Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching - A Randomized Clinical Trial

The purpose of this study is to see if a mobile-delivered mental health program called Toivoa-001, which combines digital cognitive behavioral therapy (CBT) with personal mental health coaching, can effectively reduce anxiety in adults with hearing or mobility disabilities. The study aims to answer whether this dual-intervention digital service is more effective at lowering anxiety symptoms over an 8-week period than a "sham" digital program that is developed to look similar but does not contain active therapeutic content. The investigators hypothesize that participants who use the Toivoa-001 program will show significantly greater reductions in anxiety compared to those using the sham program, and that these mental health benefits will last through a 12-week follow-up. Adults within the disability community frequently encounter unique environmental and societal barriers - such as limited physical accessibility, transportation challenges, and workplace inflexibility - that can directly drive or worsen anxiety. By offering a fully remote and accessible mobile tool, this study seeks to determine if a digital health service can deliver scalable, effective anxiety relief tailored to the lived experiences of people with disabilities.

NCT Number	NCT07140497
Lead Sponsor	Toivoa Inc Collaborators: Delaware State University, VA New Jersey Health Care System, South Texas Veterans Health Care System, Louis Stokes VA Medical Center
Conditions	Hearing Disability, Anxiety, Mobility Disability
Enrollment	200 participants
Start Date	2026-08
Primary Completion	2027-08 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-20