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临床试验/NCT03402009
NCT03402009Unknown不适用

Assisting University Students Self-Manage Stress: Comparison of Mindfulness Meditation Tools

University of Connecticut2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
140
试验地点
2
主要终点
Change in Depression, Anxiety, and Stress Scales-21

研究概览

简要总结

The purpose of this study is to determine what tools best assist university students develop a personal meditation practice to self-manage stress. The two treatment conditions are 1) independent meditation using web-based tools and apps, and 2) independent meditation using web-based tools, apps and EEG-based neurofeedback. Outcomes of interest include acceptability, adherence, changes in mental health (i.e., anxiety, stress), physical health (i.e., sleep, inflammation), resilience, and level of commitment to further practice. Factors related to self-regulation (i.e., interoceptive awareness, self-esteem) will also be assessed as potential outcome moderators.

详细描述

Investigators will conduct a randomized controlled trial to evaluate strategies for assisting students develop a personal meditation practice. All participants will attend a mindfulness orientation, then begin the four-week intervention. During the intervention period, the treatment group will practice EEG-neurofeedback-assisted meditation using the Muse device (Interaxon) at least eight times over the four-week intervention period, and also practice mindfulness meditation on their own using their choice of tools (e.g., apps, weblinks, breath). The active control group will mirror the treatment group but will not have access to the EEG-neurofeedback device.

After a sufficient number of students register for the study who meet eligibility requirements, they will be provided with an option to enroll online in the first wave of the study, if their schedule allows, or be placed on a waitlist. Subsequent waves will take place throughout the semester(s) to accommodate additional participants. Enrolled participants will be asked to complete the pre-workshop questionnaire packet online, and attend an orientation session. During the orientation session, participants will first sign a consent form, provide a baseline saliva sample, then learn the basic technique of mindfulness meditation with an experienced meditation instructor. The orientation will also briefly explain the potential benefits of meditation from a scientific perspective, and emphasize the importance of establishing a daily practice, with the mindset that even one minute counts. Participants will then be asked to meditate for 3 minutes wearing the EEG device in order to get a baseline EEG reading. Following the orientation workshop, participants will be randomly assigned and notified via email into either the active control or treatment group along with group-specific instructions, and the 4-week intervention period will commence. Upon completion of the 4-week intervention, participants will be asked to complete post-intervention questionnaires online, then provide post-test measures of saliva, EEG reading during a 3 minute meditation. Participants will be debriefed, and those in the active control group will be given the option to use the EEG-neurofeedback. Follow-up surveys will be emailed to participants at 3, 6 and 12 months to examine if participants continue their meditation practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • English literate, undergraduates and graduate students attending UConn ages 18 and above (unless they are registered with the participant pool), who agree with the initial terms, are willing to learn basic skills of mindfulness meditation, agree to practice meditating with assigned tools independently and feel able to adhere to the time commitment required for the study. Participants must not currently have a regular seated meditation practice (regular, meaning at least 1x per week).

排除标准

  • participants unable to adhere to the commitment required for the study will be excluded

研究组 & 干预措施

Experimental

Experimental

independent meditation using web-based tools, apps, and EEG neurofeedback

干预措施: Apps (Behavioral)

Experimental

Experimental

independent meditation using web-based tools, apps, and EEG neurofeedback

干预措施: EEG neurofeedback (Behavioral)

Active Control

Active Comparator

independent meditation using web-based tools and apps

干预措施: Apps (Behavioral)

结局指标

主要结局

Change in Depression, Anxiety, and Stress Scales-21

时间窗: 5 weeks

(DASS-21; Lovibond \& Lovibond, 1995): an abbreviated, 21-item, Likert-style scale to assess levels of distress on three subscales: depression, anxiety and stress, based on how one felt over the past week. The DASS-21 has been used in prior studies assessing the benefits of mindfulness in undergraduate students (Gallego et al., 2014). It consists of 21 items with seven items per subscale, scored on a four-point scale ranging from 0 = did not apply to me at all to 3 = applied to me very much or most of the time. The total score sums all items. Higher scores indicate higher levels of distress.

次要结局

  • State-Trait Anxiety Inventory (STAI)(Baseline and 5 weeks)
  • Big Five personality(Baseline and 5 weeks)
  • MINDSENS (mindfulness)(Baseline and 5 weeks)
  • Experiences Questionnaire (decentering)(Baseline and 5 weeks)
  • Pittsburgh Sleep Quality Index(Baseline and 5 weeks)
  • Perceived Stress Scale-4 (PSS4)(Baseline and 5 weeks)
  • Connor-Davidson Resilience Scale (CD-RISC; Connor & Davidson, 2003)(Baseline and 5 weeks)
  • Self-Regulation of Eating Scale(Baseline and 5 weeks)
  • Multidimensional Assessment of Interoceptive Awareness (MAIA)(Baseline and 5 weeks)
  • Emotion Regulation Questionnaire (ERQ)(Baseline and 5 weeks)
  • Inflammatory cytokines (i.e., C-reactive protein, IL-6, and TNF-α)(Baseline and 5 weeks)
  • Rosenberg (1965) self-esteem scale (RSES)(Baseline and 5 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Blair Johnson

BoT Distinguished Professor of Psychological Sciences

University of Connecticut

研究点 (2)

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