NCT03803865

Brief Summary

Burnout and stress at work can make individuals less productive, which can carry over into their personal and at-home lives and negatively impact health. Customer service representatives are under especially high strain as they are exposed to significant interpersonal conflict at work, both with frustrated customers and with pressure from coworkers and supervisors. However, recent research has found that different stress management interventions (e.g., mindfulness meditation training) can increase job satisfaction and work productivity. However, individuals with significant stress might find these training program classes difficult to attend with their busy schedules. Newer interventions have focused on smartphone mobile applications as an effective delivery system for these training programs. Thus, the purpose of this project is to conduct a randomized controlled trial (RCT) comparing two different stress management smartphone app programs to evaluate effects on job-related outcomes, functional and structural brain outcomes, and biology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

November 13, 2018

Last Update Submit

July 13, 2020

Conditions

Keywords

Job StressMindfulnessInflammationNeuroimaging

Outcome Measures

Primary Outcomes (18)

  • Burnout

    Evaluated using a burnout scale for customer service representatives. This scale is used to measures feelings of burnout, a psychological disposition characterized by emotional exhaustion, lack of personal accomplishment, and a tendency to depersonalize others. The 24-item scale uses a 6-point Likert scale, and items are summed to create a composite score, with a range of 24-144, higher scores indicating greater burnout. Analyses will focus on a time (baseline, post-intervention, follow-up) by group interaction, and subsequent within group and within timepoint main effects. Here we hypothesize that while there will be a main effect of time, there will be a significant time by group interaction on reducing burnout.

    Change in burnout over 30 day period and 90 day post-intervention follow-up

  • Job Stress

    Evaluated using Job Content Questionnaire. The Job Content Questionnaire is designed to measure the social and psychological characteristics of the workplace environment such as psychological demands, decision latitude, social support, physical demands, and job insecurity. The Job Stress measure will be calculated by combining the Psychological Demands and Decision Latitude subscales. The Psychological Demands subscale is 5-items and the Decision Latitude is 9-items. All are scored on a 1-4 Likert, resulting in a range of 14-56, scored such that higher numbers indicate greater job stress. Analyses will focus on a time (baseline, post-intervention, follow-up) by group interaction, and subsequent within group and within timepoint main effects. Here we hypothesize that while there will be a main effect of time, there will be a significant time by group interaction on reducing job stress.

    Change in job stress over 30 day period and 90 day post-intervention follow-up

  • Job Satisfaction

    Evaluated using Job Satisfaction Questionnaire. This is a 10-item scale, each item scored on a 1-5 Likert scale, resulting in a range of 10-50, with higher scores indicating greater job satisfaction as follows: * 10-26: very low satisfaction * 27-31: low satisfaction * 32-38: average satisfaction * 39-41: high satisfaction * 42-50: very high satisfaction Analyses will focus on a time (baseline, post-intervention, follow-up) by group interaction, and subsequent within group and within timepoint main effects. Here we hypothesize that while there will be a main effect of time, there will be a significant time by group interaction on increasing job satisfaction.

    Change in job satisfaction over 30 day period.

  • Work Life Conflict

    Evaluated using Work Life Conflict Scale.The Work Life Conflict designed to measure conflict between work and non-work experiences. The 5-item measure has been used in previous work, and participants respond to each item using a 1-7 Likert scale with higher numbers indicating greater work-life conflict. Some previous work has averaged responses to the 5-items, thus resulting in a range of 1-7 for this scale. Analyses will focus on a time by group interaction, and subsequent within group and within timepoint main effects. Here we hypothesize that while there will be a main effect of time, there will be a significant time by group interaction on reducing work-life conflict.

    Change in work-life conflict over 30 day period.

