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Reduction of Depression in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching

NCT07195292

Not Yet RecruitingNA

Sponsor: Toivoa Inc

Conditions: Hearing Disability, Depression, Mobility Disability

Interventions: 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.

Countries: United States

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 overview

Sex: ALL

Age: 22 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (4)

Dover, Delaware, United States
East Orange, New Jersey, United States
Cleveland, Ohio, United States
San Antonio, Texas, United States