SuicidalPhase 1NCT07440004
Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts
A Phase 1 study testing Healthy Minds Program in people with Suicidal, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal
- What is being tested?
- Healthy Minds Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 1 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to understand the study procedures
- not fluent in English
- being unable to verify their identity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53703
About this study
Official title: 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
Read the 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.
- Conditions
- Suicidal
- Being tested
- Healthy Minds Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Minds ProgramDevice
Also called HMP
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Minds Program | Experimental | Not described Receives: Device: Healthy Minds Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Post-Intervention (4 weeks)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Post-Intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start10 Apr 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicidalStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brooke Ammerman, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440004
- Sponsor's protocol ID
- 2025-1809
- Other IDs
- FA, UWMSN | L&S | Psychology, Protocol Version 5/8/2026
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Initial Feasibility and Acceptability Study of the Healthy Minds Program: A Digital Mindfulness-Based Intervention for Individuals Experiencing Suicidal Thoughts
- ClinicalTrials.gov ID
- NCT07440004
- Acronym / sponsor ID
- 2025-1809
- Conditions
- Suicidal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Minds Program | Experimental | Device: Healthy Minds Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18 or older
- past month history of active suicidal ideation
- English speaking
- primary owner of smartphone
- has regular access to the internet
Key exclusion criteria (3 listed)
- unable to understand the study procedures
- not fluent in English
- being unable to verify their identity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Minds ProgramAlso: HMPParticipants 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. | Device | Healthy Minds Program |
Primary outcome
Change in Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, Post-Intervention (4 weeks)
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.
4 secondary outcomes
Change in Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Baseline, Post-Intervention (4 weeks)
Change in Behavioral Approach System and Behavioral Inhibition System Scale (BIS/BAS)
Time frame: Baseline, Post-Intervention (4 weeks)
Change in Self-Compassion Scale - Short Form (SCS-SF)
Time frame: Baseline, Post-Intervention (4 weeks)
Change in PROMIS : Meaning and Purpose Subscale
Time frame: Baseline, Post-Intervention (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Suicidal
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
RecruitingObservational study
Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders
Self-harm Behavior, Eating Disorders
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooke Ammerman, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Healthy Minds Program in people with Suicidal, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Columbia Suicide Severity Rating Scale (C-SSRS) (time frame: Baseline, Post-Intervention (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.