  • Life Work Conflict

    Evaluated using Life Work Conflict Scales.The Life Work Conflict designed to measure conflict between non-work experiences and the individual's experiences at work. The 5-item measure has been used in previous work, and participants respond to each item using a 1-7 Likert scale with higher numbers indicating greater life-work conflict. Some previous work has averaged responses to the 5-items, thus resulting in a range of 1-7 for this scale. Analyses will focus on a time by group interaction, and subsequent within group and within timepoint main effects. Here we hypothesize that while there will be a main effect of time, there will be a significant time by group interaction on reducing life-work conflict.

    Change in life-work conflict over 30 day period.

  • Number of Sick Days taken

    Evaluated by asking at 2-month post-intervention follow-up. Analyses will focus on a main effect of group on lower number of sick days taken.

    2-month post-intervention follow-up

  • Functional neural activity to Positive Stimuli

    Functional neural activity to a task displaying positive vs. neutral images. Analyses will focus on a time (baseline, post-intervention) by group (Headspace, Recharge) interaction, and subsequent within group and within timepoint main effects. ROI and connectivity analyses will focus on the reward network. Correlations with changes in included questionnaires and biology will also be assessed.

    Change in functional neural activity over 30 day period.

  • Functional neural activity to Negative Stimuli

    Functional neural activity to a task displaying negative vs. neutral images. Analyses will focus on a time (baseline, post-intervention) by group (Headspace, Recharge) interaction, and subsequent within group and within timepoint main effects. ROI and connectivity analyses will focus on the threat/salience network. Correlations with changes in included questionnaires and biology will also be assessed.

    Change in functional neural activity over 30 day period.

  • Resting state functional connectivity

    Resting state functional connectivity will also be assessed using a time by group interaction and time and group main effects. We will conduct analyses focusing on the default mode and frontostriatal networks. Correlations with changes in included questionnaires and biology will also be assessed.

    Change in resting state functional connectivity over 30 day period.

  • Diffusion Spectrum Imaging (DSI): Assess change in brain white matter tracts

    Diffusion spectrum analyses will include time x group changes in white matter using fractional anisotropy (FA). Analyses will focus on whole brain FA (i.e., white matter integrity across the whole brain). Further analyses will explore associations between changes in white matter and our other outcomes of interest (behavior, biology, affect, functional task performance, etc.).

    Change in white matter integrity over 30 day period.

  • Changes in Amygdala Volume

    Structural changes in the amygdala will also be assessed using time by group interaction and time and group main effects. Voxel based morphometry techniques will be used. In particular, change in gray matter volume will also be correlated with our relevant outcomes to assess whether changes in structure are associated with important changes in behavior, biology or affect.

    Change in amygdala volume over 30 day period.

  • Changes in Reward Network Volume

    Structural changes in the reward network will also be assessed using time by group interaction and time and group main effects. Voxel based morphometry techniques will be used. In particular, these changes in gray matter volume will also be correlated with our relevant outcomes to assess whether changes in structure are associated with important changes in behavior, biology or affect.

    Change in brain volume over 30 day period.

  • Inflammatory Gene Expression

    Changes in gene expression will be assessed using a time by group interaction (with time and group main effects also examined as ancillary findings, and in the event a significant time by group interaction is observed, follow-up group-stratified "simple effects" analyses of time effects may also be conducted to help interpret results). Analyses will focus an a priori-specified gene regulation pattern involving increased expression of inflammation-related genes and decreased expression of antiviral gene - a pattern called the conserved transcriptional response to adversity (CTRA).

    Change in gene expression over 30 day period.

  • Daily Diary--Change in self-reported productivity at work

    Measures will be assessed end-of-day ("I was productive at work today." on 1-7 agreement Likert scale). Analyses will use multilevel modeling to explore differences between groups. Here, we will explore a possible time by group interaction on increased productivity.

    Assessed daily to assess change in self-reported productivity during 30 day intervention

  • Daily Diary--Change in self-reported engagement in meaningful activities at work

    Measures will be assessed end-of-day ("I feel like I did something meaningful at work today." on 1-7 agreement Likert scale). Analyses will use multilevel modeling to explore differences between groups. Here, we will explore a possible time by group interaction on increased self-reports of meaningful activities at work.

