- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03403335
Mindfulness Practices for Healthcare Professional Trainees
May 31, 2019 updated by: Virginia Commonwealth University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students/faculty from any health care department at VCU
Exclusion Criteria:
- Anyone who is not a student/faculty from a health care department at VCU
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control Group
|
|
EXPERIMENTAL: Mindfulness Based Practices for Health Care Professionals
|
Eight weekly sessions including didactic lecture, discussion, homework, gentle yoga, and meditation and mindfulness exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
|
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
|
administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
|
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
|
administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
|
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
|
administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
|
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
|
administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
|
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
|
administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
|
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
|
administered at baseline and post-intervention (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in interprofessional attitudes measure
Time Frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
|
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
|
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
|
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
|
assessed at 3-month post-intervention follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruce Rybarczyk, PhD, Virginia Commonwealth University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 9, 2018
Primary Completion (ACTUAL)
December 31, 2018
Study Completion (ACTUAL)
April 28, 2019
Study Registration Dates
First Submitted
January 11, 2018
First Submitted That Met QC Criteria
January 11, 2018
First Posted (ACTUAL)
January 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 4, 2019
Last Update Submitted That Met QC Criteria
May 31, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- HM20012397
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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