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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02419430
Other study ID # 15-001492
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 14, 2015
Last updated March 14, 2016
Start date April 2015
Est. completion date July 2016

Study information

Verified date March 2016
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date July 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion:

1. Stress subscale of the DASS-21 needs to be a score 5 or greater and

2. Must have a smart Phone, and

3. Ability to attend at least 5 complete sessions.

Exclusion :

1. Stress subscale of the DASS-21 less than 5.

2. Must have a smart Phone.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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: Joys of Life Count your blessings Think differenc, feel better Exercising --> Happier + Exercising --> Sleep Pre-Sleep routine Eat that frog Mindful Meditation
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.

Locations

Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in scores using the DASS-21(Depression Anxiety and Stress Scales) questionnaire Baseline to 6 months No
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