NCT06477913

Exploratory Study for Toivoa-001 on Human Factors

Exploratory Study for Reduction of Anxiety and Depression Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy and National Board Health and Wellness Coaches (NBHWC) For People With Disabilities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Toivoa Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Investigators propose a single-arm controlled trial evaluating (Rauha) plus usual care as an intervention for persons actively seeking treatment for anxiety and/or depression. Recruitment will occur at a single US health facility where approximately 30 adults with disabilities and clinically elevated anxiety and/or depressive symptoms will be we will recruited and enrolled. Eligible participants will be administered Rauha as a remote app with site oversight. Patients will be monitored and encouraged by Mental Health Coaches to complete the therapy. Mental Health Coaches will also provide instruction on completion of modules. Patients will engage with the Rauha app, have the opportunity to complete all 33 modules, receive Mental Health Coach support, and engage with the online community for a total of 8 weeks. The community forum feature will provide patients access to a community forum that understands the specific struggles of the condition, allowing users to interact with one another via an online community designed for empowerment and support. Support from a Mental Health Coach will be provided at prescribed intervals and will also be available to each participant in addition to access to the online community. A participant is considered to have completed the study if he or she has completed all assessments. The end of the study is defined as completion of the 4 week follow-up assessment

Conditions

• Anxiety Depression
• Disability Physical

Interventions

Type	Name	Description
DEVICE	Rauha	A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Mental Health Coaches

Timeline

• Start date: 2024-07-11
• Primary completion: 2024-12-27
• Completion: 2025-01-09
• First posted: 2024-06-27
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study