Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching - A Randomized Clinical Trial

Summary

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.

Conditions

• Hearing Disability
• Anxiety
• Mobility Disability

Interventions

DEVICE

Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT.

General health and wellness information with interactive quizzes. This content is not related to anxiety treatment or CBT techniques.

DEVICE

Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.

A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Coaches

Sponsors & Collaborators

• Delaware State University

  collaborator UNKNOWN

• VA New Jersey Health Care System

  collaborator FED

• South Texas Veterans Health Care System

  collaborator FED

• Louis Stokes VA Medical Center

  collaborator FED

• Toivoa Inc

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2027-08-31

Completion

2027-08-31

FDA Device

Yes

Countries

• United States

Study Locations