Not_yet_recruitingNANCT07140497

Reduction of Anxiety Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy (CBT) and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches for People With Disabilities (RADD)

Sponsor: Toivoa Inc

Trial Details

ConditionHearing Disability, Anxiety, Mobility Disability
InterventionSham 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.
PhaseNA
StatusNot_yet_recruiting
Participants200
Est. Completion1 Mar 2027
Last Updated20 July 2026

Primary Outcome

Change in Evaluator-Administered Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 8.

Eligibility Criteria

Inclusion Criteria

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

Trial Sites

Countries

United States
View Registry Entry

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