Reduction of Anxiety in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching - A Randomized Clinical Trial

Conditions

• Anxiety
• Hearing Disability
• Mobility Disability

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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 Mental Health Coaches

Study Details

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.

Key Dates

Start date

Aug 31, 2026

Status verified

Jun 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Toivoa-001 Digital CBT + NBHWC 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 mental health 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.
• Sham Comparator: General Health Education + Interactive Quizzes
  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.

Primary Outcome Measure

Change in Evaluator-Administered Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8. [ Time Frame: Change in evaluator-administered Hamilton Anxiety Rating Scale (HAM-A) between baseline and Week 8. ]

Central Contacts

• Laura Randa
  612-237-5896
  [email protected]

Locations (4)

Find similar trials in Dover, DE

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