Table 3.

Primary outcome: change in distress between baseline and follow-up (12 weeks)^a.

			Interventionb					Controlc					Analysis of covariance
			Values, n		Values, mean (SD)		Values, n			Values, mean (SD)		F test (df)			P value		ηp²
Intention-to-treat
	Baseline	99		6.0 (2.1)		119			6.0 (2.4)		N/Ad			N/A		N/A
	Follow-up	99		5.1 (2.5)		119			5.9 (2.5)		N/A			N/A		N/A
	Change	99		–0.8 (2.8)		119			–0.1 (2.9)		4.7 (1, 215)			.03		0.02
Per-protocol
	Baseline	50		6.0 (2.2)		74			5.7 (2.2)		N/A			N/A		N/A
	Follow-up	50		4.8 (2.8)		74			5.9 (2.4)		N/A			N/A		N/A
	Change	50		–1.2 (3.2)		74			0.2 (2.8)		6.9 (1, 121)			.01		0.05

^aAn analysis of covariance was used to test for differences in change in distress levels between groups from baseline to follow-up (12 weeks), controlling for baseline. The partial eta–squared is the reported standardized effect size for the mean difference. The effect sizes can be interpreted as small, medium, or large at ≥0.01, ≥0.06, and ≥0.14, respectively. The results of the intention-to-treat and per-protocol analysis are reported.

^bIntervention=12-week access to digital therapeutic app intervention+usual care.

^cControl=usual care.

^dN/A: not applicable.