Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03384771
Recruitment Status : Enrolling by invitation
First Posted : December 27, 2017
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Rick Hecht, University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment
Healthy 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Predictors of Outcomes in MBSR Participants From Teacher Factors
Study Start Date : January 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

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 Name: 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



Primary Outcome Measures :
  1. MBI-TAC inter-observer variability [ Time Frame: 2 months ]
    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.


Secondary Outcome Measures :
  1. Rater agreement [ Time Frame: 4 months ]
    Rater agreement

  2. Rater test-retest reliability [ Time Frame: 4 months ]
    Rater test-retest reliability

  3. Distinguishing novice from experienced MBSR teachers [ Time Frame: 2 months ]
    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).

  4. Participant rating of teachers [ Time Frame: 2 months ]
    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).

  5. Patient Reported Outcome Measurement Information System (PROMIS-29) Fatigue scale [ Time Frame: 2 months ]
    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

  6. Patient Reported Outcome Measurement Information System (PROMIS-29) Depression scale [ Time Frame: 2 months ]
    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

  7. Patient Reported Outcome Measurement Information System (PROMIS-29) Sleep Disturbance scale [ Time Frame: 2 months ]
    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

  8. Patient Reported Outcome Measurement Information System (PROMIS-29) Physical Function scale [ Time Frame: 2 months ]
    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

  9. Patient Reported Outcome Measurement Information System (PROMIS-29) Pain Interference scale [ Time Frame: 2 months ]
    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

  10. Patient Reported Outcome Measurement Information System (PROMIS-29) Pain Intensity scale [ Time Frame: 2 months ]
    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

  11. Perceived Stress Scale-short [ Time Frame: 2 months ]
    Stress appraisal, 4 items. Range: 0-16, higher scores indicate greater perceived stress (worse outcome).

  12. Five Facet Mindfulness Questionnaire-short form (FFMQ-SF) [ Time Frame: 2 months ]

    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).


  13. Positive Affect from the Positive and Negative Affect Scale (PANAS) [ Time Frame: 2 months ]
    Intensity of positive emotions, 10 items.Range: 10-50, higher scores represent higher levels of positive affect (better outcome)

  14. Negative Affect from the Positive and Negative Affect Scale (PANAS) [ Time Frame: 2 months ]
    Intensity of negative emotions, 10 items. Range: 10-50, higher scores represent higher levels of negative affect (worse outcome)

  15. Self-Compassion Scale (SCS-SF) [ Time Frame: 2 months ]
    12 items. Range: 12-60, higher scores indicate greater self-compassion (better outcome).

  16. Expected and Perceived benefit of MBSR [ Time Frame: 2 months ]
    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).

  17. Study retention [ Time Frame: 2 months ]
    Effects of video length and compensation factors on student retention in the study

  18. Study enrollment [ Time Frame: 0 months ]
    Effects of video length and compensation factors on enrollment into the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
MBSR Teachers MBSR Participants MBI-TAC Raters
Criteria

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


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): NCT03384771


Locations
Layout table for location information
United States, California
Osher Center for Integrative Medicine
San Francisco, California, United States, 94143-1726
United States, Massachusetts
Center for Mindfulness at University of Massachussets
Boston, Massachusetts, United States, 01545
Sponsors and Collaborators
University of California, San Francisco
University of Massachusetts, Worcester

Layout table for additonal information
Responsible Party: Rick Hecht, PI, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03384771     History of Changes
Other Study ID Numbers: 1R34AT008948 ( U.S. NIH Grant/Contract )
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rick Hecht, University of California, San Francisco:
mindfulness, MBSR, teaching