The purpose of this study is to see if a mobile-delivered mental health program called Toivoa-001, which combines digital cognitive behavioral therapy (CBT) with personal mental health coaching, can effectively reduce anxiety in adults with hearing or mobility disabilities. The study aims to answer whether this dual-intervention digital service is more effective at lowering anxiety 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-001 program will show significantly greater reductions in anxiety 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 anxiety. By offering a fully remote and accessible mobile tool, this study seeks to determine if a digital health service can deliver scalable, effective anxiety relief tailored to the lived experiences of people with disabilities.

This pivotal, two-arm randomized clinical trial (RCT) will assess the efficacy of Toivoa-001, a mobile-delivered cognitive behavioral therapy (CBT) program tailored for people with disabilities, combined with National Board for Health and Wellness Coaching (NBHWC)-certified mental health coaching, in reducing anxiety symptoms compared to a sham digital program.

Recruitment will focus on adults with hearing or mobility disabilities, chosen to represent the broader U.S. disability community due to shared barriers to social participation, high prevalence of anxiety, and common co-morbidities. Anxiety in these populations often stems from environmental and societal barriers, such as limited accessibility, transportation challenges, and workplace inflexibility, rather than the medical condition alone.

Participants will be randomized to either intervention or control group.

The primary endpoint is change in evaluator-administered Hamilton Anxiety Rating Scale (HAM-A) from baseline to Week 8. Secondary endpoints include durability of effect at Week 12, Clinical Global Impression of Improvement (CGI-I) at Weeks 8 and 12, and proportion achieving a clinically meaningful response. Exploratory endpoints assess changes in depression (HAM-D) and self-reported anxiety (GAD-7) at Week 8.

Assessments will be conducted at baseline, mid-treatment, end of treatment (Week 8), and follow-up (Week 12). Self-report measures (PHQ-9, GAD-7) will be collected at baseline and biweekly during the intervention.

Recruitment will occur at up to 10 geographically dispersed U.S. sites, including Veterans Affairs healthcare facilities and academic institutions, using outreach through specialty clinics, events, and online platforms. The trial aims to enroll a diverse participant population without restrictions on gender, race, ethnicity, religion, or sexual orientation.

The study is designed to generate evidence on the effectiveness and durability of a dual-intervention approach, digital CBT plus mental health coaching, for anxiety reduction in people with disabilities, with potential implications for scalable, accessible mental health care delivery.

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
• Males and females; Age 22 years and above
• Score of 15 or higher on the HAM-A
• Clinical diagnosis of anxiety based on DSM-5 diagnostic criteria
• Willingness to adhere to the Toivoa-001 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

This study will be conducted in accordance with the following publication and data sharing policies and regulations:

Toivoa™ will share anonymized/de-identified clinical trial data and publish research outcomes in scientific journals, or present data at conferences. Considerations for ensuring confidentiality of these shared data are described in Section 10.1.2 and 10.1.3. We will implement a review process for clinical publications prior to submission for publication in journals or presentation at medical conferences.

As Responsible Party, Toivoa™ will share information about this/these trial(s) via timely registration updates, and results reporting in ClinicalTrials.gov. The informed consent documents used for this/these trial(s) will include statements to inform participants that information about the trial will be posted in ClinicalTrials.gov.

As Responsible Party, Toivoa™ will make the Study Protocol, Statistical Analysis Plan (SAP), and Informed Consent Form (ICF) available beginning 6 months following formal FDA clearance of the digital therapeutic and publication of the primary efficacy manuscript, whichever occurs later. These supporting documents will remain available to qualified researchers for a period of 3 years from that start date. The informed consent documents used for this trial include explicit statements informing participants of these data- and document-sharing practices.

Access to individual participant data (IPD) and supporting documents is controlled and limited to academic and clinical researchers engaging in independent, non-commercial scientific research. To request access, investigators must submit a formal, methodologically sound research proposal detailing the specific hypotheses and an independent statistical analysis plan (SAP). Requests will be reviewed and evaluated by Toivoa's leadership based on scientific merit, investigator qualifications, and ethical alignment. Approved requests will require the execution of a formal Data Use Agreement (DUA) that explicitly prohibits commercial exploitation, competitive asset weaponization, reverse-engineering of proprietary software or platform telemetry, or participant re-identification. Inquiries and proposals should be submitted directly to lranda@toivoa.us.

The randomization allocation of UC+Toivoa-001 versus UC+Sham will be done in random blocks of 2, 4, 6, and 8 subjects. As the study progresses, the blocking will be reduced to 2 and 4. This will provide relative balance over the course of the study while minimizing study personnel ability to predict the next randomization assignment. Monthly balance of randomization assignments will be reported, although the randomization assignments will be coded as A versus B to maintain blinding. Each site will randomize independently from other sites & maintain its own randomization schedule.

The study will be conducted as a double-blind study where both the participant & evaluators will not be aware of which study arm they have been assigned. Blinding assignments and onboarding instructions will be generated by the Site Administrator for a particular location. Blinding assignments will be made per site using procedures outside of the Rauha data platform and visible only to the Site Administrator.