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Mobility Disability / Hearing Disability / Depression · Interventional Study
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record for a planned, not-yet-recruiting sham-controlled study of a combined digital CBT and coaching intervention (Toivoa-002) for depression in adults with hearing or mobility disabilities. No results have been posted; the record describes the study hypothesis and design only.
Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Hearing Disability, Depression, Mobility Disability; age from 22 Years. Intervention: Toivoa-002 Digital CBT + NBHWC Coaching. Compared with: General Health Education + Interactive Quizzes — Sham Comparator. n = 200. 4 sites: United States.
This is a clinical trial registry record for a planned, not-yet-recruiting sham-controlled study of a combined digital CBT and coaching intervention (Toivoa-002) for depression in adults with hearing or mobility disabilities. No results have been posted; the record describes the study hypothesis and design only.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a planned interventional study with no results posted; it describes the design and hypothesis only, making it a preliminary registry record awaiting enrollment and outcome data.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07195292). This is a study registration, not published results. Lead sponsor: Toivoa Inc. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Hearing Disability, Depression, Mobility Disability. Interventions: DEVICE: Sham Digital Program - General health education and interactive quizzes unrelated to depression or CBT.; DEVICE: Toivoa-002 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.. Primary outcome measures: Change in Hamilton Depression Rating Scale (HAM-D) from Baseline to Week 8 , From Baseline to end of treatment (8 weeks). Brief summary: 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.
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