Clinical trial NCT05304052: Mindfulness Meditation Neuroimaging Study for Undergraduates
Official title: Mindful Awareness Practices vs. Wait List Control Randomized Controlled Trial for College Students: Effects on Psychosocial Outcomes and Neural and Immune Processes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Psychosocial Functioning
Depression, Anxiety
Keywords: adolescents
mindfulness meditation
brain imaging
inflammation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility 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)

Primary outcomes:
measure: Psychological well-being
timeFrame: Baseline and at 8 weeks
measure: Depression
timeFrame: Baseline and at 8 weeks
measure: Anxiety
timeFrame: Baseline and at 8 weeks
measure: Perceived stress
timeFrame: Baseline and at 8 weeks
Secondary outcomes:
measure: Inflammation
timeFrame: Baseline and at 8 weeks
measure: Mindfulness
timeFrame: Baseline and at 8 weeks
measure: Positive and negative affect
timeFrame: Baseline and at 8 weeks
measure: Anhedonia
timeFrame: Baseline and at 8 weeks
measure: Loneliness
timeFrame: Baseline and at 8 weeks
measure: Rumination
timeFrame: Baseline and at 8 weeks
measure: Compassion for others
timeFrame: Baseline and at 8 weeks
measure: Sleep disruption (sleep latency, sleep duration, sleep efficiency, sleep disturbance and daytime dysfunction)
timeFrame: Baseline and at 8 weeks
measure: Savoring strategies
timeFrame: Baseline and at 8 weeks
measure: Self-concept
timeFrame: Baseline and at 8 weeks
measure: Self-compassion
timeFrame: Baseline and at 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Julienne E Bower, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: