Clinical trial NCT03384771: Predictors of Outcomes in MBSR Participants From Teacher Factors
Official title: Predictors of Outcomes in MBSR Participants From Teacher Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: mindfulness, MBSR, teaching
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2017-12-27
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MBSR Teachers MBSR Participants MBI-TAC Raters

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.

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.

Eligibility 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

Primary outcomes:
measure: MBI-TAC inter-observer variability
timeFrame: 2 months
Secondary outcomes:
measure: Rater agreement
timeFrame: 4 months
measure: Rater test-retest reliability
timeFrame: 4 months
measure: Distinguishing novice from experienced MBSR teachers
timeFrame: 2 months
measure: Participant rating of teachers
timeFrame: 2 months
measure: Patient Reported Outcome Measurement Information System (PROMIS-29) Fatigue scale
timeFrame: 2 months
measure: Patient Reported Outcome Measurement Information System (PROMIS-29) Depression scale
timeFrame: 2 months
measure: Patient Reported Outcome Measurement Information System (PROMIS-29) Sleep Disturbance scale
timeFrame: 2 months
measure: Patient Reported Outcome Measurement Information System (PROMIS-29) Physical Function scale
timeFrame: 2 months
measure: Patient Reported Outcome Measurement Information System (PROMIS-29) Pain Interference scale
timeFrame: 2 months
measure: Patient Reported Outcome Measurement Information System (PROMIS-29) Pain Intensity scale
timeFrame: 2 months
measure: Perceived Stress Scale-short
timeFrame: 2 months
measure: Five Facet Mindfulness Questionnaire-short form (FFMQ-SF)
timeFrame: 2 months
measure: Positive Affect from the Positive and Negative Affect Scale (PANAS)
timeFrame: 2 months
measure: Negative Affect from the Positive and Negative Affect Scale (PANAS)
timeFrame: 2 months
measure: Self-Compassion Scale (SCS-SF)
timeFrame: 2 months
measure: Expected and Perceived benefit of MBSR
timeFrame: 2 months
measure: Study retention
timeFrame: 2 months
measure: Study enrollment
timeFrame: 0 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine
state: California
city: Boston
country: United States
facility: Center for Mindfulness at University of Massachussets
state: Massachusetts
Study officials:
References: