MindfulnessNCT04425356
Are Mindfulness Programs in the Workplace Effective at Reducing Stress
A study testing LifeXT Program in people with Mindfulness and Occupational Stress, run by American Heart Association at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Occupational Stress
- What is being tested?
- LifeXT Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employees who are eligible to take the company's health risk assessment and/or biometric screening
- Employees who are eligible for medical health benefits
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Spark Foundry
Chicago, Illinois, 60601
The Leo Burnett Media Agency
Chicago, Illinois, 60601
Navicent Health
Macon, Georgia, 31201
About this study
Official title: 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.
- Conditions
- Mindfulness, Occupational Stress
- Being tested
- LifeXT Program
- Keywords
- Resilience, Psychological, Energy Level, Empathy, Emotional Intelligence, Satisfaction with Relationships, Happiness, Sleep Quality, Physical Health, Presenteeism, Focus, Collective Efficacy, Job Satisfaction, Job Engagement
- Medical subject headings
- Occupational Stress, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeXT ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group will receive the LifeXT program Receives: Behavioral: LifeXT Program |
| Control Group | No intervention | Wait-list control group that receives the LifeXT program after the conclusion of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at follow-up (3 months post intervention)
Secondary outcomes (36)
Energy
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.
Measured: Assessed at baseline
Energy
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.
Measured: Assessed immediately post-intervention (4 months after baseline)
Energy
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.
Measured: Assessed at follow-up (3 months post intervention)
Empathy
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.
Measured: Assessed at baseline
Empathy
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.
Measured: Assessed immediately post-intervention (4 months after baseline)
Empathy
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.
Measured: Assessed at follow-up (3 months post intervention)
Emotional Health
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.
Measured: Assessed at baseline
Emotional Health
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.
Measured: Assessed immediately post-intervention (4 months after baseline)
Emotional Health
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.
Measured: Assessed at follow-up (3 months post intervention)
Relationships (Satisfaction with): questionnaire
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.
Measured: Assessed at baseline
Relationships (Satisfaction with): questionnaire
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.
Measured: Assessed immediately post-intervention (4 months after baseline)
Relationships (Satisfaction with): questionnaire
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.
Measured: Assessed at follow-up (3 months post intervention)
Happiness (Life Satisfaction): questionnaire
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.
Measured: Assessed at baseline
Happiness (Life Satisfaction): questionnaire
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.
Measured: Assessed immediately post-intervention (4 months after baseline)
Happiness (Life Satisfaction): questionnaire
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.
Measured: Assessed at follow-up (3 months post intervention)
Physical Health
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.
Measured: Assessed at baseline
Physical Health
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.
Measured: Assessed immediately post-intervention (4 months after baseline)
Physical Health
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.
Measured: Assessed at follow-up (3 months post intervention)
Sleep Quality: PSQI
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.
Measured: Assessed at baseline
Sleep Quality: PSQI
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.
Measured: Assessed immediately post-intervention (4 months after baseline)
Sleep Quality: PSQI
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.
Measured: Assessed at follow-up (3 months post intervention)
Productivity (or work impairment)
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
Measured: Assessed at baseline
Productivity (or work impairment)
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
Measured: Assessed immediately post-intervention (4 months after baseline)
Productivity (or work impairment)
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
Measured: Assessed at follow-up (3 months post intervention)
Presenteeism
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.
Measured: Assessed at baseline
Presenteeism
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.
Measured: Assessed immediately post-intervention (4 months after baseline)
Presenteeism
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.
Measured: Assessed at follow-up (3 months post intervention)
Employee Retention
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?"
Measured: Assessed at baseline
Employee Retention
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?"
Measured: Assessed immediately post-intervention (4 months after baseline)
Employee Retention
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?"
Measured: Assessed at follow-up (3 months post intervention)
Teamwork (collective efficacy)
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.
Measured: Assessed at baseline
Teamwork (collective efficacy)
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.
Measured: Assessed immediately post-intervention (4 months after baseline)
Teamwork (collective efficacy)
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.
Measured: Assessed at follow-up (3 months post intervention)
Job Satisfaction: WOS
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.
Measured: Assessed at baseline
Job Satisfaction: WOS
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.
Measured: Assessed immediately post-intervention (4 months after baseline)
Job Satisfaction: WOS
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.
