 (8.3 to 9.9) 9.2 (8.4 to 10.0) |
12.8 (12.1 to 13.5) 11.0 (10.1 to 11.8) 10.8 (10.0 to 11.7) 11.0 (10.1 to 11.8) |
1.4 (0.3 to 2.4) 1.4 (0.3 to 2.6) 1.5 (0.4 to 2.7) |
0.009 0.01 0.01 |
0.4 (0.1 to 0.6) 0.4 (0.1 to 0.7) 0.4 (0.1 to 0.7) |
| GAD-7 | Baseline 7-week 2-month 6-month |
11.4 (10.5 to 12.2) 6.8 (5.9 to 7.7) 6.8 (5.9 to 7.7) 7.3 (6.4 to 8.2) |
12.1 (11.2 to 12.9) 10.0 (9.1 to 11.0) 9.1 (8.1 to 10.0) 8.6 (7.5 to 9.6) |
2.6 (1.4 to 3.7) 1.6 (0.2 to 2.9) 0.5 (−.9 to 2.0) |
0.001 0.02 0.46 |
0.5 (0.3 to 0.8) 0.3 (0.0 to 0.7) 0.1 (−0.2 to 0.4) |
| Sleep Impairment Index | Baseline 7-week 2-month 6-month |
8.6 (7.8 to 9.4) 6.7 (5.9 to 7.5) 6.5 (5.6 to 7.3) 6.6 (5.8 to 7.4) |
9.0 (8.2 to 9.8) 8.0 (7. to 8.8) 7.5 (6.7 to 8.4) 7.6 (6.7 to 8.5) |
0.9 (−0.1 to 1.9) 0.7 (−0.4 to 1.8) 0.6 (−0.6 to 1.8) |
0.07 0.20 0.31 |
0.2 (−0.0 to 0.5) 0.2 (−0.1 to 0.4) 0.2 (−0.1 to 0.4) |
| PANAS-positive | Baseline 7-week 2-month 6-month |
20.2 (18.9 to 21.5) 23.7 (22.3 to 25.0) 24.2 (22.8 to 25.6) 24.2 (22.8 to 25.6) |
20.6 (19.3 to 22.0) 21.4 (19.9 to 22.9) 20.5 (19.0 to 22.0) 20.9 (19.3 to 22.5) |
−2.7 (−4.7 to −0.7) −4.1 (−6.4 to 1.9) −2.7 (−4.6 to −0.7) |
0.008 0.001 0.008 |
−0.4 (−0.7 to −0.1) −0.6 (−1.0 to 0.3) −0.4 (−0.7 to −0.1) |
| PANAS-negative | Baseline 7-week 2-month 6-month |
23.6 (22.2 to 25.0) 17.1 (15.7 to 18.5) 17.2 (16.1 to 19.1) 17.6 (16.1 to 19.1) |
23.8 (22.4 to 25.2) 21.5 (19.9 to 23.0) 20.2 (18.6 to 21.8) 20.4 (18.7 to 22.0) |
4.1 (2.1 to 6.2) 2.7 (0.5 to 5.0) 2.5 (−3.6 to 0.7) |
0.001 0.02 0.03 |
0.5 (0.3 to 0.8) 0.3 (0.1 to 0.6) 0.3 (−0.4 to 0.1) |
| Anhedonia | Baseline 7-week 2-month 6-month |
126.4 (122.2 to 128.7) 133.0 (128.7 to 137.2) 133.1 (128.8 to 137.5) 129.3 (125.0 to 133.7) |
124.50 (120.3 to 128.7) 124.8 (120.3 to 129.3) 122.2 (117.6 to 126.8) 121.4 (116.7 to 126.2) |
−6.3 (−11.5 to − 1.0) − 9.0 (−14.7 to − 3.4) − 6.0 (−11.8 to − 0.2) |
0.02 0.002 0.04 |
−0.3 (−0.5 to 0.0) − 0.4 (−0.7 to − 0.2) − 0.3 (−0.6 to 0.0) |
| CSS: Danger | Baseline 7-week 2-month 6-month |
11.9 (10.8 to 13.1) 9.4 (8.3 to 10.6) 6.8 (5.6 to 7.9) 5.7 (4.5 to 6.9) |
10.8 (9.6 to 11.9) 9.9 (8.7 to 11.1) 7.4 (6.2 to 8.7) 7.1 (5.8 to 8.4) |
1.6 (0.1 to 3.1) 1.8 (0.2 to 3.5) 2.5 (0.8 to 4.3) |
0.03 0.03 0.004 |
0.2 (0.0 to 0.5) 0.3 (0.0 to 0.5) 0.4 (0.1 to 0.6) |
| CSS: Economic Fears | Baseline 7-week 2-month 6-month |
4.0 (3.3 to 4.8) 2.8 (2.0 to 3.5) 1.6 (0.8 to 2.4) 1.3 (0.5 to 2.1) |
4.1 (3.4 to 4.8) 3.3 (2.5 to 4.1) 2.0 (1.2 to 2.9) 2.0 (1.2 to 2.9) |
0.5 (−0.5 to 1.4) 0.4 (−0.8 to 1.6) 0.7 (−0.6 to 2.0) |
0.33 0.50 0.28 |
0.1 (−0.1 to 0.3) 0.1 (−0.2 to 0.3) 0.2 (−0.1 to 0.4) |
| CSS: Xenophobia | Baseline 7-week 2-month 6-month |
2.9 (2.1 to 3.7) 2.1 (1.3 to 2.9) 1.4 (0.5 to 2.2) 1.8 (1.0 to 2.6) |
2.7 (1.9 to 3.5) 2.5 (1.7 to 3.4) 2.7 (1.78 to 3.6) 2.2 (1.3 to 3.2) |
0.7 (−0.4 to 1.7) 1.5 (0.3 to 2.8) 0.7 (−.6 to 2.0) |
0.23 0.01 0.32 |
0.1 (−0.1 to 0.3) 0.3 (0.1 to 0.6) 0.1 (−0.1 to 0.4) |
| CSS: Traumatic Stress | Baseline 7-week 2-month 6-month |
7.5 (6.6 to 8.4) 5.1 (4.2 to 6.0) 3.2 (2.3 to 4.2) 2.4 (1.5 to 3.3) |
6.8 (5.9 to 7.7) 5.4 (4.5 to 6.4) 3.7 (2.7 to 4.7) 3.0 (1.9 to 4.0) |
1.0 (−0.1 to 2.2) 1.1 (−0.2 to 2.5) 1.3 (−.2 to 2.7) |
0.07 0.10 0.08 |
0.2 (0.0 to 0.4) 0.2 (0.0 to 0.5) 0.2 (0.0 to 0.5) |
| CSS: Contamination Fears | Baseline 7-week 2-month 6-month |
11.0 (9.9 12.1) 8.6 (7.5 to 9.7) 6.2 (5.1 to 7.3) 5.2 (4.0 to 6.3) |
9.5 (8.4 to 10.6) 9.1 (7.9 to 10.2) 6.9 (5.7 to 8.1) 5.8 (4.6 to 7.1) |
1.9 (0.6 to 3.2) 2.2 (0.7 to 3.6) 2.1 (0.6 to 3.7) |
0.003 0.004 0.007 |
0.3 (0.1 to 0.5) 0.3 (0.1 to 0.6) 0.1 (−0.1 to 0.6) |
| CSS: Checking | Baseline 7-week 2-month 6-month |
8.4 (7.7 to 9.0) 5.5 (4.8 to 6.2) 4.5 (3.8 to 5.3) 3.6 (2.9 to 4.4) |
7.5 (6.8 to 8.2) 6.1 (5.3 to 6.8) 4.1 (3.3 to 4.9) 4.2 (3.4 to 5.0) |
1.4 (0.4 to 2.4) 0.4 (−0.7 to 1.6) 1.4 (0.2 to 2.7) |
0.006 0.5 0.02 |
0.3 (0.1 to 0.5) 0.1 (−0.2 to 0.4) 0.3 (0.0 to 0.6) |
EUC, enhanced usual care; LS, least square; HADS, Hospital Anxiety and Depression Scale (depression subscale score range: 0–21; anxiety subscale score range: 0–21; higher scores indicate elevated anxiety or depression); GAD-7 (total score range: 0–21; higher scores indicate more severe worry); SII, Sleep Impairment Index (total score range: 0–20; higher scores indicate more severe sleep impairment); PANAS, Positive and Negative Affect Schedule (subscale total score range: 10–50 on positive and negative scales, respectively; higher scores indicate more greater positive and negative mood, respectively); Pleasure Scale (total score range: 36–180; lower scores indicate more severe anhedonia); CSS, COVID-19 Stress Scale (each scale total score range: 0–24; higher scores indicate more severe stress). Effect size was calculated by the difference in least square means between intervention and EUC from mixed model divided by the pooled standard deviation.