Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477913
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
Exploratory Study for Toivoa-001 on Human Factors
Sponsor:
Toivoa Inc
Organization:
Toivoa Inc
Study Overview
Official Title:
Exploratory Study for Reduction of Anxiety and Depression Through Dual Mental Health Treatment Digital-Based Cognitive Behavioral Therapy and National Board Health and Wellness Coaches NBHWC For People With Disabilities
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Study will evaluate Rauha as an experimental digital therapeutic for persons with Disabilities suffering from anxiety andor depression The study will evaluate completion rates of the program and survey the users experience upon completion Changes in anxiety and depression scores will be monitored during the study
Detailed Description:
The Investigators propose a single-arm controlled trial evaluating Rauha plus usual care as an intervention for persons actively seeking treatment for anxiety andor depression Recruitment will occur at a single US health facility where approximately 30 adults with disabilities and clinically elevated anxiety andor depressive symptoms will be we will recruited and enrolled Eligible participants will be administered Rauha as a remote app with site oversight Patients will be monitored and encouraged by Mental Health Coaches to complete the therapy Mental Health Coaches will also provide instruction on completion of modules Patients will engage with the Rauha app have the opportunity to complete all 33 modules receive Mental Health Coach support and engage with the online community for a total of 8 weeks The community forum feature will provide patients access to a community forum that understands the specific struggles of the condition allowing users to interact with one another via an online community designed for empowerment and support Support from a Mental Health Coach will be provided at prescribed intervals and will also be available to each participant in addition to access to the online community A participant is considered to have completed the study if he or she has completed all assessments The end of the study is defined as completion of the 4 week follow-up assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None