Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts

NCT07440004 | Active Not Recruiting Phase 1 FDA Device

• 4 other identifiers: 2025-1809FAUWMSN | L&S | PsychologyProtocol Version 5/8/2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Suicidal

Outcome Measures

Primary Outcomes (1)

• Change in Columbia Suicide Severity Rating Scale (C-SSRS)

  The Columbia-Suicide Severity Rating Scale (C-SSRS) scores suicide risk based on 10 categories of suicidal ideation and behavior, with affirmative "Yes" answers indicating risk and determining the need for intervention. It assesses both severity (0-5, with 1 being least and 5 most severe) and behavior (6-10). A "Yes" to items 1-2 implies lower risk; 3 indicates moderate risk; and 4-6 indicate high risk.

  Baseline, Post-Intervention (4 weeks)

Secondary Outcomes (4)

• Change in Five Facet Mindfulness Questionnaire (FFMQ)

  Baseline, Post-Intervention (4 weeks)

• Change in Behavioral Approach System and Behavioral Inhibition System Scale (BIS/BAS)

  Baseline, Post-Intervention (4 weeks)

• Change in Self-Compassion Scale - Short Form (SCS-SF)

  Baseline, Post-Intervention (4 weeks)

• Change in PROMIS : Meaning and Purpose Subscale

  Baseline, Post-Intervention (4 weeks)

Study Arms (1)

Healthy Minds Program

EXPERIMENTAL

Device: Healthy Minds Program

Interventions

Healthy Minds Program DEVICE

Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.

Also known as: HMP

Healthy Minds Program

Eligibility Criteria

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

You may qualify if:

• age 18 or older
• past month history of active suicidal ideation
• English speaking
• primary owner of smartphone
• has regular access to the internet
• able to validate their identity with a valid form of legal ID (via driver's license, student ID, state-issued ID, etc.)
• able to understand the nature of the study, provide informed consent, and complete study procedures

You may not qualify if:

• unable to understand the study procedures
• not fluent in English
• being unable to verify their identity

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53703, United States

Location

Study Officials

• Brooke Ammerman, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): August 11, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)