NCT06003699

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

August 16, 2023

Last Update Submit

June 26, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (5)

  • Change in Attentional Performance

    Baseline, up to 11 weeks

  • Change in Depression and Anxiety

    Baseline, up to 11 weeks

  • Change in Burnout

    Baseline, up to 11 weeks

  • Change in Flourishing

    Baseline, up to 11 weeks

  • Change in Sleep

    Baseline, up to 11 weeks

Study Arms (2)

Mindfulness training group

EXPERIMENTAL

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

Wait-list Control Group

ACTIVE COMPARATOR

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

Interventions

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.

Mindfulness training groupWait-list Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLaren Health Care Corporation

Grand Blanc, Michigan, 48439, United States

Location

MeSH Terms

Conditions

Burnout, ProfessionalEmotional Regulation

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehaviorSelf-ControlSocial Behavior

Study Officials

  • Amishi Jha, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 22, 2023

Study Start

February 1, 2024

Primary Completion

June 10, 2024

Study Completion

June 18, 2024

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations