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Reducing Anxiety in People with Disabilities Through Digital CBT & Coaching

This study is testing if a mobile program called Toivoa-001 can help reduce anxiety in adults with hearing or mobility disabilities. Toivoa-001 combines digital cognitive behavioral therapy (CBT), a type of talk therapy, with personal coaching. Researchers want to see if Toivoa-001 is more effective at lowering anxiety over 8 weeks compared to a general health education program. To join, you need to be at least 22 years old, have a self-reported hearing or mobility disability, and have a clinical diagnosis of anxiety with a specific anxiety score (HAM-A score of 15 or higher). The study aims to enroll 200 participants, but its current recruitment status is unclear.

Study design
This is a randomized clinical trial, meaning participants will be randomly assigned to either receive the Toivoa-001 program or a general health education program. The study plans to enroll 200 participants.
What's involved
Participants will use a digital program for 8 weeks. Anxiety levels will be measured at the beginning and end of this 8-week period.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check on participants' anxiety levels again 12 weeks after the treatment period ends to see if the benefits last.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07140497

Reduction of Anxiety Through Dual Treatment: Digital CBT & NBHWC Coaching

Not Yet Recruiting
NAAges 22+InterventionalTreatment
Toivoa Inc
~200 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT.Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8
Measured over From Baseline to end of treatment (8 weeks)

Conditions

Hearing Disability
Anxiety
Mobility Disability

Explore related trials

Ability to mobilizeAnxietyLearning disability

NCT07140497

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Delaware State University

    Dover, Delawarestudy coordinator listed

  • Louis Stokes Cleveland VAMC

    Cleveland, Ohiostudy coordinator listed

  • New Jersey Department of Veterans Health

    East Orange, New Jerseystudy coordinator listed

  • South Texas Veterans Health Care System

    San Antonio, Texasstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Laura Randa
[email protected]
612-237-5896
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8From Baseline to end of treatment (8 weeks)

    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.