Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coac… (NCT07140497) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching - A Randomized Clinical Trial
United States200 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8
Timeframe: From Baseline to end of treatment (8 weeks)