Mindfulness Training in the Medical Health Care System

Stress Clinical Trial

Official title:

Mindfulness Training in the Medical Health Care System

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06003699
• Other study ID #: 20230690
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Individuals who are between 18 and 80 years of age

2. Individuals who are fluent English speakers

3. Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection

4. 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

Related Conditions & MeSH terms

• Burnout, Professional
• Emotion Regulation
• Stress

Intervention

Behavioral:
• Search Inside Yourself (SIY) program
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.

Locations

Country	Name	City	State
United States	McLaren Health Care Corporation	Grand Blanc	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, up to 11 weeks
Primary	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.	Baseline, up to 11 weeks
Primary	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.	Baseline, up to 11 weeks
Primary	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.	Baseline, up to 11 weeks
Primary	Change in Mindfulness	Mindfulness is assessed with the 15-item short version of the Five Factor Mindfulness Questionnaire (FFMQ). The scores range from 15 to 75 with higher scores indicating greater levels of mindfulness.	Baseline, up to 11 weeks
Primary	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.	Baseline, up to 11 weeks
Primary	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.	Baseline, up to 11 weeks
Secondary	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.	Baseline, up to 11 weeks
Secondary	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.	Baseline, up to 11 weeks
Secondary	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.	Baseline, up to 11 weeks
Secondary	Change in Flourishing	Flourishing will be assessed using the 8-item Flourishing Scale. Each item is rated on a 7-point Likert scale from 0 ("Strongly disagree") to 7 ("Strongly agree"). Ratings are then averaged with higher scores representing greater psychological resources and strengths.	Baseline, up to 11 weeks
Secondary	Change in Sleep	Sleep problems will be assessed with one question assessing the overall quality of the participants' sleep. The item is rated on a 4-point Likert scale. Scores range from 0 to 3 with a higher score indicating lower quality sleep.	Baseline, up to 11 weeks