Table 4.

Results for Primary and Secondary Outcomes of the eIMPACT Trial: Intention-to-Treat Analyses using Multiple Imputation Adjusted for Age Group and Sex

	All (N = 216) M (SD)	Intervention (n = 107) M (SD)	Usual Care (n = 109) M (SD)	p value
Brachial Flow-Mediated Dilation (% dilation)
Pre-Treatment FMD	2.72 (2.31)	2.59 (2.16)	2.85(2.45)	0.42
Post-Treatment FMDa	---	2.28 (2.04)	2.44 (2.29)	0.60
Pre-to-Post Change in FMDb	---	−0.30 (2.25)	−0.41 (2.90)	0.78
Depressive Symptoms (possible range of SCL-20: 0.00–4.00)
Pre-Treatment SCL-20	1.91 (0.72)	1.86 (0.76)	1.96 (0.68)	0.30
Post-Treatment SCL-20c	---	1.12 (0.80)	1.65 (0.83)	< 0.01
Pre-to-Post Change in SCL-20b	---	−0.75 (0.78)	−0.31 (0.66)	< 0.01
High-Frequency Heart Rate Variability (ln of ms2/Hz)
Pre-TreatmentHF HRV	5.22 (1.71)	5.29 (1.72)	5.15 (1.66)	0.49
Post-Treatment HF HRVc	---	5.39 (1.85)	5.35 (1.78)	0.81
Pre-to-Post Change in HF HRVb	---	0.10 (1.73)	0.20 (1.66)	0.68
Interleukin-6 (log10 of pg/mL)
Pre-Treatment IL-6	0.73 (0.27)	0.71 (0.28)	0.75 (0.27)	0.22
Post-Treatment IL-6c	---	0.73 (0.26)	0.77 (0.27)	0.20
Pre-to-Post Change in IL-6b	---	0.02 (0.16)	0.02 (0.21)	1.00
High-Sensitivity C-Reactive Protein (log10 of mg/L)
Pre-Treatment hsCRP	0.69 (0.40)	0.67 (0.40)	0.71 (0.40)	0.38
Post-Treatment hsCRPc	---	0.65 (0.40)	0.74 (0.41)	0.09
Pre-to-Post Change in hsCRPb	---	−0.02 (0.29)	0.03 (0.30)	0.27
β-thromboglobulin (ng/mL)
Pre-Treatment BTG	204(113)	194 (118)	213 (108)	0.22
Post-Treatment BTGc	---	185 (125)	205 (118)	0.23
Pre-to-Post Change in BTGb	---	−9 (135)	−8 (123)	0.94
Platelet Factor 4 (ng/mL)
Pre-Treatment PF4	4165 (2094)	4038 (2047)	4290 (2133)	0.37
Post-Treatment PF4c	---	3842 (2011)	4351 (2341)	0.09
Pre-to-Post Change in PF4b	---	−196 (2230)	61 (2373)	0.43

Note. Values are from imputed datasets. Post-treatment and pre-to-post change values are not shown for all participants (both groups combined), as it is differential change between groups that is of interest. Pre-treatment values for all participants are shown to further characterize the sample. Observed ns for each outcome were (pre-treatment; post-treatment; pre-to-post change): FMD (212, 195, 194), SCL-20 (214, 200, 198), HF HRV (204, 190, 179), IL-6 (214, 195, 194), hsCRP (214, 196, 195), BTG (214, 195, 194), and PF4 (214, 195, 194). P values are from analysis of covariance (ANCOVA) models using multiple imputation and adjusting for the stratification variables of age group and sex. FMD = flow-mediated dilation; SCL-20 = Hopkins Symptom Checklist-20; HF HRV = high-frequency heart rate variability; IL-6 = interleukin-6; hsCRP = high-sensitivity C-reactive protein; BTG = β-thromboglobulin; PF4 = platelet factor 4.

^aPrimary outcome

^bPre-to-post change values were computed as: post-treatment value - pre-treatment value.

^cSecondary outcomes