← Back to all trials
Not Yet Recruiting
NCT07195292
Reduction of Depression in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching
Conditions: Hearing Disability, Depression, Mobility Disability
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Toivoa Inc
Location: Delaware State University Dover Delaware
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.
Eligibility Criteria
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 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07195292). StuddyBuddy aggregates publicly available trial information.