StressNCT02194478
Stress Reduction for Busy Professionals
A study testing Meditation in people with Stress, run by Allina Health System at 1 site in United States.
Trial summary
This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week mind-body/meditation intervention on self-reported quality of life in individuals employed by Allina Health. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2014
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 65 years
- Actively-working healthcare professional employed by Allina Health.
Who cannot join
- Previous participation in an Allina Health stress reduction program
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of a Brief Mind/Body Meditation Intervention for Allina Health Employees
This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week mind-body/meditation intervention on self-reported quality of life in individuals employed by Allina Health. Outcomes will include validated questionnaires for depressive symptomology, perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes of salivary cortisol for a sub-sample of employees.
- Conditions
- Stress
- Being tested
- Meditation
- Keywords
- Stress, Meditation, Mind body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
30 minute, 8 week meditation
| Study group | Role | What they receive |
|---|---|---|
| 8 Week Meditation | Other | Allina Health employees undergoing 8 week meditation intervention Receives: Behavioral: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress change from baseline at week 8
Perceived stress will be measured through the Perceived Stress Scale at baseline and week 8.
Measured: Baseline, Week 8
Secondary outcomes (4)
Salivary Cortisol Levels Change from baseline at week 8
Salivary samples will be obtained at baseline and week 8.
Measured: Baseline, Week 8
Lifestyle Profile change from baseline at week 8
The Lifestyle Profile questionnaire measures self actualization, health responsibility, exercise, nutrition, interpersonal support, and stress management. It will be administered at baseline and week 8.
Measured: Baseline, Week 8
Work productivity and activity impairment change from baseline at week 8
Work productivity and activity impairment will be measured through the WPAI:GH and will be administered at baseline and week 8.
Measured: Baseline, Week 8
Promis-29 score change from baseline at week 8
The Promis-29 is a 29 item questionnaire measuring physical function, fatigue, pain, depression, anxiety, and social role participation. The questionnaire will be administered at baseline and week 8.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffery Dusek, PhD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194478
- Sponsor's protocol ID
- S091301
- Status last verified
- Aug 2016
- First submitted
- 16 Jul 2014
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Brief Mind/Body Meditation Intervention for Allina Health Employees
- ClinicalTrials.gov ID
- NCT02194478
- Acronym / sponsor ID
- S091301
- Conditions
- Stress
- Keywords
- Stress, Meditation, Mind body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Jul 2014 (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.
This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week mind-body/meditation intervention on self-reported quality of life in individuals employed by Allina Health. Outcomes will include validated questionnaires for depressive symptomology, perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes of salivary cortisol for a sub-sample of employees.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 8 Week Meditation | Other | Behavioral: MeditationAllina Health employees undergoing 8 week meditation intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged 18 to 65 years
- Actively-working healthcare professional employed by Allina Health.
Key exclusion criteria (2 listed)
- Previous participation in an Allina Health stress reduction program
- Non-English speaking
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 |
|---|---|---|
| Meditation30 minute, 8 week meditation | Behavioural | 8 Week Meditation |
Primary outcome
Perceived stress change from baseline at week 8
Time frame: Baseline, Week 8
Perceived stress will be measured through the Perceived Stress Scale at baseline and week 8.
4 secondary outcomes
Salivary Cortisol Levels Change from baseline at week 8
Time frame: Baseline, Week 8
Lifestyle Profile change from baseline at week 8
Time frame: Baseline, Week 8
Work productivity and activity impairment change from baseline at week 8
Time frame: Baseline, Week 8
Promis-29 score change from baseline at week 8
Time frame: Baseline, Week 8
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 1 Sep 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.
Jeffery Dusek, PhD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Stress, run by Allina Health System 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 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 1 Sep 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?
Perceived stress change from baseline at week 8 (time frame: Baseline, Week 8). 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 1 Sep 2016.