Exploratory Study for Toivoa-001 on Human Factors

NCT06477913 | Completed FDA Device

• 1 other identifier: TDX01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Digital Therapeutics

Outcome Measures

Primary Outcomes (1)

• Therapy dropout rates as a percentage of enrolled participants

  Assess the proportion of the Intent to Treat population who remain active users of the program at the end of the 8-week primary study period. Dropout rates will be reported as the percentage of enrolled users who continue to engage with the digital therapy per week.

  8 weeks

Secondary Outcomes (4)

• Changes in numeric GAD-7 Assessment scores following therapy.

  8 weeks

• Changes in numeric PHQ-9 Assessment scores following therapy.

  8 weeks

• Changes of numeric GAD-7 Assessment scores from completion through 4-weeks post therapy.

  12 weeks

• Changes of numeric PHQ-9 Assessment scores from completion through 4-weeks post therapy.

  12 weeks

Other Outcomes (3)

• User Experience Survey

  8 weeks

• User Acceptability Survey

  8 weeks

• System Usability Survey

  8 weeks

Study Arms (1)

Active Rauha Therapy

EXPERIMENTAL

Qualified intend to treat (ITT) population evaluating Rauha and access to Mental Health Coaches

Device: Rauha

Interventions

Rauha 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

Also known as: Toivoa-001

Active Rauha Therapy

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 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 and above.
• Score of 10 or greater on the Patient Health Questionnaire-9 (PHQ-9) or Generalized Anxiety Disorder-7 (GAD-7) (to be assessed post-study-specific screening consent).
• Willingness to adhere to the study regiment.
• Access to necessary resources for participating in a technology-based intervention (i.e., iPhone, internet access).
• Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days before study entry).
• Able to read and speak English fluently.
• Resident of the US and living in the US for the duration of the trial. -

You may not qualify if:

• 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 (not including 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 or planning to become pregnant during the treatment period. -

Sponsors & Collaborators

• Toivoa Inc: lead
• Family Endeavors, Inc DBA Endeavors: collaborator
• Advarra: collaborator

Study Sites (1)

The Steven A. Cohen Military Family Clinic at Endeavors

San Antonio, Texas, 78249, United States

Location

Study Officials

• Jill Palmer

  Collaborator

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: July 11, 2024
• Primary Completion: December 27, 2024
• Study Completion: January 9, 2025
• Last Updated: May 14, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)