Long CovidNCT07714889
Development of an Accessible Cognitive Behavioral Therapy Digital Therapeutic for Individuals With Long COVID
A study testing Rauha® Digital Therapeutic Platform (Toivoa-004) in people with Long Covid and Depression, run by Toivoa Inc.
Trial summary
This study will evaluate Toivoa-004 as an experimental digital therapeutic for persons with Long COVID suffering from anxiety or depression. This study will evaluate the completion rates of the Toivoa-004 program and survey the user's experience upon completion. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Long Covid, Depression, Anxiety
- What is being tested?
- Rauha® Digital Therapeutic Platform (Toivoa-004)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Presence of clinically diagnosed Long COVID.
- Stated willingness to comply with all study procedures and lifestyle considerations, and availability for the duration of the study.
- Males and females; Age 22 and above.
- Clinical Diagnosis of Long COVID
- Willingness to adhere to the study regiment.
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- Access to necessary resources for participating in a technology-based intervention (i.e., Phone, internet access).
- Able to read and speak English fluently.
- Resident of the US and living in the US for the duration of the study.
Who cannot join
- Self-reported substance use disorder. In the past 12 months (not including tobacco).
- Self-reported suicide attempts 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 or planning to become pregnant during the treatment period.
About this study
This study will evaluate Toivoa-004 as an experimental digital therapeutic for persons with Long COVID suffering from anxiety or depression. This study will evaluate the completion rates of the Toivoa-004 program and survey the user's experience upon completion. Changes in anxiety and depression scores will be monitored during the study.
Read the detailed description
There is an urgent unmet need for digital mental health interventions specifically designed for individuals suffering from Long COVID. In this research, we will evaluate a new digital intervention program designed specifically for those experiencing persistent mental health symptoms such as anxiety, depression, trauma, or cognitive dysfunction following COVID-19 infection. The intervention (called Toivoa-004) was created to meet the accessibility and personalization needs of this population and to introduce and measure the clinical impact of a cognitive behavioral therapy intervention combined with mental health coaching, tailored to the unique challenges faced by Long COVID patients and their caregivers.
Primary Objective: Assess the feasibility of participants remaining active users of the Toivoa-004 digital therapeutic over the 12-week study period. Active use will be described in terms of engagement with the platform's core modules as tracked by system analytics.
Exploratory Objective: Explore the usability, ease of use, and acceptability of Toivoa-004 by evaluating engagement with core therapeutic components. Data include usage metrics, satisfaction ratings, and qualitative feedback through in-app surveys and interviews.
- Conditions
- Long Covid, Depression, Anxiety
- Being tested
- Rauha® Digital Therapeutic Platform (Toivoa-004)
- Keywords
- Long COVID, Depression, Anxiety, Cognitive Behavioral Therapy, Digital Therapeutics, NBHWC, Health and Wellness Coaching
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rauha® Digital Therapeutic Platform (Toivoa-004)Device
A coach-delivered, WCAG 2.2 AA-accessible digital therapeutic targeting anxiety and depression symptom management in adults with clinically documented Long COVID. The platform integrates evidence-based behavioral health content delivered via the Rauha® Coach application.
| Study group | Role | What they receive |
|---|---|---|
| Toivoa-004 | Experimental | Not described Receives: Device: Rauha® Digital Therapeutic Platform (Toivoa-004) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of active users at Week 12
The primary endpoint is participant engagement with Toivoa-004, defined as the completion of at least 75% of the Toivoa-004 modules over the 12-week study period. Engagement will be measured via system analytics (module completions and usage logs). Feasibility will be considered achieved if more than 50% of enrolled participants meet this completion criterion.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: This study does not meet the clinical trial definition under FDAAA 801 / NIH policy - participants aren't prospectively assigned to an intervention, and no biomedical or behavioral outcome is evaluated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long CovidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toivoa Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714889
- Sponsor's protocol ID
- 00089210
- Other IDs
- 1R43NR021082-01A1
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared publicly. De-identified aggregate findings will be reported in peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Accessible Cognitive Behavioral Therapy Digital Therapeutic for Individuals With Long COVID
- ClinicalTrials.gov ID
- NCT07714889
- Acronym / sponsor ID
- 00089210
- Conditions
- Long Covid, Depression, Anxiety
- Keywords
- Long COVID, Depression, Anxiety, Cognitive Behavioral Therapy, Digital Therapeutics, NBHWC, Health and Wellness Coaching
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study does not meet the clinical trial definition under FDAAA 801 / NIH policy - participants aren't prospectively assigned to an intervention, and no biomedical or behavioral outcome is evaluated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Toivoa IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate Toivoa-004 as an experimental digital therapeutic for persons with Long COVID suffering from anxiety or depression. This study will evaluate the completion rates of the Toivoa-004 program and survey the user's experience upon completion. Changes in anxiety and depression scores will be monitored during the study.
Detailed description
There is an urgent unmet need for digital mental health interventions specifically designed for individuals suffering from Long COVID. In this research, we will evaluate a new digital intervention program designed specifically for those experiencing persistent mental health symptoms such as anxiety, depression, trauma, or cognitive dysfunction following COVID-19 infection. The intervention (called Toivoa-004) was created to meet the accessibility and personalization needs of this population and to introduce and measure the clinical impact of a cognitive behavioral therapy intervention combined with mental health coaching, tailored to the unique challenges faced by Long COVID patients and their caregivers.
Primary Objective: Assess the feasibility of participants remaining active users of the Toivoa-004 digital therapeutic over the 12-week study period. Active use will be described in terms of engagement with the platform's core modules as tracked by system analytics.
Exploratory Objective: Explore the usability, ease of use, and acceptability of Toivoa-004 by evaluating engagement with core therapeutic components. Data include usage metrics, satisfaction ratings, and qualitative feedback through in-app surveys and interviews.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toivoa-004 | Experimental | Device: Rauha® Digital Therapeutic Platform (Toivoa-004) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form.
- Presence of clinically diagnosed Long COVID.
- Stated willingness to comply with all study procedures and lifestyle considerations, and availability for the duration of the study.
- Males and females; Age 22 and above.
- Clinical Diagnosis of Long COVID
Key exclusion criteria (3 listed)
- Self-reported substance use disorder. In the past 12 months (not including tobacco).
- Self-reported suicide attempts 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 or planning to become pregnant during the treatment period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rauha® Digital Therapeutic Platform (Toivoa-004)A coach-delivered, WCAG 2.2 AA-accessible digital therapeutic targeting anxiety and depression symptom management in adults with clinically documented Long COVID. The platform integrates evidence-based behavioral health content delivered via the Rauha® Coach application. | Device | Toivoa-004 |
Primary outcome
Proportion of active users at Week 12
Time frame: 12 weeks
The primary endpoint is participant engagement with Toivoa-004, defined as the completion of at least 75% of the Toivoa-004 modules over the 12-week study period. Engagement will be measured via system analytics (module completions and usage logs). Feasibility will be considered achieved if more than 50% of enrolled participants meet this completion criterion.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. De-identified aggregate findings will be reported in peer-reviewed publications.
Related trials for Long Covid
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rauha® Digital Therapeutic Platform (Toivoa-004) in people with Long Covid and Depression, run by Toivoa Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of active users at Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.