NCT03403335

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

February 9, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2019

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

January 11, 2018

Last Update Submit

May 31, 2019

Conditions

Stress

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Change in interprofessional attitudes measure

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

  • Follow-up Interview of Perceptions of Mindfulness and Interprofessional Education

    assessed at 3-month post-intervention follow-up

Study Arms (2)

Mindfulness Based Practices for Health Care Professionals

EXPERIMENTAL
Behavioral: Mindfulness Based Practices for Health Care Professionals in Training

Control Group

NO INTERVENTION

Interventions

Mindfulness Based Practices for Health Care Professionals in TrainingBEHAVIORAL

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

Mindfulness Based Practices for Health Care Professionals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Students/faculty from any health care department at VCU

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • 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.

    PMID: 36212225DERIVED

MeSH Terms

Interventions

Health Personnel

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

  • Bruce Rybarczyk, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

February 9, 2018

Primary Completion

December 31, 2018

Study Completion

April 28, 2019

Last Updated

June 4, 2019

Record last verified: 2019-05

Locations

US(1)