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临床试验/NCT03384771
NCT03384771已完成不适用

Predictors of Outcomes in MBSR Participants From Teacher Factors

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2017年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
219
试验地点
2
主要终点
MBI-TAC inter-observer variability

研究概览

简要总结

Objectives. The primary objective of the current proposal is to identify teacher-related factors that can be feasibly measured and shown to predict mindfulness-based intervention (MBI) participant outcomes. The secondary objective of this R34 proposal is to lay the groundwork for a large-scale R01-funded study in which the investigators anticipate studying participants in Mindfulness-Based Stress reduction (MBSR) courses provided by 50 or more teachers in a range of university- and community-based settings.

详细描述

Objectives. The primary objective of the current proposal is to identify teacher-related factors that can be feasibly measured and shown to predict mindfulness-based intervention (MBI) participant outcomes. The secondary objective of this R34 proposal is to lay the groundwork for a large-scale R01-funded study in which the investigators anticipate studying participants in Mindfulness-Based Stress reduction (MBSR) courses provided by 50 or more teachers in a range of university- and community-based settings. Design and Outcomes. This is an observational study of MBSR participants, teachers, and raters. Student participants will receive recruitment videos of different lengths and varying compensation schedules; The study will examine these to optimize participation and retention in the future R01 study.

Interventions and Duration. There is no study intervention per se, but participants will be teaching or enrolled in public 8-week MBSR classes. Outcome data will be collected from participants using internet-administered questionnaires at baseline, 2 months (immediate post-MBSR) and 4 months (post-MBSR follow-up). Rater study: The investigators will invite experience meditation teachers to be trained to use a the Mindfulness-Based Interventions Teaching Assessment Criteria (MBI-TAC) tool as a standardized approach to rating MBSR teacher competency. As part of the training, the study will be collecting data on how the training works. Thus, those who join the training will be asked to sign a consent form and complete a brief questionnaire about their teaching and meditation experience, as well as demographics; the study will also collect data on the ratings they do as part of the training. The goal of this part of the study is to assess the rater-training process.

Sample Size and Population. The study aims to enroll about 19 MBSR teachers and 200 MBSR participants, along with about 30 raters to be trained in the MBI-TAC system.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • teaching MBSR in one of the study recruitment sites during the study period
  • choose to participate
  • MBSR Participants
  • Inclusion Criteria:
  • enrolled in MBSR class taught by an enrolled teacher
  • choose to participate
  • age 18 years or older
  • Inclusion Criteria:
  • Certified to teach MBSR through the CFM's OASIS (or equivalent) training program.
  • 3+ years of MBSR teaching experience, having taught 10 MBSR classes.
  • 10+ years of personal mindfulness practice with daily practice and yearly retreat experience (on average 5+ days).
  • Have the interest and time available to complete web-based rater training and subsequent teacher ratings using an online interface, including in the Testing Phase.
  • Ideally will be able to attend at least 7/8 training dates.

排除标准

  • 未提供

结局指标

主要结局

MBI-TAC inter-observer variability

时间窗: 2 months

The key metric to be used to evaluate inter-observer variability is intraclass-correlation (ICC). 1 ICC provides a measure of how strongly ratings of the same item by different raters resemble each other, with values ranging from 0 (only random agreement) to 1 (perfect agreement). ICC will be calculated for each of the six domains in MBI:TAC, as well as the summary score.

次要结局

  • Study retention(2 months)
  • Rater test-retest reliability(4 months)
  • Participant rating of teachers(2 months)
  • Patient Reported Outcome Measurement Information System (PROMIS-29) Sleep Disturbance scale(2 months)
  • Distinguishing novice from experienced MBSR teachers(2 months)
  • Rater agreement(4 months)
  • Patient Reported Outcome Measurement Information System (PROMIS-29) Fatigue scale(2 months)
  • Positive Affect from the Positive and Negative Affect Scale (PANAS)(2 months)
  • Negative Affect from the Positive and Negative Affect Scale (PANAS)(2 months)
  • Patient Reported Outcome Measurement Information System (PROMIS-29) Depression scale(2 months)
  • Patient Reported Outcome Measurement Information System (PROMIS-29) Pain Interference scale(2 months)
  • Patient Reported Outcome Measurement Information System (PROMIS-29) Pain Intensity scale(2 months)
  • Perceived Stress Scale-short(2 months)
  • Self-Compassion Scale (SCS-SF)(2 months)
  • Expected and Perceived benefit of MBSR(2 months)
  • Patient Reported Outcome Measurement Information System (PROMIS-29) Physical Function scale(2 months)
  • Five Facet Mindfulness Questionnaire-short form (FFMQ-SF)(2 months)
  • Study enrollment(0 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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