Mindful Awareness Practices vs. Wait List Control Randomized Controlled Trial for College Students: Effects on Psychosocial Outcomes and Neural and Immune Processes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergraduate students at UCLA
- •Must live on the UCLA campus
- •Must be right-handed (for the fMRI scan)
排除标准
- •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)
结局指标
主要结局
Anxiety
时间窗: 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.
Psychological well-being
时间窗: 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.
Depression
时间窗: 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
Perceived stress
时间窗: 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.
次要结局
- Inflammation(Baseline and at 8 weeks)
- Loneliness(Baseline and at 8 weeks)
- Sleep disruption (sleep latency, sleep duration, sleep efficiency, sleep disturbance and daytime dysfunction)(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)
- Compassion for others(Baseline and at 8 weeks)
- Rumination(Baseline and at 8 weeks)
- Savoring strategies(Baseline and at 8 weeks)
- Self-concept(Baseline and at 8 weeks)
- Self-compassion(Baseline and at 8 weeks)
研究者
Julienne Bower, PhD
Associate Professor
University of California, Los Angeles