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CompletedNCT03403335Updated Jun 4, 2019

Mindfulness Practices for Healthcare Professional Trainees

An interventional study of Mindfulness Based Practices for Health Care Professionals in Training in Stress, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-04.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Stress
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Students/faculty from any health care department at VCU

Exclusion criteria

Exclusion Criteria:

  • Anyone who is not a student/faculty from a health care department at VCU
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Mindfulness Based Practices for Health Care Professionals

    Behavioral: Mindfulness Based Practices for Health Care Professionals in Training

  • No intervention
    Control Group

Interventions

  • BehavioralMindfulness Based Practices for Health Care Professionals in Training

    Eight weekly sessions including didactic lecture, discussion, homework, gentle yoga, and meditation and mindfulness exercises

05

What researchers measure

Primary outcomes

  1. Change in burnout

    Assessed using Maslach Burnout Inventory a 22 item screening tool with higher values indicating more burnout

    Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up

  2. Change in depressive symptoms

    Assessed using Patient Health Questionnaire 9. 9-items with lower values indicating less depression

    Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up

  3. 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

    Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up

  4. Change in ruminative thinking

    Assessed using Rumination Response Scale -- a 10 item measure with higher scores indicating higher rumination

    Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up

  5. Change in stress

    Assessed using Perceived Stress Scale -- a 14-item scale with higher scores indicating higher levels of stress

    Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up

  6. 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

    Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up

  7. 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

    Time frame: administered at baseline and post-intervention (8 weeks)

Secondary outcomes

  1. 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

    Time frame: administered at baseline, post-intervention (8 weeks), and 3 month post-intervention follow-up

  2. 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

    Time frame: assessed at 3-month post-intervention follow-up

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Study locations

1 site
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
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References and documents

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 ↗
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Registry details

Key details

Study ID
NCT03403335
Lead sponsor
Virginia Commonwealth University
Collaborators
American Psychological Association (APA)
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Feb 9, 2018
Primary completion
Dec 31, 2018
Completion
Apr 28, 2019
Last update
Jun 4, 2019

Study contacts

Bruce Rybarczyk, PhD
principal investigator · Virginia Commonwealth University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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