Are Mindfulness Programs in the Workplace Effective at Reducing Stress

Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04425356
• Other study ID #: LifeXT2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2020
• Source: American Heart Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The target population is employed adults (18 years and older) working in the industries of media, consulting, and healthcare.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Mindfulness
• Occupational Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Spark Foundry	Chicago	Illinois
United States	The Leo Burnett Media Agency	Chicago	Illinois
United States	Navicent Health	Macon	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
American Heart Association	Life Cross Training

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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
Primary	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)
Primary	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	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.	Assessed at baseline
Secondary	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.	Assessed immediately post-intervention (4 months after baseline)
Secondary	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.	Assessed at follow-up (3 months post intervention)
Secondary	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.	Assessed at baseline
Secondary	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.	Assessed immediately post-intervention (4 months after baseline)
Secondary	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.	Assessed at follow-up (3 months post intervention)
Secondary	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.	Assessed at baseline
Secondary	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.	Assessed immediately post-intervention (4 months after baseline)
Secondary	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.	Assessed at follow-up (3 months post intervention)
Secondary	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.	Assessed at baseline
Secondary	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.	Assessed immediately post-intervention (4 months after baseline)
Secondary	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.	Assessed at follow-up (3 months post intervention)
Secondary	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.	Assessed at baseline
Secondary	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.	Assessed immediately post-intervention (4 months after baseline)
Secondary	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.	Assessed at follow-up (3 months post intervention)
Secondary	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.	Assessed at baseline
Secondary	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.	Assessed immediately post-intervention (4 months after baseline)
Secondary	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.	Assessed at follow-up (3 months post intervention)
Secondary	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.	Assessed at baseline
Secondary	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.	Assessed immediately post-intervention (4 months after baseline)
Secondary	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.	Assessed at follow-up (3 months post intervention)
Secondary	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	Assessed at baseline
Secondary	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	Assessed immediately post-intervention (4 months after baseline)
Secondary	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	Assessed at follow-up (3 months post intervention)
Secondary	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.	Assessed at baseline
Secondary	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.	Assessed immediately post-intervention (4 months after baseline)
Secondary	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.	Assessed at follow-up (3 months post intervention)
Secondary	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?"	Assessed at baseline
Secondary	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?"	Assessed immediately post-intervention (4 months after baseline)
Secondary	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?"	Assessed at follow-up (3 months post intervention)
Secondary	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.	Assessed at baseline
Secondary	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.	Assessed immediately post-intervention (4 months after baseline)
Secondary	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.	Assessed at follow-up (3 months post intervention)
Secondary	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.	Assessed at baseline
Secondary	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.	Assessed immediately post-intervention (4 months after baseline)
Secondary	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.	Assessed at follow-up (3 months post intervention)