Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT07170202
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Increasing Mindfulness Engagement Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study is a pilot micro-randomized trial where participants are micro-randomized daily in a 28-day trial to receive different types of messages (episodic-future thinking, reciprocity, or no text message) and enticed by a gaming app to examine the feasibility and acceptability of these strategies to engage participants in a mindfulness mobile health application.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-09-05', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mobile Health Engagement', 'timeFrame': '1 month', 'description': 'We will assess engagement in our mindfulness mobile health application by measuring paradata (i.e., time spent in the app, whether or not the app was opened, which content was viewed in the app).'}], 'secondaryOutcomes': [{'measure': 'Change in Alcohol Use', 'timeFrame': 'Baseline; 1 month; 3 months', 'description': 'Participants will utilize recall and report the total number of days they consumed alcohol over the last 30 day period'}, {'measure': 'Change in Stress', 'timeFrame': 'Baseline; 1 month; 3 months', 'description': 'Perceived Stress Scale is a 10 question Likert Scale that utilizes a 0-4 range ( 0=no stress and 4=the worst stress ever). With Score Ranges possible from 0-40 that assess the participants perceived stress over the last 30days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants', 'Feasibility Studies', 'Acceptability']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine the feasibility and acceptability of different types of text messages and a integrated gaming app to increase engagement in a mindfulness mobile health application.\n\n1. Does receiving text messages increase engagement in a mindfulness app?\n2. Does an integrated gaming app increase engagement in a mindfulness app?\n\nResearchers will examine whether participants engage more in a mindfulness mobile health application if they receive text messages and if they engage in additional gaming app on their smartphone. Participants will:\n\n1. Use a mindfulness and gaming mobile health application for 28-days.\n2. Complete a pre-study survey, post-study survey, follow-up interview, and 3-month follow-up survey in addition to daily brief surveys.', 'detailedDescription': 'Participants who are eligible to participate in the pilot micro-randomized trial (MRT) will be screened and onboarded via Zoom. They will be given baseline measures and trained on using the mindfulness app with integrated gaming app on their smartphone. Micro-randomizations will be used to address scientific questions related to the delivery and personalization of episodic future thinking and reciprocity engagement strategies in addition to gamification across the 28-day trial. The proposed pilot MRT will micro-randomize participants in the morning into one of three options: (i) episodic future thinking text-based prompts, (ii) reciprocity text-based prompts, or (iii) no prompts with equal probability. Participants will receive mobile-based ecological momentary assessments in the evening. EMA data will be paired with usage data from the mindfulness app (e.g., time spent in app, number of sessions, completion of mindfulness videos) to assess the conditions under which participants are receptive to engagement strategies. After 28 days, a follow-up survey questionnaire will be administered and an individual interview will be conducted with each participant. A 3-month follow-up survey will also be administered to participants who complete the study. Our primary outcome in engagement in the mindfulness app, and our secondary outcomes are stress and alcohol use.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* US-born\n* Black\n* biological man\n* undergraduate college student\n* criteria for binge drinking (5 drinks in about 2 hours) or heavy drinking (more than 14 drinks per week).'}, 'identificationModule': {'nctId': 'NCT07170202', 'acronym': 'TIMEProject', 'briefTitle': 'The Increasing Mindfulness Engagement Project', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Translating Behavioral Economics Strategies to Culturally Tailor a Mobile Health Mindfulness Intervention to Reduce Risky Drinking Behaviors in Black College Student Men', 'orgStudyIdInfo': {'id': 'STUDY00004768'}, 'secondaryIdInfos': [{'id': '5K23AA030602', 'link': 'https://reporter.nih.gov/quickSearch/5K23AA030602', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Reciprocity', 'description': 'Reciprocity text messages include giving participants a message with an solicited reward (e.g., credits in gaming app, $1).', 'interventionNames': ['Other: Mindfulness Smartphone Application']}, {'type': 'OTHER', 'label': 'Episodic Future Thinking', 'description': 'Episodic Future Thinking text messages include giving participants a message that encourages them to think vividly about their future', 'interventionNames': ['Other: Mindfulness Smartphone Application']}, {'type': 'OTHER', 'label': 'No text message', 'description': 'Participants receive no text message in this arm', 'interventionNames': ['Other: Mindfulness Smartphone Application']}], 'interventions': [{'name': 'Mindfulness Smartphone Application', 'type': 'OTHER', 'description': 'A mindfulness mobile health smartphone application that has mindfulness information and practice videos.', 'armGroupLabels': ['Episodic Future Thinking', 'No text message', 'Reciprocity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32305', 'city': 'Tallahassee', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Reid Marks, PhD', 'role': 'CONTACT', 'email': 'laura.reidmarks@med.fsu.edu'}], 'facility': 'Florida State University Center for Translational Behavioral Science', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}], 'centralContacts': [{'name': 'Laura Reid Marks, PhD', 'role': 'CONTACT', 'email': 'laura.reidmarks@med.fsu.edu', 'phone': '(850)644-2334'}, {'name': 'FSU CTBS', 'role': 'CONTACT', 'email': 'ctbscience@med.fsu.edu', 'phone': '850-644-2234'}], 'overallOfficials': [{'name': 'Laura Reid Marks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Laura Marks', 'investigatorAffiliation': 'Florida State University'}}}}