Clinical trial NCT04425356: Are Mindfulness Programs in the Workplace Effective at Reducing Stress
Official title: Evaluation of the Effectiveness of a Mindfulness Coaching Program for Stress Management: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mindfulness
Occupational Stress
Keywords: Resilience, Psychological
Energy Level
Empathy
Emotional Intelligence
Satisfaction with Relationships
Happiness
Sleep Quality
Physical Health
Presenteeism
Focus
Collective Efficacy
Job Satisfaction
Job Engagement
Lead sponsor: American Heart Association
Sponsor class: OTHER
Collaborators: name: Life Cross Training
First posted: 2020-06-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Mindfulness
timeFrame: Assessed at baseline
measure: Mindfulness
timeFrame: Assessed immediately post-intervention (4 moths after baseline)
measure: Mindfulness
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Stress
timeFrame: Assessed at baseline
measure: Stress
timeFrame: Assessed immediately post-intervention (4 moths after baseline)
measure: Stress
timeFrame: Assessed at follow-up (3 months post intervention)
Secondary outcomes:
measure: Energy
timeFrame: Assessed at baseline
measure: Energy
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Energy
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Empathy
timeFrame: Assessed at baseline
measure: Empathy
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Empathy
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Emotional Health
timeFrame: Assessed at baseline
measure: Emotional Health
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Emotional Health
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Relationships (Satisfaction with): questionnaire
timeFrame: Assessed at baseline
measure: Relationships (Satisfaction with): questionnaire
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Relationships (Satisfaction with): questionnaire
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Happiness (Life Satisfaction): questionnaire
timeFrame: Assessed at baseline
measure: Happiness (Life Satisfaction): questionnaire
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Happiness (Life Satisfaction): questionnaire
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Physical Health
timeFrame: Assessed at baseline
measure: Physical Health
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Physical Health
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Sleep Quality: PSQI
timeFrame: Assessed at baseline
measure: Sleep Quality: PSQI
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Sleep Quality: PSQI
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Productivity (or work impairment)
timeFrame: Assessed at baseline
measure: Productivity (or work impairment)
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Productivity (or work impairment)
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Presenteeism
timeFrame: Assessed at baseline
measure: Presenteeism
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Presenteeism
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Employee Retention
timeFrame: Assessed at baseline
measure: Employee Retention
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Employee Retention
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Teamwork (collective efficacy)
timeFrame: Assessed at baseline
measure: Teamwork (collective efficacy)
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Teamwork (collective efficacy)
timeFrame: Assessed at follow-up (3 months post intervention)
measure: Job Satisfaction: WOS
timeFrame: Assessed at baseline
measure: Job Satisfaction: WOS
timeFrame: Assessed immediately post-intervention (4 months after baseline)
measure: Job Satisfaction: WOS
timeFrame: Assessed at follow-up (3 months post intervention)
Other outcomes:
Locations:
city: Macon
country: United States
facility: Navicent Health
state: Georgia
city: Chicago
country: United States
facility: Spark Foundry
state: Illinois
city: Chicago
country: United States
facility: The Leo Burnett Media Agency
state: Illinois
Study officials:
affiliation: American Heart Association
name: Chris Calitz, MPP
role: PRINCIPAL_INVESTIGATOR
References: