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Exploratory Study for Toivoa-001 on Human Factors

NCT06477913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-08-21

Study results available
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Summary

The Study will evaluate Rauha as an experimental digital therapeutic for persons with Disabilities suffering from anxiety and/or depression. The study will evaluate completion rates of the program and survey the user's experience upon completion. Changes in anxiety and depression scores will be monitored during the study.

Conditions

  • Anxiety Depression
  • Disability Physical

Interventions

DEVICE

Rauha

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

Sponsors & Collaborators

  • Family Endeavors, Inc DBA Endeavors

    collaborator UNKNOWN

  • Advarra

    collaborator INDUSTRY

  • Toivoa Inc

    lead INDUSTRY

Principal Investigators

  • Jill Palmer · Collaborator

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2024-12-27
Completion
2025-01-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06477913 on ClinicalTrials.gov