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

NCT07714889 | Withdrawn FDA Device

• 2 other identifiers: 000892101R43NR021082-01A1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Long Covid; Depression; Anxiety

Keywords

Long COVID; Depression; Anxiety; Cognitive Behavioral Therapy; Digital Therapeutics; NBHWC; Health and Wellness Coaching

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Other Outcomes (3)

• User Acceptability

  12 weeks

• System Usability

  12 weeks

• User Experience

  12 weeks

Study Arms (1)

Toivoa-004

EXPERIMENTAL

Device: Rauha® Digital Therapeutic Platform (Toivoa-004)

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.

Toivoa-004

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Presence of clinically diagnosed Long COVID.
• Stated willingness to comply with all study procedures and lifestyle considerations, and availability for the duration of the study.
• Males and females; Age 22 and above.
• Clinical Diagnosis of Long COVID
• Willingness to adhere to the study regiment.
• Access to necessary resources for participating in a technology-based intervention (i.e., Phone, internet access).
• Able to read and speak English fluently.
• Resident of the US and living in the US for the duration of the study.
• \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

You may not qualify if:

• Self-reported substance use disorder. In the past 12 months (not including tobacco).
• 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).
• Currently pregnant or planning to become pregnant during the treatment period.

Sponsors & Collaborators

• Toivoa Inc: lead
• National Institute of Nursing Research (NINR): collaborator

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 20, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share