    Assessed daily to assess change in engagement of meaningful activities during 30 day intervention

  • Daily Diary--Change in self-reported attention at work

    Measures will be assessed end-of-day ("At work today, I found myself doing things without really paying attention." adapted from Mindful Attention and Awareness Scale, answered on 1-6 frequency scale). Analyses will use multilevel modeling to explore differences between groups. Here, we will explore a possible time by group interaction on increased attention at work.

    Assessed daily to assess change in self-reported attention at work during 30 day intervention

  • Daily Diary--Interpersonal conflict with customers and coworkers

    Interpersonal conflict with customers and coworkers will be assessed by the following questions (1-"none at all" to 5-"a great deal" scale): * How much conflict did you experience with customers today? * How much conflict with coworkers and managers/supervisors did you experience today? These items were selected to capture the listed outcome measure and do not come from a previously used scale. The outcome measure will be assessed end-of-day during the 30 day period. Analyses will use multilevel modeling to explore differences between groups. Here, we will explore a possible time by group interaction on reduced interpersonal conflict with customers and coworkers.

    Assessed daily to assess change in interpersonal conflict during 30 day intervention

  • Daily Diary--Change in perceived stress at work

    Measures will be assessed end-of-day using three items from Perceived Stress Scale adapted for work. Answered on a 0-never to 4-very often scale, with higher scores indicating greater perceived stress at work. Analyses will use multilevel modeling to explore differences between groups. We hypothesize a main effect of time, and a possible time by group interaction effect on perceived stress.

    Assessed daily to assess change in perceived stress during 30 day intervention

Secondary Outcomes (9)

  • Perceived Stress

    Change in perceived stress over 30 day period.

  • Self-reported physical health

    Change in self-reported physical over 30 day period.

  • Self-reported depressive symptoms

    Change in self-reported depressive symptoms over 30 day period.

  • Mindfulness

    Change in mindfulness over 30 day period.

  • Social Support Perceptions

    Change in social support perceptions over 30 day period.

  • +4 more secondary outcomes

Other Outcomes (10)

  • Daily Diary--Positive Affect

    Assessed daily during 30 day intervention

  • Daily Diary--Negative Affect

    Assessed daily during 30 day intervention

  • Daily Diary--Self-reported feelings about work shift

    Assessed daily during 30 day intervention

  • +7 more other outcomes

Study Arms (2)

Headspace

ACTIVE COMPARATOR

30-day smartphone based mindfulness training intervention consisting of 10-minutes for the first 10 days, 15 minutes for the next 10 days, and 20 minutes for the final 10 days.

Behavioral: Mindfulness Training

Recharge

ACTIVE COMPARATOR

30-day smartphone based reflection and problem solving training intervention consisting of 10-minutes for the first 10 days, 15 minutes for the next 10 days, and 20 minutes for the final 10 days.

Behavioral: Reflection and Problem Solving

Interventions

Guided mindfulness meditation and stress management training

Headspace

Guided reflection,problem solving,and analytical thinking training

Recharge

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent in English
  • years old
  • Planning to remain in the Pittsburgh area for the duration of participation
  • Endorse significant work stress

You may not qualify if:

  • Any significant mental and physical health conditions
  • Metal implants
  • Significant claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (16)

  • Slutsky J, Chin B, Raye J, Creswell JD. Mindfulness training improves employee well-being: A randomized controlled trial. J Occup Health Psychol. 2019 Feb;24(1):139-149. doi: 10.1037/ocp0000132. Epub 2018 Oct 18.

    PMID: 30335419BACKGROUND
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND
  • Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.

    PMID: 7431205BACKGROUND
  • Wegner DM, Zanakos S. Chronic thought suppression. J Pers. 1994 Dec;62(4):616-40. doi: 10.1111/j.1467-6494.1994.tb00311.x.

    PMID: 7861307BACKGROUND
  • Singh, J., Goolsby, J. R., & Rhoads, G. K. (1994). Behavioral and psychological consequences of boundary spanning burnout for customer service representatives. Journal of Marketing Research, 558-569.

    BACKGROUND
  • Schnall PL, Schwartz JE, Landsbergis PA, Warren K, Pickering TG. A longitudinal study of job strain and ambulatory blood pressure: results from a three-year follow-up. Psychosom Med. 1998 Nov-Dec;60(6):697-706. doi: 10.1097/00006842-199811000-00007.

    PMID: 9847028BACKGROUND
  • Macdonald, S., & Maclntyre, P. (1997). The generic job satisfaction scale: Scale development and its correlates. Employee Assistance Quarterly, 13(2), 1-16.

    BACKGROUND
  • Waumsley, J. A., Houston, D. M., & Marks, G. (2010). What about us? Measuring the work- life balance of people who do not have children. Review of European Studies , 2(2), 3- 17.

    BACKGROUND
  • Cole SW, Conti G, Arevalo JM, Ruggiero AM, Heckman JJ, Suomi SJ. Transcriptional modulation of the developing immune system by early life social adversity. Proc Natl Acad Sci U S A. 2012 Dec 11;109(50):20578-83. doi: 10.1073/pnas.1218253109. Epub 2012 Nov 26.

    PMID: 23184974BACKGROUND
  • Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

    PMID: 12703651BACKGROUND
  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PMID: 8628042BACKGROUND
  • Radloff, L.S. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1977.

    BACKGROUND
  • Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

    PMID: 16443717BACKGROUND
  • Cutrona, C. E., & Russell, D. W. (1987). The provisions of social relationships and adaptation to stress. Advances in personal relationships, 1(1), 37-67.

    BACKGROUND
  • Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and validation of a self-report measure. Motivation and Emotion, 29(2), 83-102.

    BACKGROUND
  • Cardaciotto L, Herbert JD, Forman EM, Moitra E, Farrow V. The assessment of present-moment awareness and acceptance: the Philadelphia Mindfulness Scale. Assessment. 2008 Jun;15(2):204-23. doi: 10.1177/1073191107311467. Epub 2008 Jan 9.

    PMID: 18187399BACKGROUND

MeSH Terms

Conditions

Stress, PsychologicalInflammationOccupational Stress

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and SymptomsOccupational Diseases

Study Officials

  • David Creswell, Ph.D

    Carnegie Mellon University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will remain masked to which program the participant will use. However the experimenter will be helping set up the participants with the app content and thus will not be masked to condition.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

January 15, 2019

Study Start

February 7, 2019

Primary Completion

November 4, 2019

Study Completion

December 31, 2019

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

The research team will share data associated with self-reports (e.g. job satisfaction, stress levels) and gene expression assays. All data and documentation will be de-identified and will be consistent with applicable laws and regulations. Neuroimaging data will be defaced such that no identifiable information remains on the images.When publishers require analyzed data to be available in order to publish manuscripts, those data will be provided by link to the repository. Data will be shared via KiltHub, a comprehensive repository hosted by Carnegie Mellon University. Data will be shared when a publisher requests that information be shared as part of the terms of publication. A file containing all variables necessary to replicate the analyses from the manuscript will be uploaded. If neuroimaging data is to be shared, the relevant scan will be shared after being de-identified, in addition to the necessary structural scan (as it is required for preprocessing co-registration).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Study data will become available when journals ask for these items upon publication of a paper from this dataset.
Access Criteria
Data relevant to replicating analyses will be shared via KiltHub, a comprehensive repository hosted by Carnegie Mellon University. This repository helps keep track of who has accessed data, and is supported by the university and thus be available to other researchers.

Locations