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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (4)