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Mindfulness Meditation Neuroimaging Study for Undergraduates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05304052
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : August 4, 2022
Sponsor:
Information provided by (Responsible Party):
Julienne Bower, PhD, University of California, Los Angeles

Brief Summary:

This study is designed to test the effectiveness of mindfulness meditation intervention classes on psychosocial health outcomes. Additionally, the investigators would like to examine changes in the brain that might occur following the mindfulness meditation intervention. The investigators are particularly interested in changes in brain activity that are correlated with changes in inflammation-related markers in the blood. The nervous system and immune system are closely connected, and both are influenced by mindfulness. However, it is unclear whether changes in neural activity are linked with changes in inflammation. A compelling feature of mindfulness interventions is their potential for reducing inflammatory activity; however, this has not been examined in college students. In addition to measuring psychosocial outcomes, the investigators will employ sophisticated, vertically-integrated measures of inflammatory biology that allow the study team to probe intervention effects on circulating markers of inflammation.

Thus, the investigators intend to recruit 60 undergraduate students and will randomize them into either a 6-week standardized mindfulness intervention or to a wait-list control group. Participants will complete brain scans, provide blood samples for immune analysis, and complete questionnaires at pre- and post-intervention assessments


Condition or disease Intervention/treatment Phase
Inflammation Psychosocial Functioning Depression, Anxiety Behavioral: Mindfulness Meditation classes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After completing the pre-intervention assessment (consisting of completing an online survey, a blood draw and brain scan while performing tasks in a fMRI machine), students will be randomized to one of the two study conditions. Study subjects will be informed of their assigned condition and those assigned to the mindfulness meditation class will be provided with specific details for the class, while those assigned to the wait list control group won't be expected to do anything during the six week class schedule, other than not to take any meditation classes.
Masking: Single (Outcomes Assessor)
Masking Description: Study coordinators who will be consenting and responsible for the pre-treatment and post-treatment assessments will be masked so that they will not have any bias as to which students participated in the mindfulness meditation intervention and which were in the wait list control group. A research associate who will not be participating in the assessments will be the one to call subjects and inform them of their assigned study arm.
Primary Purpose: Basic Science
Official Title: Mindful Awareness Practices vs. Wait List Control Randomized Controlled Trial for College Students: Effects on Psychosocial Outcomes and Neural and Immune Processes
Actual Study Start Date : March 27, 2022
Estimated Primary Completion Date : June 26, 2023
Estimated Study Completion Date : June 26, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness meditation intervention
Half of the subjects will be randomly assigned to participate in the mindfulness meditation intervention. This class will meet once a week, for two hours, over the course of six weeks.
Behavioral: Mindfulness Meditation classes
The mindful awareness practices (MAPS) intervention is based on an institutional program developed by the Mindful Awareness Research Center (MARC) at UCLA, but takes a more practical and accessible approach that focuses specifically on the practice of mindfulness and its application in everyday life (as compared to the focus on stress and stress reduction in mindfulness-based stress reduction). Key components of the intervention include development of bodily awareness, managing pain, working with difficult thoughts and feelings, cultivating positive emotions and loving kindness, and relational mindfulness practices. Each session provides structured training and exercises in mindfulness, including formal meditation practices and strategies for the daily informal use of mindfulness, as well as opportunity for group discussion and sharing. Participants will be instructed to practice mindfulness techniques on a daily basis, beginning with five minutes and increasing to 20 minutes.

No Intervention: Wait list control
Half of the subjects will be randomly assigned to be in the wait-list control group. These subjects will not be asked to do anything during the six weeks while the mindfulness meditation group takes place, other than to not enroll in a meditation class.



Primary Outcome Measures :
  1. Psychological well-being [ Time Frame: Baseline and at 8 weeks ]

    Change in psychological well-being

    Well-being will be measured via the 14-item Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is comprised of three empirically derived subscales: the 3-item Emotional Well-Being Subscale, the 6-item Psychological Well-Being Subscale, and the 5-item Social Well-Being Subscale. Higher scores on each subscale, and the total score overall (range: 0-56), indicate greater well-being.


  2. Depression [ Time Frame: Baseline and at 8 weeks ]

    Change in depressive symptoms

    Depressive symptoms will be measured via the 20-item Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a measure of symptom severity, with higher scores (range: 0-60) indicating greater depressive symptoms


  3. Anxiety [ Time Frame: Baseline and at 8 weeks ]

    Change in anxiety

    Symptoms of anxiety will be measured via the 7-item Generalized Anxiety Disorder- 7 (GAD-7). Higher scores on the GAD-7 (range: 0-21) indicate greater severity of symptoms.


  4. Perceived stress [ Time Frame: Baseline and at 8 weeks ]
    Change in perceived stress Perceived stress will be measured via the 10-item Perceived Stress Scale (range: 0-40). Higher scores indicate greater perceived stress levels.


Secondary Outcome Measures :
  1. Inflammation [ Time Frame: Baseline and at 8 weeks ]
    The primary immune outcome of interest is inflammatory gene expression, measured through a set of 19 pre-specified pro-inflammatory gene transcripts that have previously been shown to be upregulated in the context of chronic stress and downregulated by the mindfulness meditation intervention. The inflammatory composite includes the following genes: IL1A, IL1B, IL6, IL8, TNF, PTGS1, PTGS2, FOS, FOSB, FOSL1, FOSL2, JUN, JUNB, JUND, NFKB1, NFKB2, REL, RELA, and RELB)

  2. Mindfulness [ Time Frame: Baseline and at 8 weeks ]

    Change in Mindfulness

    Mindfulness will be measured via the 39-item Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ has both direct and reverse scoring items and is comprised of 5 subscales: observing, describing, acting with awareness, non-judgment and non-reactivity, along with an overall mindfulness score. The total FFMQ can be divided by 39 to get an average item score. Scores represent a spectrum of mindfulness.


  3. Positive and negative affect [ Time Frame: Baseline and at 8 weeks ]

    Change in positive and negative affect

    Reports of positive and negative affect will be assessed via the 10-item positive affect subscale and 10-item negative affect subscales of the Positive and Negative Affect Schedule (PANAS-X). Two additional adjectives were also included, happy and calm. Greater scores indicate higher feelings of positive (range: 10-50) and negative affect (range: 10-50).


  4. Anhedonia [ Time Frame: Baseline and at 8 weeks ]

    Change in anhedonia

    Anhedonia will be measured via the 14-item Snaith-Hamilton Pleasure Scale which covers domains of social interaction, food and drink, sensory experiences and interests/pastimes. Scores range from 0-14 with higher scores indicating the inability to experience pleasure.


  5. Loneliness [ Time Frame: Baseline and at 8 weeks ]

    Change in loneliness

    Loneliness will be measured via the 3-item UCLA Loneliness Scale (range: 3-9). Higher scores indicate greater loneliness


  6. Rumination [ Time Frame: Baseline and at 8 weeks ]

    Change in Rumination

    Rumination will be measured via the 6-item rumination subscale from the Rumination and Reflection questionnaire. Some items require reverse scoring. Rumination reflects a tendency to focus on negative self-perceptions.


  7. Compassion for others [ Time Frame: Baseline and at 8 weeks ]
    Change in compassion for others Compassion for others will be measured via the 16-item Compassion scale. This measure contains four subscales: greater kindness, common humanity, mindfulness and lessened indifference. Some items are reverse scored. Each scale is scored by taking the mean.

  8. Sleep disruption (sleep latency, sleep duration, sleep efficiency, sleep disturbance and daytime dysfunction) [ Time Frame: Baseline and at 8 weeks ]

    Changes in sleep disruption will be examined by looking at changes in sleep latency, sleep duration, sleep efficiency, sleep disturbance and daytime dysfunction.

    Sleep disruption will be measured via the Pittsburgh Sleep Quality Index. 19 self-rated items are combined to form seven "component" scores, (sleep latency, sleep duration, sleep efficiency, sleep disturbance, daytime dysfunction, with subjective sleep quality rated by participant, and use of sleep medications included in scale) each of which ranges from 0-3 points ("0 indicates no difficulty, while "3" indicates severe difficulty). The seven component scores are combined into one "global" score, ranging from 0-21 points. Higher scores indicate greater sleep disruption.


  9. Savoring strategies [ Time Frame: Baseline and at 8 weeks ]

    Change in savoring strategies

    The degree to which people engage in savoring strategies will be measured via the 60-item Ways of Savoring Checklist (WOSC) scale. This measure contains three subscales of interest when it comes to mindfulness: absorption, temporal awareness, and kill-joy thinking items. Some items are reverse scored. Each scale is scored by taking the mean.


  10. Self-concept [ Time Frame: Baseline and at 8 weeks ]
    Change in self-concept Self-concept will be measured via the 20-item Tennessee Self-concept short form scale (TSCS-SF). This short form version measures total self-concept with higher scores indicating greater strength in one's self-view.

  11. Self-compassion [ Time Frame: Baseline and at 8 weeks ]

    Change in self-compassion

    Self-compassion will be measured via the 26-item Self-compassion scale. This scale contains 6 subscales: self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification. Subscale scores are computed by calculating the mean of subscale item responses or a total self-compassion score can be computed after reverse scoring the negative subscale items and then computing a mean. There are no clinical scores which indicate that an individual is high or low in self-compassion. Rather, scores are often used in a comparative manner to examine outcomes for people who score either higher or lower in self-compassion.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Undergraduate students at UCLA
  • Must live on the UCLA campus
  • Must be right-handed (for the fMRI scan)

Exclusion Criteria:

  • Current diagnosis of mood or anxiety disorder as determined by the PHQ-8 or by the GAD-7 if score "15" or more on either measure
  • Presence of medical conditions or use of medications that may influence inflammation (e.g., autoimmune disorder)
  • Regular tobacco use
  • Actively practicing mindfulness meditation
  • Left-handed (for the fMRI scan)
  • BMI > 30 (for the fMRI scan)
  • Pregnant (for the fMRI scan)
  • Color blind (for the fMRI scan)
  • Non-removable metal in body (for the fMRI scan)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05304052


Contacts
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Contact: Deborah E Garet, MPH (310) 975-9035 dgaret@mednet.ucla.edu
Contact: Michael Parrish, MA (910) 547-5356 michparr21@gmail.com

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Deborah E Garet, MPH    310-975-9035    dgaret@mednet.ucla.edu   
Contact: Michael Parrish, MA    (910) 547-53556    michparr21@gmail.com   
Sub-Investigator: Chloe C Boyle, Ph. D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Julienne E Bower, Ph.D. University of California, Los Angeles
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Responsible Party: Julienne Bower, PhD, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05304052    
Other Study ID Numbers: 21-002038
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share any individual participant data (IPD) with any other researchers. Data will be reported in group form to prevent personal identification of participants. When the research has been completed, the data will be stored in a secured area of a private, locked research office. Any personal identifiers and/or codes linking the data to personal identifiers will be kept on a separate computer with password protection for reference and for future research. All personal identifiers will be kept confidential. Only identified members of the research team and the P.I. will have access to the data, identifiers and/or codes. Data with subject identifiers will not be released to any agency or persons.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julienne Bower, PhD, University of California, Los Angeles:
adolescents
mindfulness meditation
brain imaging
inflammation
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes