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NOT YET RECRUITING
NCT07140497
NA

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

Sponsor: Toivoa Inc

View on ClinicalTrials.gov

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.

Official title: Reduction of Anxiety Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy (CBT) and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches for People With Disabilities (RADD)

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-08

Completion Date

2027-08

Last Updated

2026-07-16

Healthy Volunteers

No

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

Locations (4)

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