Measured: Assessed at follow-up (3 months post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Apr 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Heart Association
- Sponsor type
- University, hospital or other
- Collaborators
- Life Cross Training
- Responsible party
- Sponsor
- Investigators
- Chris Calitz, MPP, Principal investigator, American Heart Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425356
- Sponsor's protocol ID
- LifeXT2019
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Mindfulness Coaching Program for Stress Management: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04425356
- Acronym / sponsor ID
- LifeXT2019
- Conditions
- Mindfulness, Occupational Stress
- Keywords
- Resilience, Psychological, Energy Level, Empathy, Emotional Intelligence, Satisfaction with Relationships, Happiness, Sleep Quality, Physical Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- American Heart AssociationUniversity, hospital or other
- Collaborators
- Life Cross Training
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: LifeXT ProgramThis group will receive the LifeXT program |
| Control Group | No intervention | –Wait-list control group that receives the LifeXT program after the conclusion of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employees who are eligible to take the company's health risk assessment and/or biometric screening
- Employees who are eligible for medical health benefits
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifeXT ProgramThe 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
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.
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.
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.
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.
36 secondary outcomes
Energy
Time frame: Assessed at baseline
Energy
Time frame: Assessed immediately post-intervention (4 months after baseline)
Energy
Time frame: Assessed at follow-up (3 months post intervention)
Empathy
Time frame: Assessed at baseline
Empathy
Time frame: Assessed immediately post-intervention (4 months after baseline)
Empathy
Time frame: Assessed at follow-up (3 months post intervention)
Emotional Health
Time frame: Assessed at baseline
Emotional Health
Time frame: Assessed immediately post-intervention (4 months after baseline)
Emotional Health
Time frame: Assessed at follow-up (3 months post intervention)
Relationships (Satisfaction with): questionnaire
Time frame: Assessed at baseline
Relationships (Satisfaction with): questionnaire
Time frame: Assessed immediately post-intervention (4 months after baseline)
Relationships (Satisfaction with): questionnaire
Time frame: Assessed at follow-up (3 months post intervention)
Happiness (Life Satisfaction): questionnaire
Time frame: Assessed at baseline
Happiness (Life Satisfaction): questionnaire
Time frame: Assessed immediately post-intervention (4 months after baseline)
Happiness (Life Satisfaction): questionnaire
Time frame: Assessed at follow-up (3 months post intervention)
Physical Health
Time frame: Assessed at baseline
Physical Health
Time frame: Assessed immediately post-intervention (4 months after baseline)
Physical Health
Time frame: Assessed at follow-up (3 months post intervention)
Sleep Quality: PSQI
Time frame: Assessed at baseline
Sleep Quality: PSQI
Time frame: Assessed immediately post-intervention (4 months after baseline)
Sleep Quality: PSQI
Time frame: Assessed at follow-up (3 months post intervention)
Productivity (or work impairment)
Time frame: Assessed at baseline
Productivity (or work impairment)
Time frame: Assessed immediately post-intervention (4 months after baseline)
Productivity (or work impairment)
Time frame: Assessed at follow-up (3 months post intervention)
Presenteeism
Time frame: Assessed at baseline
Presenteeism
Time frame: Assessed immediately post-intervention (4 months after baseline)
Presenteeism
Time frame: Assessed at follow-up (3 months post intervention)
Employee Retention
Time frame: Assessed at baseline
Employee Retention
Time frame: Assessed immediately post-intervention (4 months after baseline)
Employee Retention
Time frame: Assessed at follow-up (3 months post intervention)
Teamwork (collective efficacy)
Time frame: Assessed at baseline
Teamwork (collective efficacy)
Time frame: Assessed immediately post-intervention (4 months after baseline)
Teamwork (collective efficacy)
Time frame: Assessed at follow-up (3 months post intervention)
Job Satisfaction: WOS
Time frame: Assessed at baseline
Job Satisfaction: WOS
Time frame: Assessed immediately post-intervention (4 months after baseline)
Job Satisfaction: WOS
Time frame: Assessed at follow-up (3 months post intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Recruiting
Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurological Disorders
Caregiver
Recruiting
Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer.
Non Metastatic Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Calitz, MPP principal investigator
American Heart Association
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeXT Program in people with Mindfulness and Occupational Stress, run by American Heart Association at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness (time frame: Assessed at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.