[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06789731":3,"trial-entities:NCT06789731":106,"trial-summary:NCT06789731":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":43,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":57,"locations":59,"central_contacts":76,"overall_officials":80,"references":82,"see_also_links":105},"NCT06789731","23-117","Mindfulness-Based Interventions Targeting First-Generation College Student Retention in Rural Environments","RECRUITING","2027-06","2026-01","2026-01-28","2025-01-01","University of South Dakota","OTHER",false,"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.","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.",[18,19],"Depression","Anxiety",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},53,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Mindfulness Meditation","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.",[31],{"type":13,"name":35,"description":36,"armGroupLabels":37},"Psychoeducation","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.",[35],[39],{"measure":40,"description":41,"timeFrame":42},"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)",[44,47],{"measure":19,"description":45,"timeFrame":46},"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":18,"description":48,"timeFrame":46},"Symptoms will be assessed through a state depression assessment. Scores range from 0-20 with higher scores indicating higher levels of depression.","ALL","18 Years","64 Years",true,{"inclusion":54,"exclusion":55,"raw_text":56},[],[],"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.",[58],"ADULT",[60],{"facility":12,"status":7,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":73},"Sioux Falls","South Dakota","57107","United States",[66,71],{"name":67,"role":68,"phone":69,"email":70},"Natalie Lecy, PhD","CONTACT","8019103165","natalie.lecy@usd.edu",{"name":67,"role":72},"PRINCIPAL_INVESTIGATOR",{"lat":74,"lon":75},43.54369,-96.72796,[77],{"name":78,"role":68,"phone":79,"email":70},"Natalie Lecy","6058644151",[81],{"name":78,"affiliation":12,"role":72},[83,87,90,93,96,99,102],{"pmid":84,"type":85,"citation":86},"11597055","BACKGROUND","Steer RA, Brown GK, Beck AT, Sanderson WC. Mean Beck Depression Inventory-II scores by severity of major depressive episode. Psychol Rep. 2001 Jun;88(3 Pt 2):1075-6. doi: 10.2466\u002Fpr0.2001.88.3c.1075.",{"pmid":88,"type":85,"citation":89},"31246748","Hanley AW, Garland EL. Mapping the Affective Dimension of Embodiment With the Sensation Manikin: Validation Among Chronic Pain Patients and Modification by Mindfulness-Oriented Recovery Enhancement. Psychosom Med. 2019 Sep;81(7):612-621. doi: 10.1097\u002FPSY.0000000000000725.",{"pmid":91,"type":85,"citation":92},"30058824","Hanley AW, Nakamura Y, Garland EL. The Nondual Awareness Dimensional Assessment (NADA): New tools to assess nondual traits and states of consciousness occurring within and beyond the context of meditation. Psychol Assess. 2018 Dec;30(12):1625-1639. doi: 10.1037\u002Fpas0000615. Epub 2018 Jul 30.",{"pmid":94,"type":85,"citation":95},"33091745","Knowles KA, Olatunji BO. Specificity of trait anxiety in anxiety and depression: Meta-analysis of the State-Trait Anxiety Inventory. Clin Psychol Rev. 2020 Dec;82:101928. doi: 10.1016\u002Fj.cpr.2020.101928. Epub 2020 Oct 10.",{"pmid":97,"type":85,"citation":98},"19341164","Sims M, Wyatt SB, Gutierrez ML, Taylor HA, Williams DR. Development and psychometric testing of a multidimensional instrument of perceived discrimination among African Americans in the Jackson Heart Study. Ethn Dis. 2009 Winter;19(1):56-64.",{"pmid":100,"type":85,"citation":101},"9635069","Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016\u002Fs0749-3797(98)00017-8.",{"pmid":103,"type":85,"citation":104},"29312052","Navarro O, Olivos P, Fleury-Bahi G. \"Connectedness to Nature Scale\": Validity and Reliability in the French Context. Front Psychol. 2017 Dec 12;8:2180. doi: 10.3389\u002Ffpsyg.2017.02180. eCollection 2017.",[],{"nct_id":4,"conditions":107,"biomarkers":108},[19,18],[],{"nct_id":4,"found":52,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is a remote, randomized controlled trial involving 53 first-generation college students. Participants will be randomly assigned to one of two groups: mindfulness meditation or psychoeducation.","completed","Mindfulness for First-Generation College Students with Anxiety\u002FDepression","This study is looking at how mindfulness meditation and psychoeducation can help first-generation college students dealing with anxiety and\u002For depression. Researchers want to see if these approaches can help students stay in college and improve their well-being. You would be randomly assigned to either the Mindfulness Meditation group, where you'll learn a special type of meditation, or the Psychoeducation group, which provides information on connecting with your campus community and managing anxiety\u002Fdepression. The study will compare these two approaches to see which is more effective. To join, you need to be a first-generation college student, 18 or older, enrolled in a four-year college in the U.S., have internet access, and speak English. The goal is to enroll 53 participants.","Participants will be followed for one month after the final treatment session to assess outcomes.",119,"You would participate in a 30-minute session once a week for four weeks, delivered remotely. Your intention to persist in college, depression, and anxiety will be assessed at the start, one week after the last session, and one month later.","Not stated in the trial record.",[31,35],"v2"]