Reduction of Depression in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching
Starting soon · Not applicable · Has a placebo group
Conditions studied: Hearing Disability, Depression, Mobility Disability
In brief
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.
Key facts
- Study ID
- NCT07195292
- Run by
- Toivoa Inc
- People needed
- 200
- Starts
- 2026-08-01
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 technology-based intervention (e.g., Android phone, iPhone, iPad, internet access)
- Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days prior to study entry)
- Able to read and speak English fluently
- Resident of the United States and living in the United States for the duration of the trial
You may not qualify if…
- 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).
- Currently pregnant, breastfeeding, or planning to become pregnant during the treatment period
Where it is running
- Delaware State University — Dover, Delaware, United States
- New Jersey Department of Veterans Health — East Orange, New Jersey, United States
- Louis Stokes Cleveland VAMC — Cleveland, Ohio, United States
- South Texas Veterans Health Care System — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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