StressNCT02366078
Stress Management Training for School Staff
A study testing SMART in people with Stress, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- SMART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Public school teacher
- Able tor read English
Who cannot join
- Unable to read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Efficacy of Using Blended Learning With the Stress Management and Resilience Training (SMART) Program to Decrease Stress and Enhance Resilience in Public School Staff
The purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated.
Read the detailed description
The purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated.
This study builds on previous work in other working populations with high stress levels inherent in the specific work process.
- Conditions
- Stress
- Being tested
- SMART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTBehavioural
Paced breathing meditation with cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Stress management | Experimental | Participants will receive SMART traiing Receives: Behavioral: SMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported stress level
Linear analogue scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent A. Bauer, Mayo Clinic
- Investigators
- Brent Bauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366078
- Sponsor's protocol ID
- 14-005976
- Status last verified
- Mar 2017
- First submitted
- 11 Feb 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Using Blended Learning With the Stress Management and Resilience Training (SMART) Program to Decrease Stress and Enhance Resilience in Public School Staff
- ClinicalTrials.gov ID
- NCT02366078
- Acronym / sponsor ID
- 14-005976
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Feb 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 purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated.
Detailed description
The purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated.
This study builds on previous work in other working populations with high stress levels inherent in the specific work process.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress management | Experimental | Behavioral: SMARTParticipants will receive SMART traiing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Public school teacher
- Able tor read English
Key exclusion criteria (1 listed)
- Unable to read English
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 |
|---|---|---|
| SMARTPaced breathing meditation with cognitive training | Behavioural | Stress management |
Primary outcome
Self reported stress level
Time frame: 1 year
Linear analogue scale
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 27 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Brent Bauer, 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 SMART in people with Stress, 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 2 inclusion and 1 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 27 Mar 2017. 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?
Self reported stress level (time frame: 1 year). 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 27 Mar 2017.