Anxiety DepressionNCT06477913
Exploratory Study for Toivoa-001 on Human Factors
A study testing Rauha in people with Anxiety Depression and Disability Physical, run by Toivoa Inc at 1 site in United States.
Trial summary
The Study will evaluate Rauha as an experimental digital therapeutic for persons with Disabilities suffering from anxiety and/or depression. The study will evaluate completion rates of the 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
- Anxiety Depression, Disability Physical
- What is being tested?
- Rauha
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2024to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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 and above.
- 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).
- Willingness to adhere to the study regiment.
Show all 10Show fewer
- Access to necessary resources for participating in a technology-based intervention (i.e., iPhone, internet access).
- Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days before study entry).
- Able to read and speak English fluently.
- Resident of the US and living in the US for the duration of the trial. -
Who cannot join
- 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 (not including 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 or planning to become pregnant during the treatment period. -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Steven A. Cohen Military Family Clinic at Endeavors
San Antonio, Texas, 78249
About this study
Official title: Exploratory Study for Reduction of Anxiety and Depression Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy and National Board Health and Wellness Coaches (NBHWC) For People With Disabilities
The Study will evaluate Rauha as an experimental digital therapeutic for persons with Disabilities suffering from anxiety and/or depression. The study will evaluate completion rates of the 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
The Investigators propose a single-arm controlled trial evaluating (Rauha) plus usual care as an intervention for persons actively seeking treatment for anxiety and/or depression. Recruitment will occur at a single US health facility where approximately 30 adults with disabilities and clinically elevated anxiety and/or depressive symptoms will be we will recruited and enrolled. Eligible participants will be administered Rauha as a remote app with site oversight. Patients will be monitored and encouraged by Mental Health Coaches to complete the therapy. Mental Health Coaches will also provide instruction on completion of modules. Patients will engage with the Rauha app, have the opportunity to complete all 33 modules, receive Mental Health Coach support, and engage with the online community for a total of 8 weeks. The community forum feature will provide patients access to a community forum that understands the specific struggles of the condition, allowing users to interact with one another via an online community designed for empowerment and support. Support from a Mental Health Coach will be provided at prescribed intervals and will also be available to each participant in addition to access to the online community. A participant is considered to have completed the study if he or she has completed all assessments. The end of the study is defined as completion of the 4 week follow-up assessment
- Conditions
- Anxiety Depression, Disability Physical
- Being tested
- Rauha
- Keywords
- Digital Therapeutics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RauhaDevice
Also called Toivoa-001
A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Mental Health Coaches
| Study group | Role | What they receive |
|---|---|---|
| Active Rauha Therapy | Experimental | Qualified intend to treat (ITT) population evaluating Rauha and access to Mental Health Coaches Receives: Device: Rauha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rates as a Percentage of Enrolled Participants
Assess the proportion of the Intent to Treat population who remain active users of the program at the end of the 8-week primary study period. Completion rates will be reported as the percentage of enrolled users who continue to engage with the digital therapy per week.
Measured: 8 weeks
Secondary outcomes (4)
Changes in Hamilton Anxiety Rating Scale (HAM-A) Scores Following Therapy
The Hamilton Anxiety Rating Scale (HAM-A) is a structured interview assessing anxiety symptoms using 14 items, each rated from 0 ("not present") to 4 ("severe"). Scores range from 0 to 56 with higher scores indicating more severe anxiety. Changes in HAM-A scores will be measured between two timepoints at Baseline and 8 weeks.
Measured: 8 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) Scores Following Therapy
The Hamilton Depression Rating Scale (HAM-D) is a structured interview assessing depression based on 17 items; items range from 0 ("not present") to 4 ("severe") and 0 ("absent") to 2 ("severe"). Total scores range 0 to 54 with higher scores indicating more severe depression. Changes in HAM-D scores will be measured between two timepoints at Baseline and 8 weeks.
Measured: 8 weeks
Changes in Hamilton Anxiety Rating Scale (HAM-A) Scores 4 Weeks Post-therapy
The Hamilton Anxiety Rating Scale (HAM-A) is a structured interview assessing anxiety symptoms using 14 items, each rated from 0 ("not present") to 4 ("severe"). Scores range from 0 to 56 with higher scores indicating more severe anxiety. Changes in HAM-A scores will be measured between two timepoints at Baseline and 12 weeks.
