StressEarly Phase 1MTSNCT01082497
Mindfulness Training for Staff (MTS)
A Early Phase 1 study testing Mindfulness training in people with Stress, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The purpose of this study is to investigate whether a mindfulness based 8-week course for stress reduction, known as MBSR course, given to all staff at an inpatient psychiatric ward influences the level of stress and burnout and the psychosocial atmosphere at the ward. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteNorway
- Study dates
- May 2009to Jan 2011
- Phase
- Early Phase 1
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all staff working at the ward 50 % or more, not attending to leave during the first year.
Who cannot join
- Staff working less than 50%, planned to leave before one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Training and Developing the Ability of Empathy at an Inpatient Ward for Dual Diagnoses
The purpose of this study is to investigate whether a mindfulness based 8-week course for stress reduction, known as MBSR course, given to all staff at an inpatient psychiatric ward influences the level of stress and burnout and the psychosocial atmosphere at the ward.
The design is an intervention trial with repeated measures and control group.The focus is the interaction between unit and individuals.
Read more
All staff at both wards were invited to participate. The intervention consists of 8 weekly group meetings where the participants learn different ways of practicing mindfulness and do home practice between the meetings. The control intervention is 8 weekly workshops in affect-consciousness.
Data are collected through self-reporting questionnaires on mindfulness, work- and health-related topics at six different points. The patients at both wards answers one questionnaire about ward atmosphere at the same points.
Data wil be analyzed on SPSS statistic programme.
Read the detailed description
MBSR for staff in inpatient psychiatric units
The challenges for staff working at an inpatient unit for psychotic people are many, and still more where the patients also have addiction problems. The patients are seriously ill and in need of extensive support and treatment. It is needed for the staff to be continuously aware and present, stand all kind of situations and hold out (contain) a lot of critique and threatening from the patients. Often they are too exhausted to take care of themselves and their own stress. The risk for burnout is high. The purpose of this study is to investigate whether a mindfulness based 8-week course for stress reduction, known as MBSR course, given to all staff at an inpatient psychiatric ward influences the psychosocial atmosphere at the ward.
The design of the study is an intervention trial with repeated measures and control group. The intervention consists of 8 weekly group meetings where the participants learn different ways of practicing mindfulness; sitting, walking, yoga exercises,and body scan.They are asked to practice between the group-meetings and get a workbook and cds as support.
This is a prospective intervention study with control group and repeated measures over one year follow up. The focus is the interaction between unit and individuals.
To more closely study the specific effect of mindfulness practice the control group receive an active intervention which has similarities to mindfulness practice: workshops in affect - consciousness of same amount as the MBSR-course.
All staff at the research unit and the control unit were invited to participate, each group has a number of 25 - 30 individuals. Data are collected through self-reporting questionnaires at six different points. The patients answers one questionnaire at the same points.
The inventories chosen are:
Demographics Quality of life Subjective health complains Five Facets Mindfulness Questioner (Baer) Maslach Burnout Inventory Work satisfaction Total Work load - short form Ward-atmosphere scale (also for the patients) Sick leave and number of registered harm /injury- episodes will be taken on 3 -4 points.
Hopefully this study will show that when the staff practice mindfulness this will bring about a more relaxed and accepting atmosphere followed by lesser exhaustion and anxiety. Consequences should be that mindfulness practise becomes more ordinary in psychiatric hospital wards.
- Conditions
- Stress
- Being tested
- Mindfulness training
- Keywords
- Mindfulness, Stress, Burnout, Ward atmosphere, Stress and burnout among staff, psychosocial atmosphere at the ward
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
Also called MBSR
A course in mindfulness based stress reduction with 8 weekly group meetings and home practice between the meetings. Each meetings last for 90 minutes. Participants get workbook and cds to support home practice.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Not described Receives: Behavioral: Mindfulness training |
| Education | Active comparator | 8 - weekly workshops on affect consciousness for all staff Receives: Behavioral: Mindfulness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of mindfulness measured by the Five Facet Mindfulness Questionnaire
The questionnaire measure the ability to observe, describe and act with awareness,nonreactivity and non-judgemental awareness.
Measured: Three months before to one year follow up after the intervention
Secondary outcomes (1)
The amount of work stress and burnout measured with The Maslach Burnout Inventory
The questionnaire measure the dimentions emotional exchaustion,depersonalization and persomal accomplishment.
Measured: Three months before intervention to one year follow up after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startMay 2009
- Primary completionJan 2010
- Study completionJan 2011
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.
