StressNCT03403335
Mindfulness Practices for Healthcare Professional Trainees
A study testing Mindfulness Based Practices for Health Care Professionals in Training in people with Stress, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in Training: Clinical Applications, will be piloted to determine the feasibility and accessibility within this population. 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?
- Mindfulness Based Practices for Health Care Professionals in Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2018to 28 Apr 2019
- 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
- Students/faculty from any health care department at VCU
Who cannot join
- Anyone who is not a student/faculty from a health care department at VCU
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in Training: Clinical Applications, will be piloted to determine the feasibility and accessibility within this population. The purpose of the proposed study is to assess the change in perceived stress at work/school and psychological symptomology; i.e., depression, stress, emotion regulation, and dispositional mindfulness, from pre to post intervention in health care professional students and when compared to a matched control group.
Read the detailed description
The proposed study aims to investigate an 8-week intervention: Mindfulness Based Practices for Health Care Professionals in Training: Clinical Applications. During the intervention, participants will engage in didactic education, experiential mindfulness practices, including gentle yoga, and group dialogue. The aim of the study is to investigate the feasibility of this intervention in producing measurable differences between the participants and matched controls on their perception of their well-being and clinical work.
- Conditions
- Stress
- Being tested
- Mindfulness Based Practices for Health Care Professionals in Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Practices for Health Care Professionals in TrainingBehavioural
Eight weekly sessions including didactic lecture, discussion, homework, gentle yoga, and meditation and mindfulness exercises
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Practices for Health Care Professionals | Experimental | Not described Receives: Behavioral: Mindfulness Based Practices for Health Care Professionals in Training |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in burnout
Assessed using Maslach Burnout Inventory a 22 item screening tool with higher values indicating more burnout
Measured: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Change in depressive symptoms
Assessed using Patient Health Questionnaire 9. 9-items with lower values indicating less depression
Measured: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Change in state anxiety
Assessed using State Trait Anxiety Inventory -- a 20 item measure with some items reverse scored and higher scored indicating higher state anxiety
Measured: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Change in ruminative thinking
Assessed using Rumination Response Scale -- a 10 item measure with higher scores indicating higher rumination
Measured: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Change in stress
Assessed using Perceived Stress Scale -- a 14-item scale with higher scores indicating higher levels of stress
Measured: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Change in dispositional mindfulness
Assessed using Five Facet Mindfulness Questionnaire -- a 39-item measure of 5 domains of mindfulness in daily life, with higher scores indicating higher levels of mindfulness
Measured: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Change in cognitive functioning
Assessed using Trail Making Test A \& B -- a brief task requiring respondents to connect numbered dots and then switch between number and letters, speed and accuracy are both recorded
Measured: administered at baseline and post-intervention (8 weeks)
Secondary outcomes (2)
Change in interprofessional attitudes measure
Assessed using Interprofessional Team Training Assessment -- a 22-item measure and Student Perceptions of Physician-Pharmacist Interprofessional Clinical Education -- a 10-item measure; both with higher scores indicating more positive attitudes toward interprofessional training
Measured: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Follow-up Interview of Perceptions of Mindfulness and Interprofessional Education
qualitative interview and exploration -- participants will spend approximately 30 minute by phone being interviewed on their experiences with the intervention especially in the context of healthcare and interprofessional education
Measured: assessed at 3-month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start9 Feb 2018
- Primary completion31 Dec 2018
- Study completion28 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Association (APA)
- Responsible party
- Sponsor
- Investigators
- Bruce Rybarczyk, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403335
- Sponsor's protocol ID
- HM20012397
- Status last verified
- May 2019
- First submitted
- 11 Jan 2018
- Last updated
- 4 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Braun SE, Mladen SN, Luberto CM, Kinser PA. Maintenance of Effects and Correlates of Changes Following Mindfulness for Interdisciplinary Health Care Professional Students. Integr Med Rep. 2022 Sep 1;1(1):177-185. doi: 10.1089/imr.2021.0012. Epub 2022 Sep 7.
PubMed 36212225
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Practices for Healthcare Professional Trainees
- ClinicalTrials.gov ID
- NCT03403335
- Acronym / sponsor ID
- HM20012397
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Psychological Association (APA)
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 28 Apr 2019 (actual)
- First posted
- 18 Jan 2018 (actual)
- 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.
A newly developed intervention, Mindfulness Based Practices for Health Care Professionals in Training: Clinical Applications, will be piloted to determine the feasibility and accessibility within this population. The purpose of the proposed study is to assess the change in perceived stress at work/school and psychological symptomology; i.e., depression, stress, emotion regulation, and dispositional mindfulness, from pre to post intervention in health care professional students and when compared to a matched control group.
Detailed description
The proposed study aims to investigate an 8-week intervention: Mindfulness Based Practices for Health Care Professionals in Training: Clinical Applications. During the intervention, participants will engage in didactic education, experiential mindfulness practices, including gentle yoga, and group dialogue. The aim of the study is to investigate the feasibility of this intervention in producing measurable differences between the participants and matched controls on their perception of their well-being and clinical work.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Practices for Health Care Professionals | Experimental | Behavioral: Mindfulness Based Practices for Health Care Professionals in Training |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Students/faculty from any health care department at VCU
Key exclusion criteria (1 listed)
- Anyone who is not a student/faculty from a health care department at VCU
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 Based Practices for Health Care Professionals in TrainingEight weekly sessions including didactic lecture, discussion, homework, gentle yoga, and meditation and mindfulness exercises | Behavioural | Mindfulness Based Practices for Health Care Professionals |
Primary outcome
Change in burnout
Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Assessed using Maslach Burnout Inventory a 22 item screening tool with higher values indicating more burnout
Change in depressive symptoms
Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Assessed using Patient Health Questionnaire 9. 9-items with lower values indicating less depression
Change in state anxiety
Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Assessed using State Trait Anxiety Inventory -- a 20 item measure with some items reverse scored and higher scored indicating higher state anxiety
Change in ruminative thinking
Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Assessed using Rumination Response Scale -- a 10 item measure with higher scores indicating higher rumination
Change in stress
Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Assessed using Perceived Stress Scale -- a 14-item scale with higher scores indicating higher levels of stress
Change in dispositional mindfulness
Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Assessed using Five Facet Mindfulness Questionnaire -- a 39-item measure of 5 domains of mindfulness in daily life, with higher scores indicating higher levels of mindfulness
Change in cognitive functioning
Time frame: administered at baseline and post-intervention (8 weeks)
Assessed using Trail Making Test A \& B -- a brief task requiring respondents to connect numbered dots and then switch between number and letters, speed and accuracy are both recorded
2 secondary outcomes
Change in interprofessional attitudes measure
Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Follow-up Interview of Perceptions of Mindfulness and Interprofessional Education
Time frame: assessed at 3-month post-intervention follow-up
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 4 Jun 2019.
- Derived from this study: PubMed 36212225Braun SE, Mladen SN, Luberto CM, Kinser PA. Maintenance of Effects and Correlates of Changes Following Mindfulness for Interdisciplinary Health Care Professional Students. Integr Med Rep. 2022 Sep 1;1(1):177-185. doi: 10.1089/imr.2021.0012. Epub 2022 Sep 7.
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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.
Bruce Rybarczyk, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Practices for Health Care Professionals in Training in people with Stress, run by Virginia Commonwealth University 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 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 4 Jun 2019. 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?
Change in burnout (time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03403335, which also lists 1 linked publication.
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 4 Jun 2019; AzTrials last refreshed its copy on 31 Oct 2026.