[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576779":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":57,"studyPopulation":51,"armGroups":58,"interventions":71,"overallOfficials":79,"centralContacts":83,"locations":88,"responsibleParty":107,"collaborators":109,"id":112,"slug":51,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":51,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":51,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":51,"overallStatus":90,"whyStopped":51,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"University of South Dakota","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Intention to Persist in College","Change in participants' intention to persist in college will be assessed through an individual item rated in a numeric rating scale. Scores range from 0 to 5 with higher scores reflecting greater intent to remain in college.","Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Anxiety","Symptoms will be assessed through a state anxiety assessment. Scores range from 0-60 with higher scores indicating higher levels of anxiety.","Changes in participant's state anxiety will be captured within 5-minutes prior to each intervention and within 5 minutes after each intervention (mindfulness and psychoeducation)",{"measure":19,"description":20,"timeFrame":17},"Depression","Symptoms will be assessed through a state depression assessment. Scores range from 0-20 with higher scores indicating higher levels of depression.",[22,26,30,33,36,39,42],{"measure":23,"description":24,"timeFrame":25},"Adverse Childhood Experiences questionnaire","Participants adverse childhood experiences will be assessed at baseline to explore how childhood adversities moderate outcomes.The ACEs questionnaire was adapted from the Felitti et al., (1998) wave two survey and current questions used by the CDC's telephone Behavioral Risk Factor Surveillance System survey collected in all 50 states. ACES range between 0-13 and the higher the score, the higher the number of ACES.","Baseline",{"measure":27,"description":28,"timeFrame":29},"Sensation Manikin","Change in the distribution of pleasant and unpleasant bodily sensations. Scores can range from 0-100 for pleasant (higher scores indicate higher pleasant feelings) and 0-100 for unpleasant feelings (higher scores indicate higher levels of unpleasant sensations).","Changes in participant's state body sensations will be captured within 5-minutes prior to each intervention and within 5 minutes after each intervention (mindfulness, external qigong, and psychoeducation)",{"measure":31,"description":32,"timeFrame":12},"Perceived Discrimination","Changes in the perception of experiencing discrimination (Everyday Discrimination). Scores range from 0 -54 with higher scores indicating higher levels of discrimination.",{"measure":34,"description":35,"timeFrame":12},"Connectedness to Nature Questionnaire","The effects on Connectedness to Nature as a moderator between treatment and outcomes. The scale consists of 16 items rated on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree) and is scored by creating a mean of the 16 items, with scores ranging from one to five, with higher scores indicating a stronger connectedness to nature than lower scores.",{"measure":37,"description":38,"timeFrame":12},"Dispositional Mindfulness Scale","The Metacognitive Processes of Decentering scale (MPoD-t) will be used to assess the effects of dispositional mindfulness as a moderator between treatment and outcomes. Scores range from 0-80 with higher scores indicating higher dispositional mindfulness.",{"measure":40,"description":41,"timeFrame":12},"Sense of Belonging in College","The role of treatment type on the participant's sense of belonging in college. Scores range from 0-56 with higher scores indicating higher levels of belonging.",{"measure":43,"description":44,"timeFrame":45},"Trait Self-Transcendence","Change in self-transcendent state will be measured with the Nondual Awareness Dimensional Assessment - State Version. Scores range from 0 to 10, with higher scores reflecting greater self-transcendence.","Changes in participant's self-transcendence will be captured within 5-minutes prior to each intervention and within 5 minutes after each intervention (mindfulness, external qigong, and psychoeducation)",{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":51,"timePerspective":51,"maskingInfo":52},"RANDOMIZED","PARALLEL","Participants will be randomized to receive either: 1) Mindfulness Meditation or 2) Psychoeducation","TREATMENT",null,{"masking":53,"maskingDescription":54,"whoMasked":55},"SINGLE","The PI will randomly assign participants to condition and coordinate treatment group scheduling; the assessor will be blinded to condition.",[56],"OUTCOMES_ASSESSOR","Method\u002FDesign. This study will be a remote, two-arm, randomized, controlled trial. First-generation college students (N=53) will be randomized to either mindfulness meditation (MM), or psychoeducation (PE). The mindfulness meditation will be a loving kindness meditation adapted to apply to college communities. Each intervention will be applied for 30 minutes, once a week, for four weeks through a remote platform. The MM is adapted through a validated brief mindfulness-based intervention framework (Zeidan, 2010). The primary outcome, intention to persist in college, and the secondary outcomes, depression and anxiety, will be assessed by a blinded researcher at baseline, one-week post treatment, and one-month follow-up. Change in sense of connection during the final treatment session, measured with a comprehensive battery of self-report indices, will be the primary therapeutic mechanism.\n\nAims and Objectives. The proposed project's central hypothesis is that MM will increase first-generation students' intention to persist in college and increase their emotional well-being by increasing their sense of belonging in their college community. Aim 1. Examine MM's effect on first-generation college students' intention to persist in college (primary outcome) over time. Hypothesis: Participants who are randomized into the MM group will report higher intention to persist scores from baseline to one-month follow-up than those who are randomized to PE. Aim 2.\n\nExploratory. Determine MM's effect on anxiety and depression scores (co-secondary outcomes) over time. Hypothesis: MM will decrease depression and anxiety relative to PE from baseline to one-month follow-up. Aim 3: Exploratory. Investigate whether transcendent states during the final MM session predicts students' intention to persist scores. Hypothesis: The effect of MM on students' intention to persist will be mediated by self-transcendent experience during mindfulness practice.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Mindfulness Meditation","EXPERIMENTAL","Participants will meet virtually with the mindfulness practitioner once a week for four weeks for 30-minute segments.",[64],"Behavioral: Mindfulness Meditation",{"label":66,"type":67,"description":68,"interventionNames":69},"Psychoeducation","ACTIVE_COMPARATOR","Participants will receive recordings online, once a week for four weeks which will be approximately 30 minutes in length.",[70],"Other: Psychoeducation",[72,76],{"type":73,"name":60,"description":74,"armGroupLabels":75,"otherNames":51},"BEHAVIORAL","Mindfulness meditation will be facilitated by a seasoned mindfulness practitioner. Participants will be guided through a loving kindness meditation adapted to apply to college communities and designed to help increase a sense of interconnectedness among their college community. They will also learn how to deconstruct feelings of anxiety and\u002For depression into sensory, emotional, cognitive, and behavioral components.",[60],{"type":6,"name":66,"description":77,"armGroupLabels":78,"otherNames":51},"In the psychoeducation arm, participants will receive information related to creating connections with campus community and managing anxiety and\u002For depression through a presentation. They will also receive information on resources for connecting with their community and treating anxiety and\u002For depression.",[66],[80],{"name":81,"affiliation":5,"role":82},"Natalie Lecy","PRINCIPAL_INVESTIGATOR",[84],{"name":81,"role":85,"phone":86,"phoneExt":51,"email":87},"CONTACT","6058644151","natalie.lecy@usd.edu",[89],{"facility":5,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"RECRUITING","Sioux Falls","South Dakota","57107","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-96.72796,43.54369,{"lat":100,"lon":99},[103,106],{"name":104,"role":85,"phone":105,"phoneExt":51,"email":87},"Natalie Lecy, PhD","8019103165",{"name":104,"role":82,"phone":51,"phoneExt":51,"email":51},{"type":108,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR",[110],{"name":111,"class":6},"Mind and Life Institute, Hadley, Massachusetts","100576779",false,"NCT06789731","Mindfulness-Based Interventions Targeting First-Generation College Student Retention in Rural Environments","Inclusion Criteria:\n\n18 years or older. Currently enrolled in four-year college in the United States. First-generation college student. Access to WiFi and a computer\u002Fsmartphone\u002Ftablet. English speaking.\n\nExclusion Criteria:\n\nNot currently enrolled in a four-year college. Not a first-generation college student. Non-English speaker. Not able to utilize WiFi or computer\u002Ftablet\u002Fsmartphone.",true,"ALL","18 Years","64 Years",{"count":122,"type":123},53,"ESTIMATED","INTERVENTIONAL",[126],"NA","The goal of this randomized control group is to learn about effective treatments for college students experiencing anxiety and\u002For depression. The main questions this clinical trial aims to answer are: 1) Can mindfulness-based treatments increase retention rates among first-generation college students? 1) Can mindfulness-based treatments decrease anxiety and\u002For depression among first-generation college students?\n\nParticipants will be randomly assigned to one of two intervention groups: mindfulness meditation or psychoeducation. Researchers will compare outcomes from each group to explore treatment differences.",[19,15],"2026-01-26",{"date":131,"type":132},"2026-01-28","ACTUAL",{"date":134,"type":132},"2025-01-01",{"date":136,"type":123},"2027-06",{"name":5,"class":6},1]