Smartphone therapy may ease anxiety for those with disabilities
NCT ID NCT07140497
First seen Jul 02, 2026 · Last updated Sep 15, 2026 · Updated 10 times
Summary
This study tests whether a mobile app that combines digital cognitive behavioral therapy (CBT) with personal mental health coaching can reduce anxiety in adults with hearing or mobility disabilities. Participants use either the active program or a sham version for 8 weeks, with follow-up at 12 weeks. The goal is to see if a fully remote, accessible tool can provide lasting anxiety relief for a group that often faces extra barriers to mental health care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- digital cognitive behavioral therapy (CBT) plus mental health coaching
- What this could lead to
- If effective, this could offer a scalable, remote anxiety treatment tailored for people with disabilities who face unique barriers to care.
- What could go wrong
- This is an early-stage study with a sham comparator, and results may not generalize beyond the specific disability groups or program design.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Delaware State University
Dover, Delaware, 19904, United States
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Louis Stokes Cleveland VAMC
Cleveland, Ohio, 44106, United States
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New Jersey Department of Veterans Health
East Orange, New Jersey, 07018, United States
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South Texas Veterans Health Care System
San Antonio, Texas, 78229, United States
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