Development of an Accessible Cognitive Behavioral Therapy Digital Therapeutic for Individuals With Long COVID

Toivoa Inc

Overview

This study will evaluate Toivoa-004 as an experimental digital therapeutic for persons with Long COVID suffering from anxiety or depression. This study will evaluate the completion rates of the Toivoa-004 program and survey the user's experience upon completion. Changes in anxiety and depression scores will be monitored during the study.

There is an urgent unmet need for digital mental health interventions specifically designed for individuals suffering from Long COVID. In this research, we will evaluate a new digital intervention program designed specifically for those experiencing persistent mental health symptoms such as anxiety, depression, trauma, or cognitive dysfunction following COVID-19 infection. The intervention (called Toivoa-004) was created to meet the accessibility and personalization needs of this population and to introduce and measure the clinical impact of a cognitive behavioral therapy intervention combined with mental health coaching, tailored to the unique challenges faced by Long COVID patients and their caregivers. Primary Objective: Assess the feasibility of participants remaining active users of the Toivoa-004 digital therapeutic over the 12-week study period. Active use will be described in terms of engagement with the platform's core modules as tracked by system analytics. Exploratory Objective: Explore the usability, ease of use, and acceptability of Toivoa-004 by evaluating engagement with core therapeutic components. Data include usage metrics, satisfaction ratings, and qualitative feedback through in-app surveys and interviews.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Conditions

Long Covid Depression Anxiety

Interventions

Rauha® Digital Therapeutic Platform (Toivoa-004)DEVICE

A coach-delivered, WCAG 2.2 AA-accessible digital therapeutic targeting anxiety and depression symptom management in adults with clinically documented Long COVID. The platform integrates evidence-based behavioral health content delivered via the Rauha® Coach application.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Presence of clinically diagnosed Long COVID. 3. Stated willingness to comply with all study procedures and lifestyle considerations, and availability for the duration of the study. 4. Males and females; Age 22 and above. 5. Clinical Diagnosis of Long COVID 6. Willingness to adhere to the study regiment. 7. Access to necessary resources for participating in a technology-based intervention (i.e., Phone, internet access). 8. Able to read and speak English fluently. 9. Resident of the US and living in the US for the duration of the study. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Exclusion Criteria: 1. Self-reported substance use disorder. In the past 12 months (not including tobacco). 2. Self-reported suicide attempts 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). 3. Currently pregnant or planning to become pregnant during the treatment period.

Outcomes

Primary Outcomes

Proportion of active users at Week 12

The primary endpoint is participant engagement with Toivoa-004, defined as the completion of at least 75% of the Toivoa-004 modules over the 12-week study period. Engagement will be measured via system analytics (module completions and usage logs). Feasibility will be considered achieved if more than 50% of enrolled participants meet this completion criterion.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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