xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06013930</url>
    </required_header>
    <id_info>
      <org_study_id>22-247</org_study_id>
      <nct_id>NCT06013930</nct_id>
    </id_info>
    <brief_title>Exploring the Efficacy of Treatments for Anxiety and Depression Among College Students</brief_title>
    <official_title>Exploring the Efficacy of Alternative Treatments for Depression and Anxiety Among College Students: A Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of South Dakota</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Subtle Energy Funders Collective</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of South Dakota</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized control group is to learn about effective treatments for college&#xD;
        students experiencing anxiety and/or depression. The main questions this clinical trial aims&#xD;
        to answer are: 1) Can alternative treatments decrease anxiety and/or depression among college&#xD;
        students? 2) Can alternative treatments increase retention rates among college students&#xD;
        experiencing anxiety and/or depression?&#xD;
  &#xD;
        Participants will be randomly assigned to one of three intervention groups: external qigong,&#xD;
        mindfulness meditation, or psychoeducation. Researchers will compare outcomes from each group&#xD;
        to explore treatment differences.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Method/Design. This study will be a single-site, three-arm, randomized, controlled trial.&#xD;
        College students (N=51) with elevated depression and/or anxiety will be randomized to either&#xD;
        external qigong (EQ), mindfulness meditation (MM), or psychoeducation (PE). Each intervention&#xD;
        will be applied for 30 minutes, once a week for three weeks in a community setting. The&#xD;
        co-primary outcomes, depression and anxiety, and the secondary outcome, intention to persist&#xD;
        in college, will be assessed by a blinded researcher at baseline, one-week post treatment,&#xD;
        and one-month follow-up. Change in sense of connection during the treatment session, measured&#xD;
        with a comprehensive battery of self-report indices, will be the primary therapeutic&#xD;
        mechanism.&#xD;
  &#xD;
        Aims and Objectives. The proposed project's central hypothesis is that EQ will increase&#xD;
        students' mental health and intention to persist in college by balancing the flow of energy&#xD;
        in their bodies. Aim 1. Examine EQ's acceptability in a sample of college students with&#xD;
        depression and/or anxiety. Hypothesis: Student retention (i.e., attendance in both treatment&#xD;
        sessions) and self-reported treatment acceptability will be better for EQ relative to PE. EQ&#xD;
        and MM will demonstrate equivalent acceptability. Aim 2. Determine EQ's effect on anxiety,&#xD;
        depression (co-primary outcomes), and intention to persist in college (secondary outcome)&#xD;
        over time. Hypothesis: EQ will decrease depression and anxiety while increasing intention to&#xD;
        persist in college relative to PE from baseline to one-month follow-up. The co-primary and&#xD;
        secondary outcome scores will not differ between EQ and MM. Aim 3. Investigate EQ's immediate&#xD;
        effect on students' sense of connection (therapeutic mechanism). Hypothesis: EQ will increase&#xD;
        students' sense of connection relative to PE during the treatment sessions. EQ and MM will&#xD;
        have equivalent effects on sense of connection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants will be randomized to receive either: 1) External Qigong, 2) Mindfulness Meditation, or 3) Psychoeducation.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The PI will randomly assign participants to condition and coordinate treatment group scheduling; the assessor will be blinded to condition.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Anxiety</measure>
      <time_frame>Change from baseline assessment, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).</time_frame>
      <description>Symptoms of anxiety will be assessed through a trait anxiety assessment (State-Trait-Anxiety Inventory). The range of possible scores spans from a minimum score of 20 to a maximum score of 80 - the higher the score, the higher the symptoms of anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depression</measure>
      <time_frame>Change from baseline assessment, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).</time_frame>
      <description>Symptoms of depression will be assessed through a trait depression assessment (Beck Depression Inventory). Scores from the Beck Depression Inventory range from 0-63, with higher scores representing high depression levels.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intention to persist in college</measure>
      <time_frame>Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <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, external qigong, and psychoeducation).</time_frame>
      <description>Symptoms will be assessed through a state anxiety assessment. Scores range from 0-60 with higher scores indicating higher levels of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>Changes in participant's state depression will be captured within 5-minutes prior to each intervention and within 5 minutes after each intervention (mindfulness, external qigong, and psychoeducation).</time_frame>
      <description>Symptoms will be assessed through a state depression assessment. Scores range from 0-20 with higher scores indicating higher levels of depression.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adverse Childhood Experiences questionnaire.</measure>
      <time_frame>Baseline</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Sensation Manikin</measure>
      <time_frame>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).</time_frame>
      <description>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).</description>
    </other_outcome>
    <other_outcome>
      <measure>Trait Self-Transcendence</measure>
      <time_frame>Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).</time_frame>
      <description>Change in trait self-transcendence from baseline through 3-month follow-up will be assessed with the Nondual Awareness Dimensional Assessment - Trait Version. Scores range from 0 to 52, with higher scores reflecting greater trait self-transcendence.</description>
    </other_outcome>
    <other_outcome>
      <measure>Self-Transcendent State</measure>
      <time_frame>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).</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Perceived Discrimination</measure>
      <time_frame>Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).</time_frame>
      <description>Changes in the perception of experiencing discrimination (Everyday Discrimination). Scores range from 0 -54 with higher scores indicating higher levels of discrimination.</description>
    </other_outcome>
    <other_outcome>
      <measure>Connectedness to Nature Questionnaire</measure>
      <time_frame>Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Dispositional Mindfulness Scale</measure>
      <time_frame>Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Sense of Belonging in College</measure>
      <time_frame>Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).</time_frame>
      <description>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.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">51</enrollment>
    <condition>Anxiety</condition>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>External Qigong</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will meet individually with the Qigong practitioner once a week for three weeks for 30-minute segments.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mindfulness Meditation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will meet individually with the mindfulness practitioner once a week for three weeks for 30-minute segments.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Psychoeducation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the psychoeducation arm, participants will receive recordings online, once a week for three weeks which will be approximately 30 minutes in length.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>External Qigong</intervention_name>
      <description>External Qigong will be facilitated by a seasoned Qigong practitioner. The Qigong practitioner will assist participants in learning how to use the healing powers of their bodies to decrease feelings of anxiety and/or depression</description>
      <arm_group_label>External Qigong</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness Meditation</intervention_name>
      <description>Mindfulness meditation will be facilitated by a seasoned mindfulness practitioner. Participants will be guided through a meditation 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.</description>
      <arm_group_label>Mindfulness Meditation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Psychoeducation</intervention_name>
      <description>In the psychoeducation arm, participants will receive information related to managing anxiety and/or depression through a recorded presentation. Participants will learn about stress-management techniques to help reduce symptoms of anxiety and/or depression. They will also receive information on resources that could be helpful in treating anxiety and/or depression.</description>
      <arm_group_label>Psychoeducation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years or older.&#xD;
  &#xD;
            -  Currently enrolled in a two or four-year college.&#xD;
  &#xD;
            -  English speaking.&#xD;
  &#xD;
            -  Willing to travel to the study location.&#xD;
  &#xD;
            -  Access to a computer or smartphone with a Wifi connection.&#xD;
  &#xD;
            -  Score of a three or higher on the Generalized Anxiety Disorder 2-item and/or score of&#xD;
               a three or higher on the Patient Health Questionnaire-2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not currently enrolled in college.&#xD;
  &#xD;
            -  Not able to travel to the study location.&#xD;
  &#xD;
            -  No access to a computer or smartphone with Wifi.&#xD;
  &#xD;
            -  Score &lt; 3 on the Generalized Anxiety Disorder-2 and &lt; 3 on the Patient Health&#xD;
               Questionnaire-2.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Natalie Lecy, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Natalie Lecy, PhD</last_name>
      <phone>6058644151</phone>
      <email>natalie.lecy@usd.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of South Dakota</name>
        <address>
          <city>Sioux Falls</city>
          <state>South Dakota</state>
          <zip>57107</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Natalie Lecy, PhD</last_name>
        <phone>801-910-3165</phone>
        <email>natalie.lecy@usd.edu</email>
      </contact>
      <investigator>
        <last_name>Natalie Lecy, Phd</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>11597055</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31246748</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30058824</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33091745</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>19341164</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>9635069</PMID>
    </reference>
    <reference>
      <citation>Navarro O, Olivos P, Fleury-Bahi G. &quot;Connectedness to Nature Scale&quot;: Validity and Reliability in the French Context. Front Psychol. 2017 Dec 12;8:2180. doi: 10.3389/fpsyg.2017.02180. eCollection 2017.</citation>
      <PMID>29312052</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06013930
  org study id: 22-247
  nct id: NCT06013930
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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 alternative treatments decrease anxiety and/or depression among college
        students? 2) Can alternative treatments increase retention rates among college students
        experiencing anxiety and/or depression?
  
        Participants will be randomly assigned to one of three intervention groups: external qigong,
        mindfulness meditation, or psychoeducation. Researchers will compare outcomes from each group
        to explore treatment differences.
  Method/Design. This study will be a single-site, three-arm, randomized, controlled trial.
        College students (N=51) with elevated depression and/or anxiety will be randomized to either
        external qigong (EQ), mindfulness meditation (MM), or psychoeducation (PE). Each intervention
        will be applied for 30 minutes, once a week for three weeks in a community setting. The
        co-primary outcomes, depression and anxiety, and the secondary outcome, intention to persist
        in college, 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 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 EQ will increase
        students' mental health and intention to persist in college by balancing the flow of energy
        in their bodies. Aim 1. Examine EQ's acceptability in a sample of college students with
        depression and/or anxiety. Hypothesis: Student retention (i.e., attendance in both treatment
        sessions) and self-reported treatment acceptability will be better for EQ relative to PE. EQ
        and MM will demonstrate equivalent acceptability. Aim 2. Determine EQ's effect on anxiety,
        depression (co-primary outcomes), and intention to persist in college (secondary outcome)
        over time. Hypothesis: EQ will decrease depression and anxiety while increasing intention to
        persist in college relative to PE from baseline to one-month follow-up. The co-primary and
        secondary outcome scores will not differ between EQ and MM. Aim 3. Investigate EQ's immediate
        effect on students' sense of connection (therapeutic mechanism). Hypothesis: EQ will increase
        students' sense of connection relative to PE during the treatment sessions. EQ and MM will
        have equivalent effects on sense of connection.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomized to receive either: 1) External Qigong, 2) Mindfulness Meditation, or 3) Psychoeducation.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The PI will randomly assign participants to condition and coordinate treatment group scheduling; the assessor will be blinded to condition.
  measure: Anxiety
  time frame: Change from baseline assessment, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
  description: Symptoms of anxiety will be assessed through a trait anxiety assessment (State-Trait-Anxiety Inventory). The range of possible scores spans from a minimum score of 20 to a maximum score of 80 - the higher the score, the higher the symptoms of anxiety.
  measure: Depression
  time frame: Change from baseline assessment, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
  description: Symptoms of depression will be assessed through a trait depression assessment (Beck Depression Inventory). Scores from the Beck Depression Inventory range from 0-63, with higher scores representing high depression levels.
  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).
  description: 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.
  measure: 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, external qigong, and psychoeducation).
  description: Symptoms will be assessed through a state anxiety assessment. Scores range from 0-60 with higher scores indicating higher levels of anxiety.
  measure: Depression
  time frame: Changes in participant's state depression will be captured within 5-minutes prior to each intervention and within 5 minutes after each intervention (mindfulness, external qigong, and psychoeducation).
  description: Symptoms will be assessed through a state depression assessment. Scores range from 0-20 with higher scores indicating higher levels of depression.
  measure: Adverse Childhood Experiences questionnaire.
  time frame: Baseline
  description: 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.
  measure: Sensation Manikin
  time frame: 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).
  description: 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).
  measure: Trait Self-Transcendence
  time frame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
  description: Change in trait self-transcendence from baseline through 3-month follow-up will be assessed with the Nondual Awareness Dimensional Assessment - Trait Version. Scores range from 0 to 52, with higher scores reflecting greater trait self-transcendence.
  measure: Self-Transcendent State
  time frame: 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).
  description: 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.
  measure: Perceived Discrimination
  time frame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
  description: Changes in the perception of experiencing discrimination (Everyday Discrimination). Scores range from 0 -54 with higher scores indicating higher levels of discrimination.
  measure: Connectedness to Nature Questionnaire
  time frame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
  description: 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: Dispositional Mindfulness Scale
  time frame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
  description: 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: Sense of Belonging in College
  time frame: Baseline, post treatment (one week after the final treatment session), and follow-up (one month after the final treatment session).
  description: 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.
  arm group label: External Qigong
  arm group type: Experimental
  description: Participants will meet individually with the Qigong practitioner once a week for three weeks for 30-minute segments.
  arm group label: Mindfulness Meditation
  arm group type: Experimental
  description: Participants will meet individually with the mindfulness practitioner once a week for three weeks for 30-minute segments.
  arm group label: Psychoeducation
  arm group type: Active Comparator
  description: In the psychoeducation arm, participants will receive recordings online, once a week for three weeks which will be approximately 30 minutes in length.
  intervention type: Behavioral
  intervention name: External Qigong
  description: External Qigong will be facilitated by a seasoned Qigong practitioner. The Qigong practitioner will assist participants in learning how to use the healing powers of their bodies to decrease feelings of anxiety and/or depression
  arm group label: External Qigong
  intervention type: Behavioral
  intervention name: Mindfulness Meditation
  description: Mindfulness meditation will be facilitated by a seasoned mindfulness practitioner. Participants will be guided through a meditation 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.
  arm group label: Mindfulness Meditation
  intervention type: Other
  intervention name: Psychoeducation
  description: In the psychoeducation arm, participants will receive information related to managing anxiety and/or depression through a recorded presentation. Participants will learn about stress-management techniques to help reduce symptoms of anxiety and/or depression. They will also receive information on resources that could be helpful in treating anxiety and/or depression.
  arm group label: Psychoeducation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Natalie Lecy, PhD
  role: Principal Investigator
  affiliation: Assistant Professor
  last name: Natalie Lecy, PhD
  phone: 6058644151
  email: natalie.lecy@usd.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Anxiety Disorders
  sharing ipd: Undecided