NCT03384771

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

January 11, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2020

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

June 11, 2017

Last Update Submit

July 2, 2024

Conditions

Healthy

Keywords

mindfulness, MBSR, teaching

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Rater agreement

    4 months

  • Rater test-retest reliability

    4 months

  • Distinguishing novice from experienced MBSR teachers

    2 months

  • Participant rating of teachers

    2 months

  • Patient Reported Outcome Measurement Information System (PROMIS-29) Fatigue scale

    2 months

  • +13 more secondary outcomes

Study Arms (3)

MBSR Students

community-dwelling adults who register for relevant MBSR courses at University of Massachusetts Center for Mindfulness (UMass CFM), University of California San Francisco (UCSF), or participating community sites

Behavioral: MBSR

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

Interventions

MBSRBEHAVIORAL

There is no study intervention per se, but participants will be teaching or enrolled in public 8-week MBSR classes.

Also known as: Mindfulness Based Stress Reduction
MBSR Students

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MBSR Teachers MBSR Participants MBI-TAC Raters

You may qualify if:

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

You may not qualify if:

  • none
  • MBSR Participants
  • enrolled in MBSR class taught by an enrolled teacher
  • choose to participate
  • age 18 years or older
  • none
  • Raters
  • Certified to teach MBSR through the CFM's OASIS (or equivalent) training program.
  • + years of MBSR teaching experience, having taught 10 MBSR classes.
  • + 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.
  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Osher Center for Integrative Medicine

San Francisco, California, 94143-1726, United States

Location

Center for Mindfulness at University of Massachussets

Boston, Massachusetts, 01545, United States

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2017

First Posted

December 27, 2017

Study Start

January 11, 2017

Primary Completion

January 26, 2020

Study Completion

January 26, 2020

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

US(2)