Can a smartphone program ease anxiety and depression in people with disabilities?

NCT ID NCT06477913

The trial has finished. Results may not be published yet.

First seen Aug 21, 2026 ยท Last updated Aug 21, 2026

Summary

This study tests a digital program called Rauha that combines online cognitive behavioral therapy with coaching from trained mental health coaches. It is designed for adults with hearing or mobility disabilities who also experience anxiety or depression. The trial will see if people stick with the program and whether their anxiety and depression symptoms improve over eight weeks.

What this could mean

Our plain-language read of the trial. This is informational only โ€” not medical advice or a prediction.

Active substance
Rauha (Toivoa-001), a digital therapeutic combining online cognitive behavioral therapy with mental health coaching
What this could lead to
If successful, this could offer a new, accessible way to help people with disabilities manage anxiety and depression.
What could go wrong
This is a small exploratory study, so results may not apply broadly. The program's effectiveness and safety are not yet proven.

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

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

13 people

The number who actually took part.

Started

Jul 2024

Finished

Jan 2025

Lead sponsor

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

22 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Presence of self-reported hearing or mobility disability. 3. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study. 4. Males and females; Age 22 and above. 5. Score of 10 or greater on the Patient Health Questionnaire-9 (PHQ-9) or Generalized Anxiety Disorder-7 (GAD-7) (to be assessed post-study-specific screening consent). 6. Willingness to adhere to the study regiment. 7. Access to necessary resources for participating in a technology-based intervention (i.e., iPhone, internet access). 8. Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days before study entry). 9. Able to read and speak English fluently. 10. Resident of the US and living in the US for the duration of the trial. - Exclusion Criteria: 1. Medical diagnosis of psychotic disorder or bipolar disorder. 2. Participation in another treatment trial at the time of study. 3. Substance use disorder. In the past 12 months (not including tobacco). 4. 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). 5. Currently pregnant 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.

Contacts and locations

Locations

  • The Steven A. Cohen Military Family Clinic at Endeavors

    San Antonio, Texas, 78249, United States

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