About this trial
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 mental health 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Medical diagnosis of psychotic disorder or bipolar disorder
Participation in another treatment trial at the time of study
Substance use disorder in the past 12 months (excluding tobacco)
Suicide attempt in the past year or elevated suicide risk other than passive ideation (i.e., endorsing items reflecting intent, identifying means, suicide planning, or suicide-related preparations).
Trial design
Treatments tested in this trial
- Sham Digital Program - General health education and interactive quizzes unrelated to depression or CBT.
- Toivoa-002 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.
Treatment groups
Sponsors and collaborators
Toivoa Inc
Lead sponsor
Delaware Health Empowerment
Collaborator
DelCare Health Solutions
Collaborator
Delaware State University
Collaborator