Toivoa Inc
The purpose of this study is to see if a mobile-delivered mental health program called Toivoa-002, which combines digital cognitive behavioral therapy (CBT) with personal coaching, can effectively reduce depression in adults with hearing or mobility disabilities. The study aims to answer whether this dual-intervention digital service is more effective at lowering depression 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-002 program will show significantly greater reductions in depression 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 depression. By offering a fully remote and accessible mobile tool, this study seeks to determine if a digital health service can deliver scalable, effective depression relief tailored to the lived experiences of people with disabilities.
This pivotal, two-arm randomized clinical trial (RCT) will assess the efficacy of Toivoa-002, a mobile-delivered cognitive behavioral therapy (CBT) program tailored for people with disabilities, combined with National Board for Health and Wellness Coaching (NBHWC)-certified coaching, in reducing depression symptoms compared to a sham digital program. Recruitment will focus on adults with hearing or mobility disabilities, chosen to represent the broader U.S. disability community due to shared barriers to social participation, high prevalence of depression, and common co-morbidities. Depression…
Inclusion Criteria: * Provision of signed and dated informed consent form * Presence of self-reported hearing or mobility disability * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study * Male or female, age 22 years or older * A score of 17 or higher on the HAM-D * Clinical diagnosis of depression based on DSM-5 diagnostic criteria * Willingness to adhere to the Toivoa-002 or sham regimen once per week, including scheduling and weekly meetings with coaches * Access to necessary resources for participating in a te…
General health and wellness information with interactive quizzes. This content is not related to depression treatment or CBT techniques.
A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Coaches