COMMENCE: Creating and Optimizing Mindfulness Measures to Enhance and Normalize Clinical Evaluation

Sponsor

Northwestern University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03510117

Collaborator

National Institutes of Health (NIH) (NIH), University of Pittsburgh (Other), National Center for Complementary and Integrative Health (NCCIH) (NIH)

5,098

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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.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 :

Jul 1, 2017

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Mindfulness Mindfulness	Behavioral: Mindfulness Mindfulness

Arm

Intervention/Treatment

Other: Mindfulness

Mindfulness

Behavioral: Mindfulness

Mindfulness

Outcome Measures

Primary Outcome Measures

Mindfulness Questionnaire [DAY 0]
Mindfulness Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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)

Exclusion Criteria:

Unable to provide consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: David E Victorson, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

David Victorson, Associate Professor, Northwestern University

ClinicalTrials.gov Identifier:

NCT03510117

Other Study ID Numbers:

STU00205373
1R01AT009539-01

First Posted:

Apr 27, 2018

Last Update Posted:

Oct 6, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by David Victorson, Associate Professor, Northwestern University

Mindfulness

Patient reported outcomes measures

PROMIS

Study Results

No Results Posted as of Oct 6, 2021