Suicidal
Conditions
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
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.
Interventions
DEVICEHealthy 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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Columbia Suicide Severity Rating Scale (C-SSRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Five Facet Mindfulness Questionnaire (FFMQ) | Baseline, Post-Intervention (4 weeks) | 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. |
| Change in Behavioral Approach System and Behavioral Inhibition System Scale (BIS/BAS) | Baseline, Post-Intervention (4 weeks) | 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. |
| Change in Self-Compassion Scale - Short Form (SCS-SF) | Baseline, Post-Intervention (4 weeks) | 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. |
| Change in PROMIS : Meaning and Purpose Subscale | Baseline, Post-Intervention (4 weeks) | 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. |
Countries
United States
Contacts
CONTACTBrooke A Ammerman, PhD
Outcome results
None listed