Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:16 AM
Study NCT ID:
NCT07440004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
An Initial Feasibility and Acceptability Study of the Healthy Minds Program: A Digital Mindfulness-Based Intervention for Individuals Experiencing Suicidal Thoughts
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
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 purpose of this clinical trial is to see whether the Healthy Minds Program (HMP) is practical to use, well-received, and shows early signs of helping people who have recently experienced suicidal thoughts or behaviors.
Participants will:
* complete questionnaires
* use HMP app for 4 weeks
Participants will:
* complete questionnaires
* use HMP app for 4 weeks
Detailed Description:
This study tests whether the Healthy Minds Program (HMP)-a free, self-guided mindfulness and well-being smartphone app-can be used safely and comfortably by adults who have had suicidal thoughts recently. Adults ages 18-65 who have had active suicidal thoughts in the past month will take part for about 4 weeks (about one month total). Everyone in the study will use the app; there is no comparison group.
After a brief eligibility screen, participants complete a baseline video visit (about 1.5 hours) that includes questionnaires and an interview about mood and well-being, a structured interview about suicidal thoughts and behaviors, and creating an individualized safety plan. During the 4-week period, participants use short lessons and guided practices in the app (5-30 minutes; sitting or active) across four skill areas: awareness, connection, insight, and purpose. Participants also complete brief weekly surveys during the 4 weeks, and a post-intervention video visit (about 1 hour) that repeats key interview and questionnaire measures and asks about how usable/helpful the app felt.
After a brief eligibility screen, participants complete a baseline video visit (about 1.5 hours) that includes questionnaires and an interview about mood and well-being, a structured interview about suicidal thoughts and behaviors, and creating an individualized safety plan. During the 4-week period, participants use short lessons and guided practices in the app (5-30 minutes; sitting or active) across four skill areas: awareness, connection, insight, and purpose. Participants also complete brief weekly surveys during the 4 weeks, and a post-intervention video visit (about 1 hour) that repeats key interview and questionnaire measures and asks about how usable/helpful the app felt.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: