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Mindfulness Training in the Medical Health Care System

Primary Purpose

Burnout, Professional, Stress, Emotion Regulation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Search Inside Yourself (SIY) program
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burnout, Professional

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals who are between 18 and 80 years of age Individuals who are fluent English speakers Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection Individuals who are willing and able to consent to participate in the study Exclusion Criteria: 1. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month

Sites / Locations

  • McLaren Health Care Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness training group

Wait-list Control Group

Arm Description

Participants will receive 4 weeks of mindfulness-based training and then continue to have access to the mindfulness training exercise throughout the second training interval.

Participants will not receive 4 weeks of mindfulness-based training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval.

Outcomes

Primary Outcome Measures

Change in Positive Affect
Positive Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Positive has a range of scores from 5 to 25, with a higher score indicating a higher positive mood.
Change in Negative Affect
Negative Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Negative has a range of scores from 5 to 25, with a higher score indicating a higher negative mood.
Change in Perceived Stress
Perceived stress is assessed with the 4-item Perceived Stress Scale (PSS-4). PSS-4 has a range of scores from 0 to 16, with a higher score indicating a higher level of perceived stress.
Change in Decentering
Decentering is assessed via the 11-item decentering sub-scale of the experience questionnaire (EQ-D). The decentering score ranges from 1 to 55, with a higher score indicating a higher level of decentering.
Change in Acting with Awareness
Mindfulness attitude related to awareness is assessed with the 3-item acting with awareness sub-scale from the Five Factor Mindfulness Questionnaire (FFMQ). Each item is rated on a 5-point scale and higher scores indicate greater awareness.
Change in Leadership Self-Awareness
Leadership Self-Awareness is assessed with the 4-item self-awareness sub-scale from the Authentic Leadership Questionnaire (ALQ). Each item is rated on a 5-point Likert Scale ranging from 0 ("not at all") to 4 ("frequently"), and higher scores indicate greater self-awareness.
Change in Workplace Emotional Intelligence
Workplace Emotional Intelligence is assessed with the 16-item Workplace Emotional Intelligence Profile Scale (WEIPS). Each item is rated on a scale from 1("strongly disagree") to 7 ("strongly"), and higher scores indicate greater emotional intelligence.

Secondary Outcome Measures

Change in Attentional Performance
The Sustained Attention Response Task (SART) is used to assess attentional performance and mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand). SART has a range of scores from 0 to 1 with a higher score indicating better accuracy when completing the task.
Change in Depression and Anxiety
Depression and anxiety is assessed with the 4-item Patient Health Questionnaire (PHQ-4) Each item is rated from 0 ("not at all") to 3 ("nearly every day"), and ratings are summed together. PHQ-4 has a range of scores from 0 to 12, with higher scores indicating higher levels of depression and anxiety.
Change in Burnout
Burnout will be assessed with the 12-item Burnout Assessment Tool (BAT-12). Each item is rated on a 5-point Likert scale from 0 ("never") to 5 ("always"). Ratings are then averaged on a scale of 0 to 5, where a higher score indicates greater burnout.
Change in Sleep
Sleep problems will be assessed with the 4-items of the Insomnia Sensitivity Index (ISI-4). Each item is rated on a 5-point Likert scale and ratings are summed together. ISI-4 has a range of scores from 5 to 20, with higher score indicating more severe sleep problems.

Full Information

First Posted
August 16, 2023
Last Updated
August 16, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT06003699
Brief Title
Mindfulness Training in the Medical Health Care System
Official Title
Mindfulness Training in the Medical Health Care System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 4, 2024 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to look at how mindfulness-informed emotional intelligence training may influence how participants think, feel, and act.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional, Stress, Emotion Regulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness training group
Arm Type
Experimental
Arm Description
Participants will receive 4 weeks of mindfulness-based training and then continue to have access to the mindfulness training exercise throughout the second training interval.
Arm Title
Wait-list Control Group
Arm Type
Active Comparator
Arm Description
Participants will not receive 4 weeks of mindfulness-based training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval.
Intervention Type
Behavioral
Intervention Name(s)
Search Inside Yourself (SIY) program
Intervention Description
The present project involves the delivery of the Search Inside Yourself (SIY) program. The SIY Program is organized into 6 thematic modules. The first module introduces mindfulness and emotional intelligence and provides scientific evidence for the benefits of practicing mindfulness. The second module introduces Self-Awareness. The remaining four modules cover other domains based on Daniel Goleman's original framework of Emotional Intelligence: self-management, motivation, empathy, and leadership. Each module is associated with a set of practices, such as focused attention, body scan, journaling, empathic listening, and a Leadership Commitment exercise. The program will be delivered over 4 weeks, with one 3-hour session per week for a total of 12 hours that will take to complete all the modules.
Primary Outcome Measure Information:
Title
Change in Positive Affect
Description
Positive Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Positive has a range of scores from 5 to 25, with a higher score indicating a higher positive mood.
Time Frame
Baseline, up to 11 weeks
Title
Change in Negative Affect
Description
Negative Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Negative has a range of scores from 5 to 25, with a higher score indicating a higher negative mood.
Time Frame
Baseline, up to 11 weeks
Title
Change in Perceived Stress
Description
Perceived stress is assessed with the 4-item Perceived Stress Scale (PSS-4). PSS-4 has a range of scores from 0 to 16, with a higher score indicating a higher level of perceived stress.
Time Frame
Baseline, up to 11 weeks
Title
Change in Decentering
Description
Decentering is assessed via the 11-item decentering sub-scale of the experience questionnaire (EQ-D). The decentering score ranges from 1 to 55, with a higher score indicating a higher level of decentering.
Time Frame
Baseline, up to 11 weeks
Title
Change in Acting with Awareness
Description
Mindfulness attitude related to awareness is assessed with the 3-item acting with awareness sub-scale from the Five Factor Mindfulness Questionnaire (FFMQ). Each item is rated on a 5-point scale and higher scores indicate greater awareness.
Time Frame
Baseline, up to 11 weeks
Title
Change in Leadership Self-Awareness
Description
Leadership Self-Awareness is assessed with the 4-item self-awareness sub-scale from the Authentic Leadership Questionnaire (ALQ). Each item is rated on a 5-point Likert Scale ranging from 0 ("not at all") to 4 ("frequently"), and higher scores indicate greater self-awareness.
Time Frame
Baseline, up to 11 weeks
Title
Change in Workplace Emotional Intelligence
Description
Workplace Emotional Intelligence is assessed with the 16-item Workplace Emotional Intelligence Profile Scale (WEIPS). Each item is rated on a scale from 1("strongly disagree") to 7 ("strongly"), and higher scores indicate greater emotional intelligence.
Time Frame
Baseline, up to 11 weeks
Secondary Outcome Measure Information:
Title
Change in Attentional Performance
Description
The Sustained Attention Response Task (SART) is used to assess attentional performance and mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand). SART has a range of scores from 0 to 1 with a higher score indicating better accuracy when completing the task.
Time Frame
Baseline, up to 11 weeks
Title
Change in Depression and Anxiety
Description
Depression and anxiety is assessed with the 4-item Patient Health Questionnaire (PHQ-4) Each item is rated from 0 ("not at all") to 3 ("nearly every day"), and ratings are summed together. PHQ-4 has a range of scores from 0 to 12, with higher scores indicating higher levels of depression and anxiety.
Time Frame
Baseline, up to 11 weeks
Title
Change in Burnout
Description
Burnout will be assessed with the 12-item Burnout Assessment Tool (BAT-12). Each item is rated on a 5-point Likert scale from 0 ("never") to 5 ("always"). Ratings are then averaged on a scale of 0 to 5, where a higher score indicates greater burnout.
Time Frame
Baseline, up to 11 weeks
Title
Change in Sleep
Description
Sleep problems will be assessed with the 4-items of the Insomnia Sensitivity Index (ISI-4). Each item is rated on a 5-point Likert scale and ratings are summed together. ISI-4 has a range of scores from 5 to 20, with higher score indicating more severe sleep problems.
Time Frame
Baseline, up to 11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals who are between 18 and 80 years of age Individuals who are fluent English speakers Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection Individuals who are willing and able to consent to participate in the study Exclusion Criteria: 1. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ekaterina Denkova, PhD
Phone
305-284-8148
Email
exn67@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amishi Jha, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLaren Health Care Corporation
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chandan Gupte
Phone
810-342-1148
First Name & Middle Initial & Last Name & Degree
Amishi Jha, PhD
First Name & Middle Initial & Last Name & Degree
Ekaterina Denkova, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Mindfulness Training in the Medical Health Care System

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