Hearing DisabilityNCT07140497

Reduction of Anxiety Through Dual Treatment: Digital CBT & NBHWC Coaching

A study testing Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching. in people with Hearing Disability and Anxiety, run by Toivoa Inc at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 22 years and older
Conditions the study is for: Hearing Disability, Anxiety, Mobility Disability
What is being tested?: Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 4 sitesUnited States
Study dates: Sep 2026to Aug 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 years and above
Score of 15 or higher on the HAM-A
Clinical diagnosis of anxiety based on DSM-5 diagnostic criteria

Show all 11Show fewer

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

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 (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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laura Randa contact

612-237-5896

lranda@toivoa.us

United States4 sites

Louis Stokes Cleveland VAMC
Cleveland, Ohio, 44106
MaryAnn Richmond, MD, 216-791-3800, maryann.richmond@va.gov
MaryAnn Richmond, MD
Delaware State University
Dover, Delaware, 19904
Rosemarie White, DNP, CRNP-PMH, PMHNP-BC, 302-760-1977, rawhite@desu.edu
Gwendolyn Scott-Jones, PsyD, 302-736-2364, gscottjones@desu.edu
New Jersey Department of Veterans Health
East Orange, New Jersey, 07018
Carol M Gibson-Gill, MD, MSCS, VHA-CM, 973-676-1000 ext. 201564, carol.gibson-gill@va.gov
Carol M Gibson-Gill, MD
South Texas Veterans Health Care System
San Antonio, Texas, 78229
Alicia A Swan, PhD, 210-517-5541, alicia.swan@va.gov
Alicia A Swan, PhD

Other trials in United States

About this study

Official title: Reduction of Anxiety Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches

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.

Read the detailed description

This pivotal, two-arm randomized clinical trial (RCT) will assess the efficacy of Toivoa-001, a mobile-delivered cognitive behavioral therapy (CBT) program tailored for people with disabilities, combined with National Board for Health and Wellness Coaching (NBHWC)-certified mental health coaching, in reducing anxiety symptoms compared to a sham digital program.

Recruitment will focus on adults with hearing or mobility disabilities, chosen to represent the broader U.S. disability community due to shared barriers to social participation, high prevalence of anxiety, and common co-morbidities. Anxiety in these populations often stems from environmental and societal barriers, such as limited accessibility, transportation challenges, and workplace inflexibility, rather than the medical condition alone.

Participants will be randomized to either intervention or control group.

The primary endpoint is change in evaluator-administered Hamilton Anxiety Rating Scale (HAM-A) from baseline to Week 8. Secondary endpoints include durability of effect at Week 12, Clinical Global Impression of Improvement (CGI-I) at Weeks 8 and 12, and proportion achieving a clinically meaningful response. Exploratory endpoints assess changes in depression (HAM-D) and self-reported anxiety (GAD-7) at Week 8.

Assessments will be conducted at baseline, mid-treatment, end of treatment (Week 8), and follow-up (Week 12). Self-report measures (PHQ-9, GAD-7) will be collected at baseline and biweekly during the intervention.

Recruitment will occur at up to 10 geographically dispersed U.S. sites, including Veterans Affairs healthcare facilities and academic institutions, using outreach through specialty clinics, events, and online platforms. The trial aims to enroll a diverse participant population without restrictions on gender, race, ethnicity, religion, or sexual orientation.

The study is designed to generate evidence on the effectiveness and durability of a dual-intervention approach, digital CBT plus mental health coaching, for anxiety reduction in people with disabilities, with potential implications for scalable, accessible mental health care delivery.

Conditions: Hearing Disability, Anxiety, Mobility Disability
Being tested: Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT., Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.
Keywords: Anxiety, People with Hearing or Mobility Disability, Accessible Health for People with Disabilities and Veterans, Cognitive Behavioral Therapy, Cognitive Behavioral Therapy with Coaches, Coaches
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT.Device
General health and wellness information with interactive quizzes. This content is not related to anxiety treatment or CBT techniques.
Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.Device
A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Coaches

Study groups in NCT07140497
Study group	Role	What they receive
Toivoa-001 Digital CBT + NBHWC Coaching	Active comparator	Participants in this arm receive a dual mental health treatment via a secure mobile app, including 8 psychoeducational modules and weekly one-on-one sessions with a National Board for Health \& Wellness Coaching (NBHWC)-certified coach. Modules focus on goal-setting, behavioral activation, cognitive restructuring, and interpersonal skill-building, with interactive exercises and opportunities for reinforcement. While the program is structured for one module per week over 8 consecutive weeks, participants may engage more flexibly in as little as 5-minute increments. ALL INVITED PARTICIPANTS: Following baseline assessments, study participants will be randomized by the site administrator and then invited to join either the Toivoa-001 (therapy) or sham (control) through a meeting invitation. The invitation will include instructions to download and register for the app, and contact information for their coach or assessor. Receives: Device: Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.
General Health Education + Interactive Quizzes	Sham comparator	Participants randomized to the sham comparator receive an 8-week digital program featuring general health and wellness information with interactive quizzes. This content is not related to anxiety treatment or CBT techniques. The arm is designed to mirror the Toivoa-001 arm in duration and engagement, ensuring parity in attention without therapeutic intent. Receives: Device: Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8
The Hamilton Anxiety Rating Scale (HAM-A) is a structured interview using 14 items, each rated from 0 ("not present") to 4 ("severe"). Scores range from 0 to 56. Analyses will use a mixed model for repeated measures (MMRM) in the Intent-to-Treat (ITT) population. The MMRM will model change from Baseline and Weeks 4 and 8 as repeated post-baseline measurements. The model will include fixed effects for treatment group, visit, treatment-by-visit interaction, study site, and Baseline HAM-A total score as a covariate. Within-participant correlation across repeated measurements will be modeled using an appropriate covariance structure. The primary treatment comparison will be the difference between treatment groups in least squares mean change from Baseline to Week 8. Statistical significance for the primary endpoint will be assessed based on the Week 8 treatment contrast from the MMRM. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.
Measured: From Baseline to end of treatment (8 weeks)

Secondary outcomes (4)

Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 12
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. Change from Baseline to Week 12 in HAM-A total score will be analyzed using an MMRM analogous to that used for the primary endpoint. The model will include fixed effects for treatment group, visit, treatment-by-visit interaction, and study site, with Baseline Assessments HAM-A total score included as a covariate. Post-baseline assessments at Weeks 4, 8, and 12 will be included in the model. The treatment comparison of interest will be the between-group difference in least squares mean change from Baseline Assessments at Week 12. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.
Measured: From Baseline to 4 weeks after treatment (12 weeks)
Clinical Global Impression for Improvement (CGI-I) at Week 8
The Clinical Global Impression for Improvement (CGI-I) is a evaluator-rated scale to assess how much a patient's illness has improved or worsened relative to baseline. It assesses overall clinical change based on a single item rated from 1 ("very much improved") to 7 ("very much worse"). CGI-I at Week 8 will be analyzed using an MMRM including fixed effects for treatment group, visit, treatment-by-visit interaction, and study site. Because CGI-I is not measured at baseline, no baseline covariate will be included in the model. Post-baseline assessments at Weeks 4 and 8 will be included. Although CGI-I is an ordinal endpoint, it will be analyzed as a continuous variable for this study. The treatment comparison of interest will be the between-group difference in least squares mean score at Week 8. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.
Measured: From Baseline to end of treatment (8 weeks)
Clinical Global Impression for Improvement (CGI-I) at Week 12
The Clinical Global Impression for Improvement (CGI-I) is a evaluator-rated scale to assess how much a patient's illness has improved or worsened relative to baseline. It assesses overall clinical change based on a single item rated from 1 ("very much improved") to 7 ("very much worse"). CGI-I at Week 12 will be analyzed using an MMRM including fixed effects for treatment group, visit, treatment-by-visit interaction, and study site. Because CGI-I is not measured at baseline, no baseline covariate will be included in the model. Post-baseline assessments at Weeks 4, 8 and 12 will be included. Although CGI-I is an ordinal endpoint, it will be analyzed as a continuous variable for this study. The treatment comparison of interest will be the between-group difference in least squares mean score at Week 8. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.
Measured: From Baseline to 4 weeks after treatment (12 weeks)
Proportion of participants achieving clinically meaningful response on Hamilton Anxiety Rating Scale (HAM-A) at Week 8
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. HAM-A response at Week 8, defined as a reduction of at least 4 points from Baseline Assessments in HAM-A total score, will be analyzed using Week 8 data only. Participants without a Week 8 assessment will be classified as non-responders. Response rates will be summarized by treatment group and compared using Pearson's chi-square test. The between-group difference in response rate and its 95% confidence interval will also be provided.
Measured: From Baseline to end of treatment (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2026Aug 2027

First posted24 Aug 2025
Study startSep 2026 (estimated)
Primary completionAug 2027 (estimated)
Study completionAug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Hearing DisabilityStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07140497
Sponsor's protocol ID: 00074059
Other IDs: Private Funding
Status last verified: Jul 2026
First submitted: 18 Jul 2025
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: This study will be conducted in accordance with the following publication and data sharing policies and regulations: Toivoa™ will share anonymized/de-identified clinical trial data and publish research outcomes in scientific journals, or present data at conferences. Considerations for ensuring confidentiality of these shared data are described in Section 10.1.2 and 10.1.3. We will implement a review process for clinical publications prior to submission for publication in journals or presentation at medical conferences. As Responsible Party, Toivoa™ will share information about this/these trial(s) via timely registration updates, and results reporting in ClinicalTrials.gov. The informed consent documents used for this/these trial(s) will include statements to inform participants that information about the trial will be posted in ClinicalTrials.gov.

Publications

Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. doi: 10.1001/archpsyc.1988.01800320058007.
PubMed 3395203
Therneau TM. How many stratification factors are "too many" to use in a randomization plan? Control Clin Trials. 1993 Apr;14(2):98-108. doi: 10.1016/0197-2456(93)90013-4.
PubMed 8500309
Ten Have TR, Kunselman AR, Pulkstenis EP, Landis JR. Mixed effects logistic regression models for longitudinal binary response data with informative drop-out. Biometrics. 1998 Mar;54(1):367-83.
PubMed 9544529
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171
Segal ZV, Dimidjian S, Beck A, Boggs JM, Vanderkruik R, Metcalf CA, Gallop R, Felder JN, Levy J. Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001/jamapsychiatry.2019.4693.
PubMed 31995132
Scott KM, Von Korff M, Alonso J, Angermeyer MC, Bromet E, Fayyad J, de Girolamo G, Demyttenaere K, Gasquet I, Gureje O, Haro JM, He Y, Kessler RC, Levinson D, Medina Mora ME, Oakley Browne M, Ormel J, Posada-Villa J, Watanabe M, Williams D. Mental-physical co-morbidity and its relationship with disability: results from the World Mental Health Surveys. Psychol Med. 2009 Jan;39(1):33-43. doi: 10.1017/S0033291708003188. Epub 2008 Mar 26.
PubMed 18366819
Reimherr FW, Amsterdam JD, Quitkin FM, Rosenbaum JF, Fava M, Zajecka J, Beasley CM Jr, Michelson D, Roback P, Sundell K. Optimal length of continuation therapy in depression: a prospective assessment during long-term fluoxetine treatment. Am J Psychiatry. 1998 Sep;155(9):1247-53. doi: 10.1176/ajp.155.9.1247.
PubMed 9734550
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
PubMed 22193671
Maier W, Buller R, Philipp M, Heuser I. The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord. 1988 Jan-Feb;14(1):61-8. doi: 10.1016/0165-0327(88)90072-9.
PubMed 2963053
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
Katz I, Barry CN, Cooper SA, Kasprow WJ, Hoff RA. Use of the Columbia-Suicide Severity Rating Scale (C-SSRS) in a large sample of Veterans receiving mental health services in the Veterans Health Administration. Suicide Life Threat Behav. 2020 Feb;50(1):111-121. doi: 10.1111/sltb.12584. Epub 2019 Aug 23.
PubMed 31441952
Hill KG, Woodward D, Woelfel T, Hawkins JD, Green S. Planning for Long-Term Follow-Up: Strategies Learned from Longitudinal Studies. Prev Sci. 2016 Oct;17(7):806-18. doi: 10.1007/s11121-015-0610-7.
PubMed 26453453
Han B, Enas NH, McEntegart D. Randomization by minimization for unbalanced treatment allocation. Stat Med. 2009 Nov 30;28(27):3329-46. doi: 10.1002/sim.3710.
PubMed 19739238
Gottfredson NC, Bauer DJ, Baldwin SA, Okiishi JC. Using a shared parameter mixture model to estimate change during treatment when termination is related to recovery speed. J Consult Clin Psychol. 2014 Oct;82(5):813-27. doi: 10.1037/a0034831. Epub 2013 Nov 25.
PubMed 24274626
Gibbons RD, Hedeker D, Elkin I, Waternaux C, Kraemer HC, Greenhouse JB, Shea MT, Imber SD, Sotsky SM, Watkins JT. Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Application to the NIMH treatment of Depression Collaborative Research Program dataset. Arch Gen Psychiatry. 1993 Sep;50(9):739-50. doi: 10.1001/archpsyc.1993.01820210073009.
PubMed 8357299

Interested in taking part?

Laura Randa

612-237-5896

lranda@toivoa.us

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hearing Disability trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reduction of Anxiety Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches
ClinicalTrials.gov ID: NCT07140497
Acronym / sponsor ID: 00074059
Conditions: Hearing Disability, Anxiety, Mobility Disability
Keywords: Anxiety, People with Hearing or Mobility Disability, Accessible Health for People with Disabilities and Veterans, Cognitive Behavioral Therapy, Cognitive Behavioral Therapy with Coaches, Coaches
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: Toivoa IncIndustry (pharma, biotech, devices)
Collaborators: Delaware State University, VA New Jersey Health Care System, South Texas Veterans Health Care System, Louis Stokes VA Medical Center
Study start: Sep 2026 (estimated)
Primary completion: Aug 2027 (estimated)
Study completion: Aug 2027 (estimated)
First posted: 24 Aug 2025 (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.

Detailed description

Participants will be randomized to either intervention or control group.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Toivoa-001 Digital CBT + NBHWC Coaching	Active comparator	Device: Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.Participants in this arm receive a dual mental health treatment via a secure mobile app, including 8 psychoeducational modules and weekly one-on-one sessions with a National Board for Health \& Wellness Coaching (NBHWC)-certified coach. Modules focus on goal-setting, behavioral activation, cognitive restructuring, and interpersonal skill-building, with interactive exercises and opportunities for reinforcement. While the program is structured for one module per week over 8 consecutive weeks, participants may engage more flexibly in as little as 5-minute increments. ALL INVITED PARTICIPANTS: Following baseline assessments, study participants will be randomized by the site administrator and then invited to join either the Toivoa-001 (therapy) or sham (control) through a meeting invitation. The invitation will include instructions to download and register for the app, and contact information for their coach or assessor.
General Health Education + Interactive Quizzes	Sham comparator	Device: Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT.Participants randomized to the sham comparator receive an 8-week digital program featuring general health and wellness information with interactive quizzes. This content is not related to anxiety treatment or CBT techniques. The arm is designed to mirror the Toivoa-001 arm in duration and engagement, ensuring parity in attention without therapeutic intent.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 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 years and above
Score of 15 or higher on the HAM-A

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 (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

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
Sham Digital Program - General health education and interactive quizzes unrelated to anxiety or CBT.General health and wellness information with interactive quizzes. This content is not related to anxiety treatment or CBT techniques.	Device	General Health Education + Interactive Quizzes
Toivoa-001 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.A dual mental health treatment consisting of digitally-administered Cognitive Behavioral Therapy combined with National Board Health and Wellness Coach (NBHWC) trained Coaches	Device	Toivoa-001 Digital CBT + NBHWC Coaching

Primary outcome

Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8
Time frame: From Baseline to end of treatment (8 weeks)
The Hamilton Anxiety Rating Scale (HAM-A) is a structured interview using 14 items, each rated from 0 ("not present") to 4 ("severe"). Scores range from 0 to 56. Analyses will use a mixed model for repeated measures (MMRM) in the Intent-to-Treat (ITT) population. The MMRM will model change from Baseline and Weeks 4 and 8 as repeated post-baseline measurements. The model will include fixed effects for treatment group, visit, treatment-by-visit interaction, study site, and Baseline HAM-A total score as a covariate. Within-participant correlation across repeated measurements will be modeled using an appropriate covariance structure. The primary treatment comparison will be the difference between treatment groups in least squares mean change from Baseline to Week 8. Statistical significance for the primary endpoint will be assessed based on the Week 8 treatment contrast from the MMRM. The estimated treatment difference, 95% confidence interval, and two-sided p-value will be reported.

4 secondary outcomes

Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 12
Time frame: From Baseline to 4 weeks after treatment (12 weeks)
Clinical Global Impression for Improvement (CGI-I) at Week 8
Time frame: From Baseline to end of treatment (8 weeks)
Clinical Global Impression for Improvement (CGI-I) at Week 12
Time frame: From Baseline to 4 weeks after treatment (12 weeks)
Proportion of participants achieving clinically meaningful response on Hamilton Anxiety Rating Scale (HAM-A) at Week 8
Time frame: From Baseline to end of treatment (8 weeks)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Background: PubMed 3395203Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. doi: 10.1001/archpsyc.1988.01800320058007.
Background: PubMed 8500309Therneau TM. How many stratification factors are "too many" to use in a randomization plan? Control Clin Trials. 1993 Apr;14(2):98-108. doi: 10.1016/0197-2456(93)90013-4.
Background: PubMed 9544529Ten Have TR, Kunselman AR, Pulkstenis EP, Landis JR. Mixed effects logistic regression models for longitudinal binary response data with informative drop-out. Biometrics. 1998 Mar;54(1):367-83.
Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Background: PubMed 31995132Segal ZV, Dimidjian S, Beck A, Boggs JM, Vanderkruik R, Metcalf CA, Gallop R, Felder JN, Levy J. Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001/jamapsychiatry.2019.4693.
Background: PubMed 18366819Scott KM, Von Korff M, Alonso J, Angermeyer MC, Bromet E, Fayyad J, de Girolamo G, Demyttenaere K, Gasquet I, Gureje O, Haro JM, He Y, Kessler RC, Levinson D, Medina Mora ME, Oakley Browne M, Ormel J, Posada-Villa J, Watanabe M, Williams D. Mental-physical co-morbidity and its relationship with disability: results from the World Mental Health Surveys. Psychol Med. 2009 Jan;39(1):33-43. doi: 10.1017/S0033291708003188. Epub 2008 Mar 26.
Background: PubMed 9734550Reimherr FW, Amsterdam JD, Quitkin FM, Rosenbaum JF, Fava M, Zajecka J, Beasley CM Jr, Michelson D, Roback P, Sundell K. Optimal length of continuation therapy in depression: a prospective assessment during long-term fluoxetine treatment. Am J Psychiatry. 1998 Sep;155(9):1247-53. doi: 10.1176/ajp.155.9.1247.
Background: PubMed 22193671Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
Background: PubMed 2963053Maier W, Buller R, Philipp M, Heuser I. The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord. 1988 Jan-Feb;14(1):61-8. doi: 10.1016/0165-0327(88)90072-9.
Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Background: PubMed 31441952Katz I, Barry CN, Cooper SA, Kasprow WJ, Hoff RA. Use of the Columbia-Suicide Severity Rating Scale (C-SSRS) in a large sample of Veterans receiving mental health services in the Veterans Health Administration. Suicide Life Threat Behav. 2020 Feb;50(1):111-121. doi: 10.1111/sltb.12584. Epub 2019 Aug 23.
Background: PubMed 26453453Hill KG, Woodward D, Woelfel T, Hawkins JD, Green S. Planning for Long-Term Follow-Up: Strategies Learned from Longitudinal Studies. Prev Sci. 2016 Oct;17(7):806-18. doi: 10.1007/s11121-015-0610-7.
American Psychological Association (2022), Healthcare Practitioner SurveyLink provided by the sponsor.
Driessen E, \& Hollon SD. (2010). Cognitive behavioral therapy for mood disorders: Efficacy, moderators and mediators. Psychiatric Clinics of North America, 33(3), 537-55.Link provided by the sponsor.
Guy W: Clinical Global Impression. ECDEU Assessment Manual for Psychopharmacology, revised National Institute of Mental Health, Rockville, MD. (1976)Link provided by the sponsor.
Hedeker, D. \& Gibbons, R.D. (2006). Longitudinal data analysis. Hoboken, NJ: John Wiley \& Sons, Inc.Link provided by the sponsor.
Hollander, M., Wolfe, D. A., \& Chicken, E. (2013). Nonparametric statistical methods (3rd ed., pp. xiii, 819 pages). Hoboken, NJ: John Wiley \& Sons, Inc.Link provided by the sponsor.
Pasquini, G and Keeter, S. (2022) At least four in ten U.S. adults have faced high levels of psychological distress during COVID-19 pandemic. Pew Research Center Reports December 12, 2022Link provided by the sponsor.
Individual participant dataSharing planned: Yes. This study will be conducted in accordance with the following publication and data sharing policies and regulations: Toivoa™ will share anonymized/de-identified clinical trial data and publish research outcomes in scientific journals, or present data at conferences. Considerations for ensuring confidentiality of these shared data are described in Section 10.1.2 and 10.1.3. We will implement a review process for clinical publications prior to submission for publication in journals or presentation at medical conferences. As Responsible Party, Toivoa™ will share information about this/these trial(s) via timely registration updates, and results reporting in ClinicalTrials.gov. The informed consent documents used for this/these trial(s) will include statements to inform participants that information about the trial will be posted in ClinicalTrials.gov.

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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.

Laura Randa contact

612-237-5896

lranda@toivoa.us

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Randa (612-237-5896, lranda@toivoa.us), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8 (time frame: From Baseline to end of treatment (8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07140497, which also lists 32 linked publications.

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 14 Sep 2026.