Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts

An Initial Feasibility and Acceptability Study of the Healthy Minds Program: A Digital Mindfulness-Based Intervention for Individuals Experiencing Suicidal Thoughts

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

Study Overview

• Status: Recruiting
• Conditions: Suicidal
• Intervention / Treatment: Device: Healthy Minds Program

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 2 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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Brooke A Ammerman, PhD; Phone Number: 7015522948; Email: baammerman@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53703
      • Recruiting
      • University of Wisconsin - Madison
      • Contact: Elizabeth Rose; Phone Number: 608-265-5504; Email: erose3@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy Minds Program

Device: Healthy Minds Program; 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.; Other Names: HMP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Five Facet Mindfulness Questionnaire (FFMQ)	The FFMQ is a 39-item self-report tool measuring mindfulness across five facets: Observing, Describing, Acting with Awareness, Non-judging, and Non-reactivity. Items are rated 1 (never true) to 5 (always true), with specific items reversed. Scores range from 39-195, where higher scores indicate greater, more developed trait mindfulness.	Baseline, Post-Intervention (4 weeks)
Change in Behavioral Approach System and Behavioral Inhibition System Scale (BIS/BAS)	The BIS/BAS scale is a 24-item self-report instrument assessing sensitivity to punishment/novelty (BIS) and rewards (BAS). It measures behavioral inhibition (7 items) and three BAS subfactors: Drive (4), Fun-Seeking (4), and Reward Responsiveness (5), using a 4-point Likert scale (1=Strongly Disagree, 4=Strongly Agree). Scores range from 24-96, where higher scores indicate greater sensitivity in that system.	Baseline, Post-Intervention (4 weeks)
Change in Self-Compassion Scale - Short Form (SCS-SF)	The SCS-SF is a 12-item questionnaire assessing how people treat themselves during difficult times, using a 5-point Likert scale (1=Almost Never to 5=Almost Always). Total scores are calculated by reversing negative items (1, 4, 8, 9, 11, 12) and finding the mean, with higher scores indicating greater self-compassion.	Baseline, Post-Intervention (4 weeks)
Change in PROMIS : Meaning and Purpose Subscale	The PROMIS Meaning and Purpose subscale is a 37-item questionnaire which measures an individual's sense of life purpose, hopefulness, and goal-directedness. Scores range from 20-80, where higher scores indicate greater, more positive, and more meaningful life purpose.	Baseline, Post-Intervention (4 weeks)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Brooke Ammerman, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-1809; FA (Other Identifier: UW Madison); UWMSN | L&S | Psychology (Other Identifier: UW Madison); Protocol Version 5/8/2026 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No