Exploratory Study for Toivoa-001 on Human Factors
NCT Number: NCT06477913
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety Depression|Disability Physical
Interventions: DEVICE: Rauha
Sponsor: Toivoa Inc
Collaborators: Family Endeavors, Inc DBA Endeavors|Advarra, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06
Completion Date: 2024-12
Locations: The Steven A. Cohen Military Family Clinic at Endeavors, San Antonio, Texas, 78249, United States

Summary:
The Study will evaluate Rauha as an experimental digital therapeutic for persons with Disabilities suffering from anxiety and/or depression. The study will evaluate completion rates of the program and survey the user's experience upon completion. Changes in anxiety and depression scores will be monitored during the study.

Primary Outcome Measures: Therapy dropout rates as a percentage of enrolled participants, 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. Dropout rates will be reported as the percentage of enrolled users who continue to engage with the digital therapy per week., 8 weeks
Secondary Outcome Measures: Changes in numeric GAD-7 Assessment scores following therapy., Changes from baseline anxiety scores based on GAD-7 for users with disabilities after using Rauha for a period of 8 weeks. Assessments will be clinician administered., 8 weeks|Changes in numeric PHQ-9 Assessment scores following therapy., Changes from baseline depression scores on PHQ-9 for users with disabilities after using Rauha for a period of 8 weeks. Assessments will be clinician administered., 8 weeks|Changes of numeric GAD-7 Assessment scores from completion through 4-weeks post therapy., Comparison of anxiety scores based on GAD-7 for users with disabilities after completing Rauha vs GAD-7 scores 4 weeks post completion. Assessments will be clinician administered., 12 weeks|Changes of numeric PHQ-9 Assessment scores from completion through 4-weeks post therapy., Comparison of depression scores based PHQ-9, respectively, for users with disabilities after completing Rauha vs PHQ-9 scores 4 weeks post completion. Assessments will be clinician administered., 12 weeks
Other Outcome Measures: User Experience Survey, 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., 8 weeks|User Acceptability Survey, 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., 8 weeks|System Usability Survey, 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., 8 weeks