Measured: 12 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) Scores 4 Weeks Post-therapy
The Hamilton Depression Rating Scale (HAM-D) is a structured interview assessing depression based on 17 items; items range from 0 ("not present") to 4 ("severe") and 0 ("absent") to 2 ("severe"). Total scores range 0 to 54 with higher scores indicating more severe depression. Changes in HAM-D scores will be measured between two timepoints at Baseline and 12 weeks.
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 posted27 Jun 2024
- Study start11 Jul 2024
- Primary completion27 Dec 2024
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety DepressionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toivoa Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Family Endeavors, Inc DBA Endeavors, Advarra
- Responsible party
- Sponsor
- Investigators
- Jill Palmer, Principal investigator, Collaborator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477913
- Sponsor's protocol ID
- TDX01
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2024
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study for Reduction of Anxiety and Depression Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy and National Board Health and Wellness Coaches (NBHWC) For People With Disabilities
- ClinicalTrials.gov ID
- NCT06477913
- Acronym / sponsor ID
- TDX01
- Conditions
- Anxiety Depression, Disability Physical
- Keywords
- Digital Therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Toivoa IncIndustry (pharma, biotech, devices)
- Collaborators
- Family Endeavors, Inc DBA Endeavors, Advarra
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Posted 21 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Study will evaluate Rauha as an experimental digital therapeutic for persons with Disabilities suffering from anxiety and/or depression. The study will evaluate completion rates of the program and survey the user's experience upon completion. Changes in anxiety and depression scores will be monitored during the study.
Detailed description
The Investigators propose a single-arm controlled trial evaluating (Rauha) plus usual care as an intervention for persons actively seeking treatment for anxiety and/or depression. Recruitment will occur at a single US health facility where approximately 30 adults with disabilities and clinically elevated anxiety and/or depressive symptoms will be we will recruited and enrolled. Eligible participants will be administered Rauha as a remote app with site oversight. Patients will be monitored and encouraged by Mental Health Coaches to complete the therapy. Mental Health Coaches will also provide instruction on completion of modules. Patients will engage with the Rauha app, have the opportunity to complete all 33 modules, receive Mental Health Coach support, and engage with the online community for a total of 8 weeks. The community forum feature will provide patients access to a community forum that understands the specific struggles of the condition, allowing users to interact with one another via an online community designed for empowerment and support. Support from a Mental Health Coach will be provided at prescribed intervals and will also be available to each participant in addition to access to the online community. A participant is considered to have completed the study if he or she has completed all assessments. The end of the study is defined as completion of the 4 week follow-up assessment
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Rauha Therapy | Experimental | Device: RauhaQualified intend to treat (ITT) population evaluating Rauha and access to Mental Health Coaches |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 and above.
- 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).
Key exclusion criteria (5 listed)
- 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 (not including 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 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 |
|---|---|---|
| RauhaAlso: Toivoa-001A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Mental Health Coaches | Device | Active Rauha Therapy |
Primary outcome
Completion Rates as a Percentage of Enrolled Participants
Time frame: 8 weeks
Assess the proportion of the Intent to Treat population who remain active users of the program at the end of the 8-week primary study period. Completion rates will be reported as the percentage of enrolled users who continue to engage with the digital therapy per week.
4 secondary outcomes
Changes in Hamilton Anxiety Rating Scale (HAM-A) Scores Following Therapy
Time frame: 8 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) Scores Following Therapy
Time frame: 8 weeks
Changes in Hamilton Anxiety Rating Scale (HAM-A) Scores 4 Weeks Post-therapy
Time frame: 12 weeks
Changes in Hamilton Depression Rating Scale (HAM-D) Scores 4 Weeks Post-therapy
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jill Palmer principal investigator
Collaborator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rauha in people with Anxiety Depression and Disability Physical, run by Toivoa Inc at 1 site in United States.
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 10 inclusion and 5 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: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 21 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Completion Rates as a Percentage of Enrolled Participants (time frame: 8 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 21 Aug 2026.