Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts
ConditionSuicidal
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18 or older
past month history of active suicidal ideation
English speaking
primary owner of smartphone
Disqualifiers
unable to understand the study procedures
not fluent in English
being unable to verify their identity
Trial design
Design model
Single group
Treatments tested in this trial
Healthy Minds Program
DeviceParticipants 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Healthy Minds ProgramExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline, Post-Intervention (4 weeks)Secondary outcomes
1
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.
Time frame
Baseline, Post-Intervention (4 weeks)2
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.
Time frame
Baseline, Post-Intervention (4 weeks)3
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.
Time frame
Baseline, Post-Intervention (4 weeks)4
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.
Time frame
Baseline, Post-Intervention (4 weeks)Sponsors and contacts
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Source ClinicalTrials.gov