Predictors of Outcomes in MBSR Participants From Teacher Factors (Prompt-F)

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Behavioral: MBSR

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143-1726
      • Osher Center for Integrative Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 01545
      • Center for Mindfulness at University of Massachussets

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MBSR Teachers MBSR Participants MBI-TAC Raters

Description

Teachers

Inclusion Criteria:

• teaching MBSR in one of the study recruitment sites during the study period
• choose to participate

Exclusion:

• none

MBSR Participants

Inclusion Criteria:

• enrolled in MBSR class taught by an enrolled teacher
• choose to participate
• age 18 years or older

Exclusion:

• none

Raters

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.

Exclusion:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MBSR Students; community-dwelling adults who register for relevant MBSR courses at UMass CFM, UCSF, or participating community sites	Behavioral: MBSR; There is no study intervention per se, but participants will be teaching or enrolled in public 8-week MBSR classes.; Other Names: Mindfulness Based Stress Reduction
MBSR Teachers; those teaching MBSR courses at UMass CFM, UCSF, or participating community sites
Raters; experience mindfulness teachers, recruited by invitation, who will participate in MBI-TAC training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MBI-TAC inter-observer variability	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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rater agreement	Rater agreement	4 months
Rater test-retest reliability	Rater test-retest reliability	4 months
Distinguishing novice from experienced MBSR teachers	The difference in ratings of novice and experienced teachers with raters blinded to teacher experience will be examined. Comparison of mean scores will be performed using t-tests to compare mean scores between dichotomously grouped teachers (novice vs. experienced), and regression to test associations with ratings using experience as an ordinal variable (by grouped years of experience).	2 months
Participant rating of teachers	Iinternal consistency of the multiple items meant to measure each domain of teacher quality (e.g. coverage and pacing) using Cronbach's alpha. Scores on questions for each domain will be averaged to provide an overall score for the domain. ICC will be tested for each domain in a similar fashion to that described for the MBI:TAC; note that lower ICC values are anticipated on this instrument than the MBI:TAC, given the varied perspectives of different participants. Finally, the correlation of participant ratings of each domain (averaging ratings across participants) to ratings from the MBI:TAC.blinded to teacher experience will be tested. Comparison of mean scores will be performed using t-tests to compare mean scores between dichotomously grouped teachers (novice vs. experienced), and regression to test associations with ratings using experience as an ordinal variable (by grouped years of experience).	2 months
Patient Reported Outcome Measurement Information System (PROMIS-29) Fatigue scale	Higher scores indicate more fatigue (worse outcome). PROMIS-29 scales use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric, a score of 40 is one SD lower than the mean of the reference population, while score of 60 is one SD higher than the mean of the reference population. Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean = severe symptoms/impairment	2 months
Patient Reported Outcome Measurement Information System (PROMIS-29) Depression scale	Higher scores indicate more depression (worse outcome). PROMIS-29 scales use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric, a score of 40 is one SD lower than the mean of the reference population, while score of 60 is one SD higher than the mean of the reference population. Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean = severe symptoms/impairment	2 months
Patient Reported Outcome Measurement Information System (PROMIS-29) Sleep Disturbance scale	Higher scores indicate more Sleep Disturbance (worse outcome). PROMIS-29 scales use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric, a score of 40 is one SD lower than the mean of the reference population, while score of 60 is one SD higher than the mean of the reference population. Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean = severe symptoms/impairment	2 months
Patient Reported Outcome Measurement Information System (PROMIS-29) Physical Function scale	Higher scores indicate more Physical Function (better outcome). PROMIS-29 scales use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric, a score of 40 is one SD lower than the mean of the reference population, while score of 60 is one SD higher than the mean of the reference population. Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean = severe symptoms/impairment	2 months
Patient Reported Outcome Measurement Information System (PROMIS-29) Pain Interference scale	Higher scores indicate more Pain Interference (worse outcome). PROMIS-29 scales use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric, a score of 40 is one SD lower than the mean of the reference population, while score of 60 is one SD higher than the mean of the reference population. Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean = severe symptoms/impairment	2 months
Patient Reported Outcome Measurement Information System (PROMIS-29) Pain Intensity scale	Higher scores indicate more Pain Intensity (worse outcome). PROMIS-29 scales use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric, a score of 40 is one SD lower than the mean of the reference population, while score of 60 is one SD higher than the mean of the reference population. Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean = severe symptoms/impairment	2 months
Perceived Stress Scale-short	Stress appraisal, 4 items. Range: 0-16, higher scores indicate greater perceived stress (worse outcome).	2 months
Five Facet Mindfulness Questionnaire-short form (FFMQ-SF)	Mindfulness in five domains: observing, describing, acting with awareness, not judging inner experience, and not reacting to inner experience, 24 items Total score Range: 24-120, with higher scores indicating greater mindfulness (better outcome). Subscale Ranges: For describe, act with awareness, and non-judge, and non-react (all 5-item subscale): 5-25. For observe (4-items): 4-20. Higher scores indicate greater mindfulness (better outcome).	2 months
Positive Affect from the Positive and Negative Affect Scale (PANAS)	Intensity of positive emotions, 10 items.Range: 10-50, higher scores represent higher levels of positive affect (better outcome)	2 months
Negative Affect from the Positive and Negative Affect Scale (PANAS)	Intensity of negative emotions, 10 items. Range: 10-50, higher scores represent higher levels of negative affect (worse outcome)	2 months
Self-Compassion Scale (SCS-SF)	12 items. Range: 12-60, higher scores indicate greater self-compassion (better outcome).	2 months
Expected and Perceived benefit of MBSR	Participant expectations of and perceived benefit of the MBSR course, 5 items--Benefit overall, handling stress, managing mood/emotions, relationships, and physical health problems. Items can be summed to create total benefit score. Range: 0-50, with higher scores indicating greater benefits. Range for the individual items: 0-10, with higher scores indicating greater benefits (better outcome).	2 months
Study retention	Effects of video length and compensation factors on student retention in the study	2 months
Study enrollment	Effects of video length and compensation factors on enrollment into the study	0 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: mindfulness, MBSR, teaching
• Other Study ID Numbers: 1R34AT008948 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No