NCT04425356

Brief Summary

The objective of this study is to determine whether a mindfulness coaching program was efficacious at reducing work stress, improving psychological and physical health outcomes, and improving work outcomes. The target population is employed adults (18 years and older) working in the industries of media, consulting, and healthcare.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

3 active sites

Status
unknown

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

Study Start

First participant enrolled

April 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.8 years

First QC Date

June 3, 2020

Last Update Submit

June 9, 2020

Conditions

Keywords

Resilience, PsychologicalEnergy LevelEmpathyEmotional IntelligenceSatisfaction with RelationshipsHappinessSleep QualityPhysical HealthPresenteeismFocusCollective EfficacyJob SatisfactionJob Engagement

Outcome Measures

Primary Outcomes (6)

  • Mindfulness

    Mindfulness is assessed using the Mindfulness Attention Awareness Scale (MAAS) consisting of 15 items. Higher scores reflect higher levels of dispositional mindfulness. The scale has been validated in college, working adult, and cancer patient populations (Brown and Ryan, 2003). The scale range was changed from 1-6 to 1-7 when adapted and added into the LIFE XT personal health assessment.

    Assessed at baseline

  • Mindfulness

    Mindfulness is assessed using the Mindfulness Attention Awareness Scale (MAAS) consisting of 15 items. Higher scores reflect higher levels of dispositional mindfulness. The scale has been validated in college, working adult, and cancer patient populations (Brown and Ryan, 2003). The scale range was changed from 1-6 to 1-7 when adapted and added into the LIFE XT personal health assessment.

    Assessed immediately post-intervention (4 moths after baseline)

  • Mindfulness

    Mindfulness is assessed using the Mindfulness Attention Awareness Scale (MAAS) consisting of 15 items. Higher scores reflect higher levels of dispositional mindfulness. The scale has been validated in college, working adult, and cancer patient populations (Brown and Ryan, 2003). The scale range was changed from 1-6 to 1-7 when adapted and added into the LIFE XT personal health assessment.

    Assessed at follow-up (3 months post intervention)

  • Stress

    Stress is assessed using 4 items from the 10-item Perceived Stress Scale (PSS). The PSS has demonstrated internal consistency and validity (Cohen, 1983). The PSS asks respondents to indicate how often they felt or thought a certain way during a specified time period (i.e., over the last 2 weeks). Examples of items include, "how often have you felt that you were unable to control the important things in your life," and "how often have you felt that things were going your way." The sale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment. Higher scores reflect higher levels of perceived stress.

    Assessed at baseline

  • Stress

    Stress is assessed using 4 items from the 10-item Perceived Stress Scale (PSS). The PSS has demonstrated internal consistency and validity (Cohen, 1983). The PSS asks respondents to indicate how often they felt or thought a certain way during a specified time period (i.e., over the last 2 weeks). Examples of items include, "how often have you felt that you were unable to control the important things in your life," and "how often have you felt that things were going your way." The sale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment. Higher scores reflect higher levels of perceived stress.

    Assessed immediately post-intervention (4 moths after baseline)

  • Stress

    Stress is assessed using 4 items from the 10-item Perceived Stress Scale (PSS). The PSS has demonstrated internal consistency and validity (Cohen, 1983). The PSS asks respondents to indicate how often they felt or thought a certain way during a specified time period (i.e., over the last 2 weeks). Examples of items include, "how often have you felt that you were unable to control the important things in your life," and "how often have you felt that things were going your way." The sale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment. Higher scores reflect higher levels of perceived stress.

    Assessed at follow-up (3 months post intervention)

Secondary Outcomes (36)

  • Energy

    Assessed at baseline

  • Energy

    Assessed immediately post-intervention (4 months after baseline)

  • Energy

    Assessed at follow-up (3 months post intervention)

  • Empathy

    Assessed at baseline

  • Empathy

    Assessed immediately post-intervention (4 months after baseline)

  • +31 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group will receive the LifeXT program

Behavioral: LifeXT Program

Control Group

NO INTERVENTION

Wait-list control group that receives the LifeXT program after the conclusion of the study

Interventions

LifeXT ProgramBEHAVIORAL

The intervention involves participation in and completion of the 4-month LIFEXT program, including: A baseline 15-20 minute health assessment administered online, a 50 minute introductory, one-on-one telephonic coaching session, four 50 minute one-on-one telephonic coaching sessions, optional coaching session follow-up activities (such as videos, practice exercises, and reading materials), and a post-intervention 15-20 minute health assessment administered online.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Employees who are eligible to take the company's health risk assessment and/or biometric screening
  • Employees who are eligible for medical health benefits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Navicent Health

Macon, Georgia, 31201, United States

Location

Spark Foundry

Chicago, Illinois, 60601, United States

Location

The Leo Burnett Media Agency

Chicago, Illinois, 60601, United States

Location

MeSH Terms

Conditions

Occupational StressSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Chris Calitz, MPP

    American Heart Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The primary investigator and team (including those involved with the data analysis) have no knowledge of which participants were assigned to intervention or control groups. Group assignment was conducted by Life Cross Training independently of the AHA investigation team. Participants are not blinded to their group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three experimental groups (1 from each of the 3 different implementation sites) will receive the intervention while 3 control groups will not. The control groups will be placed on a waitlist to receive the intervention once the study period is complete.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 11, 2020

Study Start

April 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations