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InflammationNCT05304052

Mindfulness Meditation Neuroimaging Study for Undergraduates

A study testing Mindfulness Meditation classes in people with Inflammation and Psychosocial Functioning, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Mindfulness Meditation classes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteUnited States
Study dates
27 Mar 2022to 10 Jun 2023
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 9Show fewer
  • Pregnant (for the fMRI scan)
  • Color blind (for the fMRI scan)
  • Non-removable metal in body (for the fMRI scan)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Los Angeles

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Mindful Awareness Practices vs. Wait List Control Randomized Controlled Trial for College Students: Effects on Psychosocial Outcomes and Neural and Immune Processes

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

Read the detailed description

Psychosocial symptoms, such as depression and anxiety, are often elevated in adolescents, particularly as they transition to college. Mental health stress can also lead to negative effects in underlying biological markers of health, such as inflammation. Inflammation is linked to alterations in emotion, cognitive function, and behavior, and is increasingly recognized as a key contributor to mental and physical health.

Mindfulness-based interventions (MBIs) offer a promising alternative for addressing psychosocial symptoms among college students. Mindfulness involves bringing attention to one's present moment experiences, including thoughts, feelings, and physical sensations, with openness, curiosity, and absence of judgment. Interventions have been developed to cultivate mindfulness through formal meditation and informal practice, and RCTs (randomized controlled trials) have documented benefits of mindfulness-based interventions on psychological and biological health outcomes.

The UCLA Mindful Awareness Research Center (MARC) has developed and validated a group-based mindfulness intervention, Mindful Awareness Practices (MAPs), that has demonstrated beneficial effects on mental health in adults and may offer a promising, scalable approach for improving associated psychological and biological outcomes in college students. More rigorous evaluation among college students, relative to a wait list control condition, is required for validation and before broad implementation of this promising approach can occur.

Overview: The proposed randomized controlled trial (RCT) will investigate the effect of a standardized mindfulness intervention on psychological, neural, and inflammatory processes in college students compared to a wait list control group. Furthermore, the investigators will examine the association between changes in psychological, neural, and immune outcomes.

Participants: Study participants will be undergraduate students at the University of California, Los Angeles (UCLA). They will be recruited in cohorts of 30 and randomized 1:1 to one of the two study arms (15 students in MAPs class/15 wait list control). Participants will complete online questionnaires, a functional magnetic resonance imaging (fMRI) scan and will provide blood samples before and after the six-week intervention period.

Screening: Potential subjects will be screened for eligibility over the phone. The 4-item Patient Health Questionnaire (PHQ4) will be administered to assess mood (depression and anxiety). If a potential subject scores a "3" on either subscale, the study coordinator will administer the 8-item Patient Health Questionnaire (PHQ8)(for depression) or the GAD-7 (for anxiety) to determine the severity. If the potential participant scores "15" or more on either scale, they will be referred to the UCLA Counseling and Psychological Services (CAPS).

Enrollment and Baseline Assessment (T1): All students who are determined to be eligible will be scheduled for an in-person, baseline assessment (T1) at the UCLA Health Psychology Laboratory (HPL). The Institutional Review Board (IRB) approved consent form will be reviewed and signed. A pre-intervention online survey will also be completed during this initial in-person visit. The survey will consist of the following scales: Background demographic characteristics, health behaviors, Pittsburgh Sleep Quality Index (PSQI), Center for Epidemiological Studies-Depression (CES-D), Snaith-Hamilton Pleasure scale (SHAPS), Generalized Anxiety Disorder-7 (GAD-7), Perceived Stress Scale (PSS), UCLA Loneliness Scale, Positive and Negative affect (PANAS-X), Mental Health Continuum-short form, Mindfulness scale (FFMQ), Self-compassion scale, Rumination and reflection questionnaire, Ways of Savoring checklist (WOSC), Compassion scale and the Tennessee Self-concept short form scale (TSCS) .

Participants will provide blood samples for immune evaluation. Due to changes in research procedures due to COVID-19, the investigators would like to change the usual method for blood collection. Prior to COVID-19, blood was drawn by venipuncture by a licensed phlebotomist. However, in order to mitigate risk and abide to social distancing guidelines. the investigators now plan to collect blood by utilizing the Tasso OnDemand device, which allows self-collection of a single capillary blood sample and does not require venipuncture. The Tasso device sticks to the skin with a light adhesive. When the button is pressed, a vacuum forms and a lancet pricks the surface of the skin. The vacuum draws blood out of the capillaries and into a sample pod attached to the bottom of the device. The participant would watch a demonstration video during their baseline assessment visit, and then use the device to collect a blood sample. Approximately 1/8th of a teaspoon of blood will be drawn at each in-person assessment.

