NCT03510117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

5.1 years

First QC Date

April 16, 2018

Last Update Submit

June 12, 2023

Conditions

Mindfulness

Keywords

MindfulnessPatient reported outcomes measuresPROMIS

Outcome Measures

Primary Outcomes (1)

  • Mindfulness Questionnaire

    Mindfulness Questionnaire

    DAY 0

Study Arms (1)

Mindfulness

OTHER

Mindfulness

Behavioral: Mindfulness

Interventions

MindfulnessBEHAVIORAL

Mindfulness

Mindfulness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (135)

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MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • David E Victorson, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 27, 2018

Study Start

July 1, 2017

Primary Completion

July 26, 2022

Study Completion

July 26, 2022

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)