Recruiting NCT06789731

Mindfulness-Based Interventions Targeting First-Generation College Student Retention in Rural Environments

No phase Interventional Depression Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Mindfulness Meditation, Psychoeducation.
Who it may be relevant to: Registry conditions: Depression, Anxiety. Basic parameters: 18 years — 64 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The goal of this randomized control group is to learn about effective treatments for college students experiencing anxiety and/or 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/or depression among first-generation college students? Participants 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.

Detailed description

Method/Design. 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.

Aims 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.

Exploratory. 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.

Interventions

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/or depression into sensory, emotional, cognitive, and behavioral components.
Other Psychoeducation
In the psychoeducation arm, participants will receive information related to creating connections with campus community and managing anxiety and/or depression through a presentation. They will also receive information on resources for connecting with their community and treating anxiety and/or depression.

Primary outcome measures

Intention to Persist in College [Time frame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session)]

Secondary outcome measures (2)

Anxiety [Time frame: 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)]
Depression [Time frame: 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)]

Eligibility criteria

Inclusion criteria

18 years or older. Currently enrolled in four-year college in the United States. First-generation college student. Access to WiFi and a computer/smartphone/tablet. English speaking.

Exclusion criteria

Not currently enrolled in a four-year college. Not a first-generation college student. Non-English speaker. Not able to utilize WiFi or computer/tablet/smartphone.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment

Study locations

United States · 1 center

University of South Dakota — Sioux Falls

Publications

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/pr0.2001.88.3c.1075. PMID 11597055
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/PSY.0000000000000725. PMID 31246748
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/pas0000615. Epub 2018 Jul 30. PMID 30058824
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/j.cpr.2020.101928. Epub 2020 Oct 10. PMID 33091745
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 19341164
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/s0749-3797(98)00017-8. PMID 9635069
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/fpsyg.2017.02180. eCollection 2017. PMID 29312052

Identifiers

NCT: NCT06789731 · 23-117

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