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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03403335
Other study ID # HM20012397
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 9, 2018
Est. completion date April 28, 2019

Study information

Verified date May 2019
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date April 28, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness Based Practices for Health Care Professionals in Training
Eight weekly sessions including didactic lecture, discussion, homework, gentle yoga, and meditation and mindfulness exercises

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University American Psychological Association (APA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in burnout 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
Primary Change in depressive symptoms 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
Primary 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 administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Primary Change in ruminative thinking 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
Primary Change in stress 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
Primary 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 administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Primary 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 administered at baseline and post-intervention (8 weeks)
Secondary 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 administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up
Secondary 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 assessed at 3-month post-intervention follow-up
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