- 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tordis Sorensen Hoifodt, dr med. phd, Study chair, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082497
- Sponsor's protocol ID
- P REK NORD-134/2008
- Acronym
- MTS
- Status last verified
- Apr 2012
- First submitted
- 5 Mar 2010
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training and Developing the Ability of Empathy at an Inpatient Ward for Dual Diagnoses
- ClinicalTrials.gov ID
- NCT01082497
- Acronym / sponsor ID
- MTS / P REK NORD-134/2008
- Conditions
- Stress
- Keywords
- Mindfulness, Stress, Burnout, Ward atmosphere, Stress and burnout among staff, psychosocial atmosphere at the ward
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Mar 2010 (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 whether a mindfulness based 8-week course for stress reduction, known as MBSR course, given to all staff at an inpatient psychiatric ward influences the level of stress and burnout and the psychosocial atmosphere at the ward.
The design is an intervention trial with repeated measures and control group.The focus is the interaction between unit and individuals.
All staff at both wards were invited to participate. The intervention consists of 8 weekly group meetings where the participants learn different ways of practicing mindfulness and do home practice between the meetings. The control intervention is 8 weekly workshops in affect-consciousness.
Data are collected through self-reporting questionnaires on mindfulness, work- and health-related topics at six different points. The patients at both wards answers one questionnaire about ward atmosphere at the same points.
Data wil be analyzed on SPSS statistic programme.
Detailed description
MBSR for staff in inpatient psychiatric units
The challenges for staff working at an inpatient unit for psychotic people are many, and still more where the patients also have addiction problems. The patients are seriously ill and in need of extensive support and treatment. It is needed for the staff to be continuously aware and present, stand all kind of situations and hold out (contain) a lot of critique and threatening from the patients. Often they are too exhausted to take care of themselves and their own stress. The risk for burnout is high. The purpose of this study is to investigate whether a mindfulness based 8-week course for stress reduction, known as MBSR course, given to all staff at an inpatient psychiatric ward influences the psychosocial atmosphere at the ward.
The design of the study is an intervention trial with repeated measures and control group. The intervention consists of 8 weekly group meetings where the participants learn different ways of practicing mindfulness; sitting, walking, yoga exercises,and body scan.They are asked to practice between the group-meetings and get a workbook and cds as support.
This is a prospective intervention study with control group and repeated measures over one year follow up. The focus is the interaction between unit and individuals.
To more closely study the specific effect of mindfulness practice the control group receive an active intervention which has similarities to mindfulness practice: workshops in affect - consciousness of same amount as the MBSR-course.
All staff at the research unit and the control unit were invited to participate, each group has a number of 25 - 30 individuals. Data are collected through self-reporting questionnaires at six different points. The patients answers one questionnaire at the same points.
The inventories chosen are:
Demographics Quality of life Subjective health complains Five Facets Mindfulness Questioner (Baer) Maslach Burnout Inventory Work satisfaction Total Work load - short form Ward-atmosphere scale (also for the patients) Sick leave and number of registered harm /injury- episodes will be taken on 3 -4 points.
Hopefully this study will show that when the staff practice mindfulness this will bring about a more relaxed and accepting atmosphere followed by lesser exhaustion and anxiety. Consequences should be that mindfulness practise becomes more ordinary in psychiatric hospital wards.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness training |
| Education | Active comparator | Behavioral: Mindfulness training8 - weekly workshops on affect consciousness for all staff |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all staff working at the ward 50 % or more, not attending to leave during the first year.
Key exclusion criteria (1 listed)
- Staff working less than 50%, planned to leave before one year.
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 |
|---|---|---|
| Mindfulness trainingAlso: MBSRA course in mindfulness based stress reduction with 8 weekly group meetings and home practice between the meetings. Each meetings last for 90 minutes. Participants get workbook and cds to support home practice. | Behavioural | Education, Mindfulness |
Primary outcome
The ability of mindfulness measured by the Five Facet Mindfulness Questionnaire
Time frame: Three months before to one year follow up after the intervention
The questionnaire measure the ability to observe, describe and act with awareness,nonreactivity and non-judgemental awareness.
1 secondary outcome
The amount of work stress and burnout measured with The Maslach Burnout Inventory
Time frame: Three months before intervention to one year follow up after the intervention
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 12 Apr 2012.
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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.
Tordis Sorensen Hoifodt, dr med. phd study chair
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mindfulness training in people with Stress, run by University Hospital of North Norway at 1 site in Norway.
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 1 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 12 Apr 2012. 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 Norway. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The ability of mindfulness measured by the Five Facet Mindfulness Questionnaire (time frame: Three months before to one year follow up after the intervention). 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 12 Apr 2012.