Are Mindfulness Programs in the Workplace Effective at Reducing Stress

June 9, 2020 updated by: American Heart Association

Evaluation of the Effectiveness of a Mindfulness Coaching Program for Stress Management: A Randomized Control Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Macon, Georgia, United States, 31201
        • Navicent Health
    • Illinois
      • Chicago, Illinois, United States, 60601
        • Spark Foundry
      • Chicago, Illinois, United States, 60601
        • The Leo Burnett Media Agency

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
This group will receive the LifeXT program
Behavioral: LifeXT Program
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.
No Intervention: Control Group
Wait-list control group that receives the LifeXT program after the conclusion of the study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mindfulness
Time Frame: Assessed at baseline
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
Time Frame: Assessed immediately post-intervention (4 moths after baseline)
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
Time Frame: Assessed at follow-up (3 months post intervention)
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
Time Frame: Assessed at baseline
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
Time Frame: Assessed immediately post-intervention (4 moths after baseline)
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
Time Frame: Assessed at follow-up (3 months post intervention)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Energy
Time Frame: Assessed at baseline
Energy (or vitality) is assessed using the Short-Form-36 (SP-36) which consists of 36 items to assess vitality. Higher scores reflect higher levels of vitality. The SP-36 inspired the question, "During the past month, how often did you experience the following?" in the LIFE XT assessment. The questionnaire asks this question about four items: felt full of pep, felt tired, had a lot energy and felt worn out. Each of these questions is on a scale from 1-7, for a total of 28 points and a higher score reflecting higher energy levels.
Assessed at baseline
Energy
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Energy (or vitality) is assessed using the Short-Form-36 (SP-36) which consists of 36 items to assess vitality. Higher scores reflect higher levels of vitality. The SP-36 inspired the question, "During the past month, how often did you experience the following?" in the LIFE XT assessment. The questionnaire asks this question about four items: felt full of pep, felt tired, had a lot energy and felt worn out. Each of these questions is on a scale from 1-7, for a total of 28 points and a higher score reflecting higher energy levels.
Assessed immediately post-intervention (4 months after baseline)
Energy
Time Frame: Assessed at follow-up (3 months post intervention)
Energy (or vitality) is assessed using the Short-Form-36 (SP-36) which consists of 36 items to assess vitality. Higher scores reflect higher levels of vitality. The SP-36 inspired the question, "During the past month, how often did you experience the following?" in the LIFE XT assessment. The questionnaire asks this question about four items: felt full of pep, felt tired, had a lot energy and felt worn out. Each of these questions is on a scale from 1-7, for a total of 28 points and a higher score reflecting higher energy levels.
Assessed at follow-up (3 months post intervention)
Empathy
Time Frame: Assessed at baseline
Empathy is assessed using the Empathic Concern subscale of the Interpersonal Reactivity Index developed by Davis (1980). The subscale includes 4 items. Examples of items include, "I often have tender, concerned feelings for people less fortunate than I am" and "Other people's misfortunes do not usually disturb me a great deal." The scale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment.
Assessed at baseline
Empathy
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Empathy is assessed using the Empathic Concern subscale of the Interpersonal Reactivity Index developed by Davis (1980). The subscale includes 4 items. Examples of items include, "I often have tender, concerned feelings for people less fortunate than I am" and "Other people's misfortunes do not usually disturb me a great deal." The scale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment.
Assessed immediately post-intervention (4 months after baseline)
Empathy
Time Frame: Assessed at follow-up (3 months post intervention)
Empathy is assessed using the Empathic Concern subscale of the Interpersonal Reactivity Index developed by Davis (1980). The subscale includes 4 items. Examples of items include, "I often have tender, concerned feelings for people less fortunate than I am" and "Other people's misfortunes do not usually disturb me a great deal." The scale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment.
Assessed at follow-up (3 months post intervention)
Emotional Health
Time Frame: Assessed at baseline
Emotional health is assessed using 1 question, "How would you rate your emotional health overall during the past month?" The question was developed by the LIFE XT personal health assessment author.
Assessed at baseline
Emotional Health
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Emotional health is assessed using 1 question, "How would you rate your emotional health overall during the past month?" The question was developed by the LIFE XT personal health assessment author.
Assessed immediately post-intervention (4 months after baseline)
Emotional Health
Time Frame: Assessed at follow-up (3 months post intervention)
Emotional health is assessed using 1 question, "How would you rate your emotional health overall during the past month?" The question was developed by the LIFE XT personal health assessment author.
Assessed at follow-up (3 months post intervention)
Relationships (Satisfaction with): questionnaire
Time Frame: Assessed at baseline
Satisfaction in relationships with children, parents, friends, and relatives is assessed with 4 items, one for each relationship domain. For each of the four relationship domains, the question asks, "On average, how satisfied are you in your relationship with your [parents/friends/relatives]". The scale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment.
Assessed at baseline
Relationships (Satisfaction with): questionnaire
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Satisfaction in relationships with children, parents, friends, and relatives is assessed with 4 items, one for each relationship domain. For each of the four relationship domains, the question asks, "On average, how satisfied are you in your relationship with your [parents/friends/relatives]". The scale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment.
Assessed immediately post-intervention (4 months after baseline)
Relationships (Satisfaction with): questionnaire
Time Frame: Assessed at follow-up (3 months post intervention)
Satisfaction in relationships with children, parents, friends, and relatives is assessed with 4 items, one for each relationship domain. For each of the four relationship domains, the question asks, "On average, how satisfied are you in your relationship with your [parents/friends/relatives]". The scale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment.
Assessed at follow-up (3 months post intervention)
Happiness (Life Satisfaction): questionnaire
Time Frame: Assessed at baseline
Happiness is assessed using 5 items from the Satisfaction with Life Scale (SWLS) developed by Diener et al. The scale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment.
Assessed at baseline
Happiness (Life Satisfaction): questionnaire
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Happiness is assessed using 5 items from the Satisfaction with Life Scale (SWLS) developed by Diener et al. The scale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment.
Assessed immediately post-intervention (4 months after baseline)
Happiness (Life Satisfaction): questionnaire
Time Frame: Assessed at follow-up (3 months post intervention)
Happiness is assessed using 5 items from the Satisfaction with Life Scale (SWLS) developed by Diener et al. The scale range was changed from 1-5 to 1-7 when adapted and added into the LIFE XT personal health assessment.
Assessed at follow-up (3 months post intervention)
Physical Health
Time Frame: Assessed at baseline
Physical Health is assessed using 2 questions. The first item is based on a question developed by researchers Lorig et al., "In general, would you say your health is:… (Circle one) (Excellent = 1, Very Good = 2, Good = 3, Fair = 4, Poor = 5.)" The second question, "How would you rate your physical health overall during the past month?" was developed by the LIFE XT personal health assessment author.
Assessed at baseline
Physical Health
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Physical Health is assessed using 2 questions. The first item is based on a question developed by researchers Lorig et al., "In general, would you say your health is:… (Circle one) (Excellent = 1, Very Good = 2, Good = 3, Fair = 4, Poor = 5.)" The second question, "How would you rate your physical health overall during the past month?" was developed by the LIFE XT personal health assessment author.
Assessed immediately post-intervention (4 months after baseline)
Physical Health
Time Frame: Assessed at follow-up (3 months post intervention)
Physical Health is assessed using 2 questions. The first item is based on a question developed by researchers Lorig et al., "In general, would you say your health is:… (Circle one) (Excellent = 1, Very Good = 2, Good = 3, Fair = 4, Poor = 5.)" The second question, "How would you rate your physical health overall during the past month?" was developed by the LIFE XT personal health assessment author.
Assessed at follow-up (3 months post intervention)
Sleep Quality: PSQI
Time Frame: Assessed at baseline
Sleep is assessed using 1 item from the Pittsburgh Sleep Quality Index (PSQI). The item, "During the past work week, how would you rate your sleep quality overall?" assesses sleep quality. The scale range was change from very good, fairly good, fairly bad, and very bad to 1-7, where 1 is labeled poor, and 7 is labeled excellent.
Assessed at baseline
Sleep Quality: PSQI
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Sleep is assessed using 1 item from the Pittsburgh Sleep Quality Index (PSQI). The item, "During the past work week, how would you rate your sleep quality overall?" assesses sleep quality. The scale range was change from very good, fairly good, fairly bad, and very bad to 1-7, where 1 is labeled poor, and 7 is labeled excellent.
Assessed immediately post-intervention (4 months after baseline)
Sleep Quality: PSQI
Time Frame: Assessed at follow-up (3 months post intervention)
Sleep is assessed using 1 item from the Pittsburgh Sleep Quality Index (PSQI). The item, "During the past work week, how would you rate your sleep quality overall?" assesses sleep quality. The scale range was change from very good, fairly good, fairly bad, and very bad to 1-7, where 1 is labeled poor, and 7 is labeled excellent.
Assessed at follow-up (3 months post intervention)
Productivity (or work impairment)
Time Frame: Assessed at baseline
Work impairment is assessed using the Lam Employment Absence and Productivity Scale (LEAPS) which consists of 7 items that describe how patients are functioning at work. Higher scores indicate higher levels of work impairment. A low score reflects minimal to no work impairment. This tool has been used to help physicians make management decisions such as whether or not a patient should stay at work, whether work functioning improves along with symptoms, and whether changes in treatment are needed to optimize work functioning. It has been validated in patients with major depressive disorder (Lam et al.). The scale range was changed from 0-4
Assessed at baseline
Productivity (or work impairment)
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Work impairment is assessed using the Lam Employment Absence and Productivity Scale (LEAPS) which consists of 7 items that describe how patients are functioning at work. Higher scores indicate higher levels of work impairment. A low score reflects minimal to no work impairment. This tool has been used to help physicians make management decisions such as whether or not a patient should stay at work, whether work functioning improves along with symptoms, and whether changes in treatment are needed to optimize work functioning. It has been validated in patients with major depressive disorder (Lam et al.). The scale range was changed from 0-4
Assessed immediately post-intervention (4 months after baseline)
Productivity (or work impairment)
Time Frame: Assessed at follow-up (3 months post intervention)
Work impairment is assessed using the Lam Employment Absence and Productivity Scale (LEAPS) which consists of 7 items that describe how patients are functioning at work. Higher scores indicate higher levels of work impairment. A low score reflects minimal to no work impairment. This tool has been used to help physicians make management decisions such as whether or not a patient should stay at work, whether work functioning improves along with symptoms, and whether changes in treatment are needed to optimize work functioning. It has been validated in patients with major depressive disorder (Lam et al.). The scale range was changed from 0-4
Assessed at follow-up (3 months post intervention)
Presenteeism
Time Frame: Assessed at baseline
Presenteeism is measured using 5 items from the Workplace Outcome Suite (WOS) instrument developed by Chestnut Global Partners, a provider of employee assistance programs. The items reflect what an employee may do or feel at work.
Assessed at baseline
Presenteeism
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Presenteeism is measured using 5 items from the Workplace Outcome Suite (WOS) instrument developed by Chestnut Global Partners, a provider of employee assistance programs. The items reflect what an employee may do or feel at work.
Assessed immediately post-intervention (4 months after baseline)
Presenteeism
Time Frame: Assessed at follow-up (3 months post intervention)
Presenteeism is measured using 5 items from the Workplace Outcome Suite (WOS) instrument developed by Chestnut Global Partners, a provider of employee assistance programs. The items reflect what an employee may do or feel at work.
Assessed at follow-up (3 months post intervention)
Employee Retention
Time Frame: Assessed at baseline
Employee Retention is measured using 1 item from the Workplace Outcome Suite (WOS) instrument developed by Chestnut Global Partners, a provider of employee assistance programs. The question is, "How likely are you, currently, to consider leaving your job due to work related stress?"
Assessed at baseline
Employee Retention
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Employee Retention is measured using 1 item from the Workplace Outcome Suite (WOS) instrument developed by Chestnut Global Partners, a provider of employee assistance programs. The question is, "How likely are you, currently, to consider leaving your job due to work related stress?"
Assessed immediately post-intervention (4 months after baseline)
Employee Retention
Time Frame: Assessed at follow-up (3 months post intervention)
Employee Retention is measured using 1 item from the Workplace Outcome Suite (WOS) instrument developed by Chestnut Global Partners, a provider of employee assistance programs. The question is, "How likely are you, currently, to consider leaving your job due to work related stress?"
Assessed at follow-up (3 months post intervention)
Teamwork (collective efficacy)
Time Frame: Assessed at baseline
Collective efficacy, or people's shared beliefs in their collective capacity to achieve desired outcomes, is assessed using 5 items adapted from the family efficacy scale for soldiers (Bandura, 2006). These items were adapted in the LIFE XT personal health assessment for employees to reflect their confidence in their work teams.
Assessed at baseline
Teamwork (collective efficacy)
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Collective efficacy, or people's shared beliefs in their collective capacity to achieve desired outcomes, is assessed using 5 items adapted from the family efficacy scale for soldiers (Bandura, 2006). These items were adapted in the LIFE XT personal health assessment for employees to reflect their confidence in their work teams.
Assessed immediately post-intervention (4 months after baseline)
Teamwork (collective efficacy)
Time Frame: Assessed at follow-up (3 months post intervention)
Collective efficacy, or people's shared beliefs in their collective capacity to achieve desired outcomes, is assessed using 5 items adapted from the family efficacy scale for soldiers (Bandura, 2006). These items were adapted in the LIFE XT personal health assessment for employees to reflect their confidence in their work teams.
Assessed at follow-up (3 months post intervention)
Job Satisfaction: WOS
Time Frame: Assessed at baseline
Job satisfaction is measured using 5 items from the Workplace Outcome Suite (WOS) instrument developed by Chestnut Global Partners, a provider of employee assistance programs. The items describe how an individual feels about their work. The items use a scale from strongly disagree to strongly agree.
Assessed at baseline
Job Satisfaction: WOS
Time Frame: Assessed immediately post-intervention (4 months after baseline)
Job satisfaction is measured using 5 items from the Workplace Outcome Suite (WOS) instrument developed by Chestnut Global Partners, a provider of employee assistance programs. The items describe how an individual feels about their work. The items use a scale from strongly disagree to strongly agree.
Assessed immediately post-intervention (4 months after baseline)
Job Satisfaction: WOS
Time Frame: Assessed at follow-up (3 months post intervention)
Job satisfaction is measured using 5 items from the Workplace Outcome Suite (WOS) instrument developed by Chestnut Global Partners, a provider of employee assistance programs. The items describe how an individual feels about their work. The items use a scale from strongly disagree to strongly agree.
Assessed at follow-up (3 months post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American Heart Association

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Life Cross Training

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chris Calitz, MPP, American Heart Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LifeXT2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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