Anxiety, Hearing Disability, Mobility Disability
Conditions
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
Brief summary
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.
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.
Interventions
DEVICESham 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.
DEVICEToivoa-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
Sponsors
Toivoa Inc
Delaware State University
VA New Jersey Health Care System
South Texas Veterans Health Care System
Louis Stokes VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The randomization allocation of UC+Toivoa-001 versus UC+Sham will be done in random blocks of 2, 4, 6, and 8 subjects. As the study progresses, the blocking will be reduced to 2 and 4. This will provide relative balance over the course of the study while minimizing study personnel ability to predict the next randomization assignment. Monthly balance of randomization assignments will be reported, although the randomization assignments will be coded as A versus B to maintain blinding. Each site will randomize independently from other sites & maintain its own randomization schedule. The study will be conducted as a double-blind study where both the participant & evaluators will not be aware of which study arm they have been assigned. Blinding assignments and onboarding instructions will be generated by the Site Administrator for a particular location. Blinding assignments will be made per site using procedures outside of the Rauha data platform and visible only to the Site Administrator.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 12 | From Baseline to 4 weeks after treatment (12 weeks) | 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. |
| Clinical Global Impression for Improvement (CGI-I) at Week 8 | From Baseline to end of treatment (8 weeks) | 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. |
| Clinical Global Impression for Improvement (CGI-I) at Week 12 | From Baseline to 4 weeks after treatment (12 weeks) | 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. |
| Proportion of participants achieving clinically meaningful response on Hamilton Anxiety Rating Scale (HAM-A) at Week 8 | From Baseline to end of treatment (8 weeks) | 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. |
Countries
United States
Contacts
CONTACTLaura Randa
Outcome results
None listed