跳至主要内容
临床试验/NCT03510117
NCT03510117已完成不适用

Creating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical Evaluation (COMMENCE)

Northwestern University2 个研究点 分布在 1 个国家目标入组 8,152 人开始时间: 2017年7月1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
8,152
试验地点
2
主要终点
Mindfulness Questionnaire

研究概览

简要总结

While MBI trials have reached a greater level of rigor (e.g., random assignment, matching on time, attention, teacher characteristics, non-specific factors) a significant gap still remains in mindfulness research: the lack of a comprehensive and standardized self-report measurement system. A precise, carefully constructed set of assessment tools based on a common measurement system are needed; where scores can be psychometrically linked to current "legacy" measures to better understand the existing body of mindfulness research. In this study, Creating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical Evaluation (COMMENCE), the investigators will use Patient Reported Outcomes Measurement Information System (PROMIS) methodologies to construct improved self-report mindfulness-related measures. They will also use PROMIS-based PROsetta Stone linking methods to equate scores and create cross-walks between new mindfulness measures and existing ones.

详细描述

The investigators will use Patient Reported Outcomes Measurement Information System (PROMIS®) methodologies to construct improved self-report mindfulness-related measures. They will also use PROMIS-based PROsetta Stone® instrument linking methods to equate scores and create cross-walks between new mindfulness measures and existing ones. The research team has extensive experience in patient reported outcomes (PRO) development through PROMIS and related PRO development initiatives, including mind-body measures (Chicago and Pittsburgh), PROsetta Stone linking methodologies (Chicago), and mindfulness research (Pittsburgh and Chicago).

PROMIS methodologies involve a systematic and iterative approach to person-centered measurement and are the gold standard. Following PROMIS methods, newly created mindfulness measures will be informed by: 1) the existing literature, and 2) stakeholders such as mindfulness researchers, Buddhist and MBI teachers, and new and experienced meditators. COMMENCE analyses will also reflect PROMIS, producing concise, precise, clinically relevant measures that can be administered as Computerized Adaptive Tests (CATs) or fixed-length short forms. PROsetta Stone methods will enable a crosswalk between the new mindfulness measures and legacy instruments that assess similar constructs. All of this will have a major impact on mindfulness research through increasing measurement precision and comparability across and between studies: past, present, and future. The project will also address the response shift challenge. New mindfulness measures and crosswalk linking will be produced through the following three SPECIFIC AIMS:

SPECIFIC AIM I. Development of New Mindfulness Item Banks. Activities include: 1) a review of the mindfulness measurement literature; 2) an online survey of mindfulness researchers to identify domains and measurement considerations for item bank development; 3) focus groups with new and experienced meditators, and individual interviews with mindfulness meditation practitioners, including Buddhist teachers, to elaborate on concepts such as response shift; 4) item refinement; 6) translatability review; and 7) cognitive interviews to assess item clarity.

SPECIFIC AIM II. Calibration of New Mindfulness Item Banks and Score Linking with Legacy Measures. Calibration activities will include: 1) testing new mindfulness item banks in a large online general population sample (n=4200) and a sample of mindfulness teachers and students (n=500); 2) evaluation of dimensionality and other assumptions prior to Item Response Theory (IRT) analysis; 3) IRT analyses; and 4) creation of CATs and fixed length short forms. A battery of legacy measures will also be administrated alongside new mindfulness banks. Using PROsetta Stone procedures, the investigators will test mindfulness banks and legacy measures in a new large online sample (n=3000) to link measures on a common measurement metric and create cross-walk scoring tables to facilitate interpretation.

SPECIFIC AIM III. Validation of New Mindfulness Short Forms in Ongoing Mindfulness Courses. To evaluate different forms of validity (e.g., construct, criterion), responsiveness to change over time, and estimation of minimally important differences, the investigators will administer new mindfulness short forms and legacy measures to 250 mindfulness students at baseline, 8-weeks, and 16 weeks in multiple, on-going 8-week Mindfulness-Based Stress Reduction (MBSR) courses and similar MBI programs at Pittsburgh and Chicago sites, as well as at member sites from the Academic Consortium for Integrative Medicine and Health and the BraveNet Practice-Based Research Network. In addition to legacy measures, a subset of the sample will complete the meditation breath awareness score, an experiential measure of focused attention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Must be at least 18 years of age
  • Must be able to speak and understand English
  • Must be enrolled in an multi-week, group-based, instructor-led, live (in-person or online) mindfulness-based program that has not yet started (i.e., before session 1)

排除标准

  • Unable to provide consent

结局指标

主要结局

Mindfulness Questionnaire

时间窗: DAY 0

Mindfulness Questionnaire

次要结局

未报告次要终点

研究者

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

David Victorson

Associate Professor

Northwestern University

研究点 (2)

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