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

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ClinicalTrials.gov Identifier: NCT03510117
Recruitment Status : Enrolling by invitation
First Posted : April 27, 2018
Last Update Posted : September 3, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Pittsburgh
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
David Victorson, Northwestern University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mindfulness Behavioral: Mindfulness Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5098 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: To evaluate different forms of validity (e.g., construct, criterion), responsiveness to change over time, and estimation of minimally important differences, we will administer new mindfulness short forms, legacy measures, and an experiential measure of focused attention 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Creating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical Evaluation (COMMENCE)
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Mindfulness
Mindfulness
Behavioral: Mindfulness
Mindfulness




Primary Outcome Measures :
  1. Mindfulness Questionnaire [ Time Frame: DAY 0 ]
    Mindfulness Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be at least 18 years of age
  • Must be able to speak and understand English
  • Must be participating in an ongoing mindfulness-based intervention taking place in practice-based research network collaborating sites (e.g., Bravenet, Academic Consortium for Integrative Medicine and Health) as well as local networks at Pittsburgh and Chicago sites

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510117


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Northwestern University
National Institutes of Health (NIH)
University of Pittsburgh
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: David E Victorson, PhD Northwestern University
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Responsible Party: David Victorson, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03510117    
Other Study ID Numbers: STU00205373
1R01AT009539-01 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Victorson, Northwestern University:
Mindfulness
Patient reported outcomes measures
PROMIS