NCT02419430

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

April 14, 2015

Last Update Submit

May 14, 2016

Conditions

Keywords

well-beingstressresilienceself-compassion

Outcome Measures

Primary Outcomes (1)

  • Changes in scores using the DASS-21(Depression Anxiety and Stress Scales) questionnaire

    Baseline to 6 months

Study Arms (3)

MBRT ClassRoom and Phone Application

ACTIVE COMPARATOR

MBRT ClassRoom and Phone Application

Behavioral: MBRT ClassRoom and Phone Application

Phone application only

ACTIVE COMPARATOR

Phone application only

Behavioral: Phone application only

Questionnaires

ACTIVE COMPARATOR

Questionnaires

Behavioral: Questionnaires

Interventions

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.

MBRT ClassRoom and Phone Application

Participants will track their sleep and subjective well-being and also choose one of the following weekly challenges, which is completed via smartphone interactions: * Joys of Life * Count your blessings * Think differenc, feel better * Exercising --\> Happier \+ Exercising --\> Sleep * Pre-Sleep routine * Eat that frog * Mindful Meditation

Phone application only
QuestionnairesBEHAVIORAL

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.

Questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Stress subscale of the DASS-21 less than 5.
  • Must have a smart Phone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Cynthia Stonnington, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 17, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations