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

Toivoa Inc

Status: Begins enrollment this month

Conditions: Mobility Disability; Hearing Disability; Anxiety

Treatments: Device: Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.; Device: Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT.

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency; Other

Identifiers

NCT07140497

Private Funding (Other Identifier)

00074059

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Toivoa-001 Digital CBT + NBHWC Coaching

Active Comparator group

Description:

Participants in this arm receive a dual mental health treatment via a secure mobile app, including 8 psychoeducational modules and weekly one-on-one sessions with a National Board for Health \& Wellness Coaching (NBHWC)-certified coach. Modules focus on goal-setting, behavioral activation, cognitive restructuring, and interpersonal skill-building, with interactive exercises and opportunities for reinforcement. While the program is structured for one module per week over 8 consecutive weeks, participants may engage more flexibly in as little as 5-minute increments. ALL INVITED PARTICIPANTS: Following baseline assessments, study participants will be randomized by the site administrator and then invited to join either the Toivoa-001 (therapy) or sham (control) through a meeting invitation. The invitation will include instructions to download and register for the app, and contact information for their coach or assessor.

Treatment:

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

General Health Education + Interactive Quizzes

Sham Comparator group

Description:

Participants randomized to the sham comparator receive an 8-week digital program featuring general health and wellness information with interactive quizzes. This content is not related to anxiety treatment or CBT techniques. The arm is designed to mirror the Toivoa-001 arm in duration and engagement, ensuring parity in attention without therapeutic intent.

Treatment:

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