Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:16 AM
Study NCT ID:
NCT07440004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline, Post-Intervention (4 weeks)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Five Facet Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'Baseline, Post-Intervention (4 weeks)', 'description': '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.'}, {'measure': 'Change in Behavioral Approach System and Behavioral Inhibition System Scale (BIS/BAS)', 'timeFrame': 'Baseline, Post-Intervention (4 weeks)', 'description': '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.'}, {'measure': 'Change in Self-Compassion Scale - Short Form (SCS-SF)', 'timeFrame': 'Baseline, Post-Intervention (4 weeks)', 'description': '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.'}, {'measure': 'Change in PROMIS : Meaning and Purpose Subscale', 'timeFrame': 'Baseline, Post-Intervention (4 weeks)', 'description': "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."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Suicidal']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants will:\n\n* complete questionnaires\n* use HMP app for 4 weeks', 'detailedDescription': '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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 18 or older\n* past month history of active suicidal ideation\n* English speaking\n* primary owner of smartphone\n* has regular access to the internet\n* able to validate their identity with a valid form of legal ID (via driver's license, student ID, state-issued ID, etc.)\n* able to understand the nature of the study, provide informed consent, and complete study procedures\n\nExclusion Criteria:\n\n* unable to understand the study procedures\n* not fluent in English\n* being unable to verify their identity"}, 'identificationModule': {'nctId': 'NCT07440004', 'briefTitle': 'Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'An Initial Feasibility and Acceptability Study of the Healthy Minds Program: A Digital Mindfulness-Based Intervention for Individuals Experiencing Suicidal Thoughts', 'orgStudyIdInfo': {'id': '2025-1809'}, 'secondaryIdInfos': [{'id': 'FA', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'UWMSN | L&S | Psychology', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 12/8/2025', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Minds Program', 'interventionNames': ['Device: Healthy Minds Program']}], 'interventions': [{'name': 'Healthy Minds Program', 'type': 'DEVICE', 'otherNames': ['HMP'], 'description': '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.', 'armGroupLabels': ['Healthy Minds Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53703', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Rose', 'role': 'CONTACT', 'email': 'erose3@wisc.edu', 'phone': '(608) 265-5504'}], 'facility': 'University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Brooke A Ammerman, PhD', 'role': 'CONTACT', 'email': 'baammerman@wisc.edu', 'phone': '7015522948'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}