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

NCT07140497 | Not Yet Recruiting FDA Device

• 2 other identifiers: 00074059Private Funding
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Anxiety; People with Hearing or Mobility Disability; Accessible Health for People with Disabilities and Veterans; Cognitive Behavioral Therapy; Cognitive Behavioral Therapy with Coaches; Coaches

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8

  The Hamilton Anxiety Rating Scale (HAM-A) is a structured interview using 14 items, each rated from 0 ("not present") to 4 ("severe"). Scores range from 0 to 56. Analyses will use a mixed model for repeated measures (MMRM) in the Intent-to-Treat (ITT) population. The MMRM will model change from Baseline and Weeks 4 and 8 as repeated post-baseline measurements. The model will include fixed effects for treatment group, visit, treatment-by-visit interaction, study site, and Baseline HAM-A total score as a covariate. Within-participant correlation across repeated measurements will be modeled using an appropriate covariance structure. The primary treatment comparison will be the difference between treatment groups in least squares mean change from Baseline to Week 8. Statistical significance for the primary endpoint will be assessed based on the Week 8 treatment contrast from the MMRM. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.

  From Baseline to end of treatment (8 weeks)

Secondary Outcomes (4)

• Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 12

  From Baseline to 4 weeks after treatment (12 weeks)

• Clinical Global Impression for Improvement (CGI-I) at Week 8

  From Baseline to end of treatment (8 weeks)

• Clinical Global Impression for Improvement (CGI-I) at Week 12

  From Baseline to 4 weeks after treatment (12 weeks)

• Proportion of participants achieving clinically meaningful response on Hamilton Anxiety Rating Scale (HAM-A) at Week 8

  From Baseline to end of treatment (8 weeks)

Other Outcomes (2)

• Change in Hamilton Depression Rating Scale (HAM-D) from Baseline to Week 8

  From Baseline to end of treatment (8 weeks)

• Change in Generalized Anxiety Disorder-7 (GAD-7) from baseline to Week 8

  From Baseline to end of treatment (8 weeks)

Study Arms (2)

Toivoa-001 Digital CBT + NBHWC Coaching

ACTIVE COMPARATOR

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.

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

General Health Education + Interactive Quizzes

SHAM COMPARATOR

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.

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

Interventions

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

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

General Health Education + Interactive Quizzes

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

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

Toivoa-001 Digital CBT + NBHWC Coaching

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA New Jersey Health Care System: collaborator
• South Texas Veterans Health Care System: collaborator
• Louis Stokes VA Medical Center: collaborator
• Toivoa Inc: lead
• Delaware State University: collaborator

Study Sites (4)

Delaware State University

Dover, Delaware, 19904, United States

Location

New Jersey Department of Veterans Health

East Orange, New Jersey, 07018, United States

Location

Louis Stokes Cleveland VAMC

Cleveland, Ohio, 44106, United States

Location

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

Location

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MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Laura Randa

CONTACT

612-237-5896; lranda@toivoa.us

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 24, 2025
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 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 Criteria: 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.

Locations

US (4)