Mindfulness Meditation Neuroimaging Study for Undergraduates

NCT05304052 | Completed

• 1 other identifier: 21-002038
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammation; Psychosocial Functioning; Depression, Anxiety

Keywords

adolescents; mindfulness meditation; brain imaging; inflammation

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and at 8 weeks

• 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

  Baseline and at 8 weeks

• 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.

  Baseline and at 8 weeks

• 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.

  Baseline and at 8 weeks

Secondary Outcomes (11)

• Inflammation

  Baseline and at 8 weeks

• Mindfulness

  Baseline and at 8 weeks

• Positive and negative affect

  Baseline and at 8 weeks

• Anhedonia

  Baseline and at 8 weeks

• Loneliness

  Baseline and at 8 weeks

Study Arms (2)

Mindfulness meditation intervention

EXPERIMENTAL

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

Wait list control

NO INTERVENTION

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.

Interventions

Mindfulness Meditation classes BEHAVIORAL

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.

Mindfulness meditation intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Inflammation; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Julienne E Bower, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 31, 2022
• Study Start: March 27, 2022
• Primary Completion: June 10, 2023
• Study Completion: June 10, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)