Trial Outcomes & Findings for Exploratory Study for Toivoa-001 on Human Factors (NCT NCT06477913)

Participants were recruited through approved study flyers at Endeavors Programs in San Antonio, Texas, as well as through other approved recruitment channels, including clinical and community referrals.

No one enrolled in the study dropped from participating prior to initiating (and completing) the intervention.

Exploratory Study for Toivoa-001 on Human Factors

Assess the proportion of the Intent to Treat population who remain active users of the program at the end of the 8-week primary study period. Completion rates will be reported as the percentage of enrolled users who continue to engage with the digital therapy per week.

The Hamilton Anxiety Rating Scale (HAM-A) is a structured interview assessing anxiety symptoms using 14 items, each rated from 0 ("not present") to 4 ("severe"). Scores range from 0 to 56 with higher scores indicating more severe anxiety. Changes in HAM-A scores will be measured between two timepoints at Baseline and 8 weeks.

The Hamilton Depression Rating Scale (HAM-D) is a structured interview assessing depression based on 17 items; items range from 0 ("not present") to 4 ("severe") and 0 ("absent") to 2 ("severe"). Total scores range 0 to 54 with higher scores indicating more severe depression. Changes in HAM-D scores will be measured between two timepoints at Baseline and 8 weeks.

The Hamilton Anxiety Rating Scale (HAM-A) is a structured interview assessing anxiety symptoms using 14 items, each rated from 0 ("not present") to 4 ("severe"). Scores range from 0 to 56 with higher scores indicating more severe anxiety. Changes in HAM-A scores will be measured between two timepoints at Baseline and 12 weeks.

The Hamilton Depression Rating Scale (HAM-D) is a structured interview assessing depression based on 17 items; items range from 0 ("not present") to 4 ("severe") and 0 ("absent") to 2 ("severe"). Total scores range 0 to 54 with higher scores indicating more severe depression. Changes in HAM-D scores will be measured between two timepoints at Baseline and 12 weeks.

An opinion survey of the features built into Rauha as assessed by users who have fully completed the digital therapy program over a period of 8 weeks. The survey consists numeric responses ranging from 1 (low) to 5 (high) and is for information purposes only. Lower ratings correspond to greater favorability.

An opinion survey on the perceived value provided by Rauha as assessed by users who have fully completed the digital therapy program over a period of 8 weeks. The survey consists numeric responses ranging from 1 (low) to 5 (high) and is for information purposes only. Lower ratings correspond to greater favorability.

An opinion survey on the ease of use of Rauha as assessed by users who have fully completed the digital therapy program over a period of 8 weeks. The survey consists numeric responses ranging from 1 (low) to 5 (high) and is for information purposes only. Lower ratings correspond to greater favorability.