Subjects will also complete a 75 minute scan while lying in a fMRI machine. During the neuroimaging session, participants will undergo a series of probe tasks that are known to activate the neural regions of interest. In particular, the investigators will evaluate activity in the amygdala and related "neural alarm" regions in response to threat-related tasks, which the investigators hypothesize will decrease following mindfulness training. In addition, the investigators will examine activity in reward-related regions following compassion and self-affirmation tasks, which the investigators hypothesize will increase following mindfulness.

Baseline visits will be conducted in the 2-week period before intervention onset.

Randomization: After completing the baseline assessment, participants will be randomized to one of the two study conditions. The coordinator will inform the participants of their assigned condition and will provide information to those who will be taking the MAPs classes (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).

Intervention: Mindful Awareness Practices (MAPs): Participants assigned to this condition will be asked to attend two-hour group sessions once a week for six weeks. The MAPs intervention is based on an institutional program developed by the Mindful Awareness Research Center (MARC) at UCLA. The MAPs program is similar to other mindfulness-based interventions in its general focus on cultivating mindfulness, 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. Home practice is a key component of MAPs. Participants will be instructed to practice mindfulness techniques on a daily basis, beginning with five minutes and increasing to 20 minutes. Subjects will be asked to complete daily homework logs throughout the 6-weeks.

The MAPs curriculum will be implemented by trained instructors who will receive specialized training in delivery of the study-specific protocol and will be overseen by Dr. Marvin Belzer, Associate Director of the MARC and master instructor for this trial. MAPs classes will be held in private rooms in the residential part of the UCLA campus, close to student living quarters. MAPs classes will be conducted in the evenings and scheduled to occur mid-way through the quarter to minimize conflict with classes and exam periods.

Immediate Post-Intervention Assessment (T2): This in-person visit will be scheduled to occur within 2 weeks after the conclusion of the study interventions at the UCLA Health Psychology Lab and will include completion of a post-intervention online questionnaire (all scales from the baseline will be administered again except for the demographic characteristics), collection of blood samples using the TASSO OnDemand device (approximately 1/8 teaspoon), and another 75 minute fMRI neuroimaging session.

After the post-intervention assessments have been completed, students who were assigned to the wait-list control group will be offered the opportunity to take the MAPs class.

Being tested
Mindfulness Meditation classes
Keywords
adolescents, mindfulness meditation, brain imaging, inflammation
Medical subject headings
Inflammation, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Meditation classesBehavioural

    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.

Study groups in NCT05304052
Study groupRoleWhat they receive
Mindfulness meditation interventionExperimentalHalf 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.
Receives: Behavioral: Mindfulness Meditation classes
Wait list controlNo interventionHalf 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychological well-being

    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.

    Measured: Baseline and at 8 weeks

  2. Depression

    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

    Measured: Baseline and at 8 weeks

  3. Anxiety

    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.

    Measured: Baseline and at 8 weeks

  4. Perceived stress

    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.

    Measured: Baseline and at 8 weeks

Secondary outcomes (11)
  1. Inflammation

    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)

    Measured: Baseline and at 8 weeks

  2. Mindfulness

    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.

    Measured: Baseline and at 8 weeks

  3. Positive and negative affect

    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).

    Measured: Baseline and at 8 weeks

  4. Anhedonia

    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.

    Measured: Baseline and at 8 weeks

  5. Loneliness

    Change in loneliness

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

    Measured: Baseline and at 8 weeks

  6. Rumination

    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.

    Measured: Baseline and at 8 weeks

  7. Compassion for others

    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.

    Measured: Baseline and at 8 weeks

  8. Sleep disruption (sleep latency, sleep duration, sleep efficiency, sleep disturbance and daytime dysfunction)

    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.

    Measured: Baseline and at 8 weeks

  9. Savoring strategies

    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.

    Measured: Baseline and at 8 weeks

  10. Self-concept

    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.

    Measured: Baseline and at 8 weeks

  11. Self-compassion

    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.

    Measured: Baseline and at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start27 Mar 2022
  3. Primary completion10 Jun 2023
  4. Study completion10 Jun 2023

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304052
Sponsor's protocol ID
21-002038
Status last verified
Nov 2023
First submitted
9 Feb 2022
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Meditation classes in people with Inflammation and Psychosocial Functioning, run by University of California, Los Angeles 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 3 inclusion and 9 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 1 Dec 2023. 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?

Psychological well-being (time frame: Baseline and at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 Dec 2023.

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