DepressionNCT06789731
Mindfulness-Based Interventions Targeting First-Generation College Student Retention in Rural Environments
A study testing Mindfulness Meditation and Psychoeducation in people with Depression and Anxiety, run by University of South Dakota at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Mindfulness Meditation and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 24 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years or older. Currently enrolled in college in the United States. First-generation college student. Access to WiFi and a computer/smartphone/tablet. English speaking.
Who cannot join
- Not currently enrolled in a college program. Not a first-generation college student. Non-English speaker. Not able to utilize WiFi or computer/tablet/smartphone.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Dakota
Sioux Falls, South Dakota, 57107
About this study
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.
Read the detailed description
Method/Design. This study will be a remote, two-arm, randomized, controlled trial. First-generation college students 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 60 minutes, once a week, for two 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.
- Conditions
- Depression, Anxiety
- Being tested
- Mindfulness Meditation, Psychoeducation
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
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.
PsychoeducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation | Experimental | Participants will meet virtually with the mindfulness practitioner once a week for two weeks for 60-minute segments. Receives: Behavioral: Mindfulness Meditation |
| Psychoeducation | Active comparator | Participants will receive recordings online, once a week for two weeks which will be approximately 60 minutes in length. Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session)
Secondary outcomes (2)
Anxiety
Symptoms will be assessed through a state anxiety assessment. Scores range from 0-60 with higher scores indicating higher levels of anxiety.
Measured: 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
Symptoms will be assessed through a state depression assessment. Scores range from 0-20 with higher scores indicating higher levels of depression.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Jan 2025
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive either: 1) Mindfulness Meditation or 2) Psychoeducation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Dakota
- Sponsor type
- University, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts
- Responsible party
- Sponsor
- Investigators
- Natalie Lecy, Principal investigator, University of South Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789731
- Sponsor's protocol ID
- 23-117
- Status last verified
- Aug 2026
- First submitted
- 17 Jan 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 11597055Hanley 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.
PubMed 31246748Hanley 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.
PubMed 30058824Knowles 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.
PubMed 33091745Sims 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.
PubMed 19341164Felitti 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.
PubMed 9635069Navarro 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.
PubMed 29312052
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Interventions Targeting First-Generation College Student Retention in Rural Environments
- ClinicalTrials.gov ID
- NCT06789731
- Acronym / sponsor ID
- 23-117
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of South DakotaUniversity, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 60 minutes, once a week, for two 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive either: 1) Mindfulness Meditation or 2) Psychoeducation
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation | Experimental | Behavioral: Mindfulness MeditationParticipants will meet virtually with the mindfulness practitioner once a week for two weeks for 60-minute segments. |
| Psychoeducation | Active comparator | Other: PsychoeducationParticipants will receive recordings online, once a week for two weeks which will be approximately 60 minutes in length. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18 years or older. Currently enrolled in college in the United States. First-generation college student. Access to WiFi and a computer/smartphone/tablet. English speaking.
Key exclusion criteria (1 listed)
- Not currently enrolled in a college program. Not a first-generation college student. Non-English speaker. Not able to utilize WiFi or computer/tablet/smartphone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness MeditationMindfulness 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. | Behavioural | Mindfulness Meditation |
| PsychoeducationIn 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. | Other | Psychoeducation |
Primary outcome
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)
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.
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 11597055Steer 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.
- Background: PubMed 31246748Hanley 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.
- Background: PubMed 30058824Hanley 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.
- Background: PubMed 33091745Knowles 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.
- Background: PubMed 19341164Sims 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.
- Background: PubMed 9635069Felitti 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.
- Background: PubMed 29312052Navarro 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Lecy principal investigator
University of South Dakota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation and Psychoeducation in people with Depression and Anxiety, run by University of South Dakota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06789731, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.