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Completed

NCT Number: NCT03384771

Predictors of Outcomes in MBSR Participants From Teacher Factors

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Osher Center for Integrative Medicine, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBSR

Behavioral

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

Primary outcomes

  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 outcomes

  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

    Internal 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • University of Massachusetts, Worcester

Registry information

Acronym: Prompt-F

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 27, 2017
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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