- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02419430
Mindfulness Based Resilience Training (MBRT)
May 14, 2016 updated by: Cynthia M. Stonnington, M.D., Mayo Clinic
Mindfulness Based Resilience Training for Employees at Mayo Clinic
The investigators aim to evaluate the Mindfulness Based Resilience Training (MBRT) intervention for Mayo Clinic employees in order to provide evidence for improved ability to cope with stress and decreased work-related burnout and stress-related symptoms as a result of MBRT training.
In addition, the investigators aim to compare the effects of MBRT + smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback, or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of 75 Mayo Clinic employees.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators aim to compare the effects of MBRT + smartphone sleep feedback, a smartphone resilience intervention + smartphone sleep feedback, or waitlist control +smartphone sleep feedback in a randomized clinical trial in a sample of 75 Mayo Clinic employees.
Specific self-report outcomes include: well-being, stress, anxiety, depression, fatigue, resilience, self-compassion, and burn-out, assessed at pre-, post- and 3-month followup.
Objective outcomes, derived from smartphone-driven self-monitoring, include sleep quality and emotional experiencing, assessed throughout the six-week intervention period.
The investigators will explore whether changes in objectively measured sleep quality and emotional experiencing will mediate treatment effects on self-report outcomes.
The investigators will also explore whether treatment effects are more robust in self-selected versus randomized groups by drawing on the investigators' existing data.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion:
- Stress subscale of the DASS-21 needs to be a score 5 or greater and
- Must have a smart Phone, and
- Ability to attend at least 5 complete sessions.
Exclusion :
- Stress subscale of the DASS-21 less than 5.
- Must have a smart Phone.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: MBRT ClassRoom and Phone Application
|
2 hours/week for 6 week, in classroom intervention involving mindfulness based resilience training.focused
on mindfulness and self-compassion training, including body awareness, breath awareness, mindful movement, awareness of thoughts, and awareness of emotion.
Core concepts included: normalizing experience of stress and changing one's relationship with an experience; learning to be a compassionate observer of self in order to appreciate the moment; recognizing undue efforts to control something that has already happened; shifting attention to felt body sense and away from the narrative; and redirecting attention to a value as a way of evoking positive states that enhance the present moment experience.
Participants also use the smartphone to track their sleep and subjective well-being.
|
Active Comparator: Phone application only
|
Participants will track their sleep and subjective well-being and also choose one of the following weekly challenges, which is completed via smartphone interactions:
|
Active Comparator: Questionnaires
|
At baseline, immediately after the last MBRT session (6 weeks) and again at 3 and 6 months, all participants will complete questionnaires, including: 1) WHO-5 Well-Being Index; 2) DASS-21; 3) VAS-Fatigue; 4) MBI-Human Services version; 5) Self-Compassion Scale; 6) Connor-Davidson 2-item resilience scale; 7) Compassion to others scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in scores using the DASS-21(Depression Anxiety and Stress Scales) questionnaire
Time Frame: Baseline to 6 months
|
Baseline to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
April 14, 2015
First Submitted That Met QC Criteria
April 16, 2015
First Posted (Estimate)
April 17, 2015
Study Record Updates
Last Update Posted (Estimate)
May 17, 2016
Last Update Submitted That Met QC Criteria
May 14, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-001492
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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