Stress, PsychologicalMBRTNCT02419430
Mindfulness Based Resilience Training
A study testing MBRT ClassRoom and Phone Application, Phone application only and Questionnaires in people with Stress, Psychological, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- MBRT ClassRoom and Phone Application, Phone application only and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Stress subscale of the DASS-21 less than 5.
- Must have a smart Phone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- MBRT ClassRoom and Phone Application, Phone application only, Questionnaires
- Keywords
- well-being, stress, resilience, self-compassion
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBRT ClassRoom and Phone ApplicationBehavioural
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 onlyBehavioural
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
QuestionnairesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBRT ClassRoom and Phone Application | Active comparator | MBRT ClassRoom and Phone Application Receives: Behavioral: MBRT ClassRoom and Phone Application |
| Phone application only | Active comparator | Phone application only Receives: Behavioral: Phone application only |
| Questionnaires | Active comparator | Questionnaires Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in scores using the DASS-21(Depression Anxiety and Stress Scales) questionnaire
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Cynthia M. Stonnington, M.D., Mayo Clinic
- Investigators
- Cynthia Stonnington, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419430
- Sponsor's protocol ID
- 15-001492
- Acronym
- MBRT
- Status last verified
- May 2016
- First submitted
- 14 Apr 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Resilience Training for Employees at Mayo Clinic
- ClinicalTrials.gov ID
- NCT02419430
- Acronym / sponsor ID
- MBRT / 15-001492
- Conditions
- Stress, Psychological
- Keywords
- well-being, stress, resilience, self-compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBRT ClassRoom and Phone Application | Active comparator | Behavioral: MBRT ClassRoom and Phone ApplicationMBRT ClassRoom and Phone Application |
| Phone application only | Active comparator | Behavioral: Phone application onlyPhone application only |
| Questionnaires | Active comparator | Behavioral: QuestionnairesQuestionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Stress subscale of the DASS-21 less than 5.
- Must have a smart Phone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBRT ClassRoom and Phone Application2 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. | Behavioural | MBRT ClassRoom and Phone Application |
| Phone application onlyParticipants 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 | Behavioural | Phone application only |
| QuestionnairesAt 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. | Behavioural | Questionnaires |
Primary outcome
Changes in scores using the DASS-21(Depression Anxiety and Stress Scales) questionnaire
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Stonnington, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBRT ClassRoom and Phone Application, Phone application only and Questionnaires in people with Stress, Psychological, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in scores using the DASS-21(Depression Anxiety and Stress Scales) questionnaire (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.