Hearing DisabilityNCT07195292
Reduction of Depression Through Dual Treatment: Digital CBT & NBHWC Coaching
A study testing Toivoa-002 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching. in people with Hearing Disability and Depression, run by Toivoa Inc at 4 sites in United States.
Trial summary
The purpose of this study is to see if a mobile-delivered mental health program called Toivoa-002, which combines digital cognitive behavioral therapy (CBT) with personal coaching, can effectively reduce depression in adults with hearing or mobility disabilities. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hearing Disability, Depression, Mobility Disability
- What is being tested?
- Toivoa-002 - 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
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
- Male or female, age 22 years or older
- A score of 17 or higher on the HAM-D
- Clinical diagnosis of depression based on DSM-5 diagnostic criteria
Show all 11Show fewer
- Willingness to adhere to the Toivoa-002 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.
United States4 sites
Louis Stokes Cleveland VAMC
Cleveland, Ohio, 44016
Mary Ann 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, gscottjones@desu.edu
New Jersey Department of Veterans Health
East Orange, New Jersey, 07018
Monica Clement, PhD, 973-676-1000 ext. 201645, monica.clement@va.gov
Monica Clement, PhD
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
About this study
Official title: Reduction of Depression 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-002, which combines digital cognitive behavioral therapy (CBT) with personal coaching, can effectively reduce depression in adults with hearing or mobility disabilities. The study aims to answer whether this dual-intervention digital service is more effective at lowering depression 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-002 program will show significantly greater reductions in depression 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 depression. By offering a fully remote and accessible mobile tool, this study seeks to determine if a digital health service can deliver scalable, effective depression 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-002, a mobile-delivered cognitive behavioral therapy (CBT) program tailored for people with disabilities, combined with National Board for Health and Wellness Coaching (NBHWC)-certified coaching, in reducing depression 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 depression, and common co-morbidities. Depression 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 Depression Rating Scale (HAM-D) 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 anxiety (HAM-A) and self-reported depression (PHQ-9) 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 coaching, for depression reduction in people with disabilities, with potential implications for scalable, accessible mental health care delivery.
- Conditions
- Hearing Disability, Depression, Mobility Disability
- Being tested
- Sham Digital Program - General health education and interactive quizzes unrelated to depression or CBT., Toivoa-002 - A digital Cognitive Behavioral Therapy program combined with NBHWC-certified coaching.
- Keywords
- Depression, 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
- Depression
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 depression or CBT.Device
General health and wellness information with interactive quizzes. This content is not related to depression treatment or CBT techniques.
Toivoa-002 - 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 group | Role | What they receive |
|---|---|---|
| Toivoa-002 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-002 (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-002 - 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 depression 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 depression or CBT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale (HAM-D) from Baseline to Week 8
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. Analyses will use a mixed model for repeated measures (MMRM) in the Intent-to-Treat (ITT) population including 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-D as a covariate. Within-participant correlation across repeated measurements will be modeled using a 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 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 Depression Rating Scale (HAM-D) from Baseline to Week 12
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. Change from Baseline Assessment to Week 12 in HAM-D 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-D 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 Depression Rating Scale (HAM-D) at Week 8
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. HAM-D response at Week 8, defined as a reduction of at least 4 points from Baseline Assessments in HAM-D 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.
- First posted26 Sep 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 (34)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)
Sponsor and investigators
- Lead sponsor
- Toivoa Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Delaware State University, VA New Jersey Health Care System, Louis Stokes VA Medical Center, South Texas Veterans Health Care System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195292
- Sponsor's protocol ID
- 00084427
- Status last verified
- Jul 2026
- First submitted
- 7 Sep 2025
- Last updated
- 10 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
Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288-95. doi: 10.1002/wps.20151.
PubMed 25273302Chen LH, Lee WC. Two-way minimization: a novel treatment allocation method for small trials. PLoS One. 2011;6(12):e28604. doi: 10.1371/journal.pone.0028604. Epub 2011 Dec 7.
PubMed 22163317DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, O'Reardon JP, Lovett ML, Gladis MM, Brown LL, Gallop R. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry. 2005 Apr;62(4):409-16. doi: 10.1001/archpsyc.62.4.409.
PubMed 15809408Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006 Aug;74(4):658-70. doi: 10.1037/0022-006X.74.4.658.
PubMed 16881773Gallop R, Tasca GA. Multilevel modeling of longitudinal data for psychotherapy researchers: II. The complexities. Psychother Res. 2009 Jul;19(4-5):438-52. doi: 10.1080/10503300902849475.
PubMed 20183399Gibbons 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 8357299Gottfredson 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 24274626Han 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 19739238Hill 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 26453453Katz 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 31441952Kroenke 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 11556941Maier 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 2963053Posner 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 22193671Reimherr 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 9734550Rush AJ, South C, Jain S, Agha R, Zhang M, Shrestha S, Khan Z, Hassan M, Trivedi MH. Clinically Significant Changes in the 17- and 6-Item Hamilton Rating Scales for Depression: A STAR*D Report. Neuropsychiatr Dis Treat. 2021 Jul 14;17:2333-2345. doi: 10.2147/NDT.S305331. eCollection 2021.
PubMed 34295161