Mindfulness Training in the Medical Health Care System

Sponsor
University of Miami (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003699
Collaborator
(none)
150
1
2
2.9
51.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Search Inside Yourself (SIY) program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Mindfulness Training in the Medical Health Care System
Anticipated Study Start Date :
Mar 4, 2024
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness training group

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.

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.

Active Comparator: Wait-list Control Group

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Positive Affect [Baseline, up to 11 weeks]

    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.

  2. Change in Negative Affect [Baseline, up to 11 weeks]

    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.

  3. Change in Perceived Stress [Baseline, up to 11 weeks]

    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.

  4. Change in Decentering [Baseline, up to 11 weeks]

    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.

  5. Change in Acting with Awareness [Baseline, up to 11 weeks]

    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.

  6. Change in Leadership Self-Awareness [Baseline, up to 11 weeks]

    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.

  7. Change in Workplace Emotional Intelligence [Baseline, up to 11 weeks]

    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

  1. Change in Attentional Performance [Baseline, up to 11 weeks]

    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.

  2. Change in Depression and Anxiety [Baseline, up to 11 weeks]

    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.

  3. Change in Burnout [Baseline, up to 11 weeks]

    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.

  4. Change in Sleep [Baseline, up to 11 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 McLaren Health Care Corporation Grand Blanc Michigan United States 48439

Sponsors and Collaborators

  • University of Miami

Investigators

  • Principal Investigator: Amishi Jha, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amishi Jha, Professor, University of Miami
ClinicalTrials.gov Identifier:
NCT06003699
Other Study ID Numbers:
  • 20230690
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023