Clinical trial NCT03803865: 30 Day Mobile App Programs for Stress Management in Customer Service Representatives
Official title: A Randomized Controlled Trial Comparing a 30 Day Mediation App to 30 Day Active Problem Solving App: Stress Management in Customer Service Representatives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Inflammation
Keywords: Job Stress
Mindfulness
Inflammation
Neuroimaging
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: Headspace Meditation Limited
First posted: 2019-01-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Approach: Employees will be given study flyers describing the study and encouraged to call a project hotline to evaluate their study eligibility. Eligible participants will be scheduled for an in-person study baseline and neuroimaging appointment at Carnegie Mellon University where they will provide written informed consent, complete baseline survey measures, provide several drops of blood via a finger prick (Dried Blood Spot (DBS) samples), and complete a 60-minute neuroimaging scan. After completing baseline measures participants will be instructed on how to download and use the Headspace smartphone app, and will be randomly assigned to one of the two programs. Participants will be asked to complete a 7- minute end-of-day daily diary measure each day during the treatment period, which will measure stress, affect, sleep, and workplace perceptions (a text message link will be sent an hour before the participant's standard bedtime each day). The project team will monitor treatment adherence (participants who do not complete a daily practice session will be called and reminded the following day). In the week following the end of the treatment period, participants will be scheduled to come back to Carnegie Mellon for a post-treatment appointment where they will complete the same measures as at baseline (survey measures, DBS, and neuroimaging). Participants will then be debriefed, compensated, and dismissed. Approximately two months after participants complete the 30-day program, we will call them for a 15-minute follow-up call. During this call, participants will answer a few questionnaire items and a brief program evaluation.

Interventions: Participants will be asked to complete one lesson daily for 30- days on the Headspace app; the first ten lessons will be 10 minutes long, the next ten will be 15 minutes long, and the final ten will be 20 minutes long. The mindfulness program will consist of the standard base program offered in Headspace. The Recharge program will consist of problem solving and stress management instruction.

Setting and Participants: David Creswell's Health and Human Performance Laboratory at Carnegie Mellon University will direct this study. Participants will be customer service employees (those who interact with customers daily via phone or in-person interactions) recruited from the Pittsburgh region.

Eligibility criteria: Inclusion Criteria:

Fluent in English

* 18-70 years old
* Planning to remain in the Pittsburgh area for the duration of participation
* Endorse significant work stress

Exclusion Criteria:

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

Primary outcomes:
measure: Burnout
timeFrame: Change in burnout over 30 day period and 90 day post-intervention follow-up
measure: Job Stress
timeFrame: Change in job stress over 30 day period and 90 day post-intervention follow-up
measure: Job Satisfaction
timeFrame: Change in job satisfaction over 30 day period.
measure: Work Life Conflict
timeFrame: Change in work-life conflict over 30 day period.
measure: Life Work Conflict
timeFrame: Change in life-work conflict over 30 day period.
measure: Number of Sick Days taken
timeFrame: 2-month post-intervention follow-up
measure: Functional neural activity to Positive Stimuli
timeFrame: Change in functional neural activity over 30 day period.
measure: Functional neural activity to Negative Stimuli
timeFrame: Change in functional neural activity over 30 day period.
measure: Resting state functional connectivity
timeFrame: Change in resting state functional connectivity over 30 day period.
measure: Diffusion Spectrum Imaging (DSI): Assess change in brain white matter tracts
timeFrame: Change in white matter integrity over 30 day period.
measure: Changes in Amygdala Volume
timeFrame: Change in amygdala volume over 30 day period.
measure: Changes in Reward Network Volume
timeFrame: Change in brain volume over 30 day period.
measure: Inflammatory Gene Expression
timeFrame: Change in gene expression over 30 day period.
measure: Daily Diary--Change in self-reported productivity at work
timeFrame: Assessed daily to assess change in self-reported productivity during 30 day intervention
measure: Daily Diary--Change in self-reported engagement in meaningful activities at work
timeFrame: Assessed daily to assess change in engagement of meaningful activities during 30 day intervention
measure: Daily Diary--Change in self-reported attention at work
timeFrame: Assessed daily to assess change in self-reported attention at work during 30 day intervention
measure: Daily Diary--Interpersonal conflict with customers and coworkers
timeFrame: Assessed daily to assess change in interpersonal conflict during 30 day intervention
measure: Daily Diary--Change in perceived stress at work
timeFrame: Assessed daily to assess change in perceived stress during 30 day intervention
Secondary outcomes:
measure: Perceived Stress
timeFrame: Change in perceived stress over 30 day period.
measure: Self-reported physical health
timeFrame: Change in self-reported physical over 30 day period.
measure: Self-reported depressive symptoms
timeFrame: Change in self-reported depressive symptoms over 30 day period.
measure: Mindfulness
timeFrame: Change in mindfulness over 30 day period.
measure: Social Support Perceptions
timeFrame: Change in social support perceptions over 30 day period.
measure: Loneliness
timeFrame: Change in self-reported loneliness over 30 day period.
measure: Distress Tolerance/Acceptance
timeFrame: Change distress tolerance/acceptance over 30 day period.
measure: Equanimity
timeFrame: Change in equanimity over 30 day period.
measure: C-reactive protein (CRP) levels
timeFrame: Change in C-Reactive Protein levels over 30 day period.
Other outcomes:
measure: Daily Diary--Positive Affect
timeFrame: Assessed daily during 30 day intervention
measure: Daily Diary--Negative Affect
timeFrame: Assessed daily during 30 day intervention
measure: Daily Diary--Self-reported feelings about work shift
timeFrame: Assessed daily during 30 day intervention
measure: Daily Diary--Self-reported positive attitude at work
timeFrame: Assessed daily during 30 day intervention
measure: Daily Diary--Feelings of acceptance at work
timeFrame: Assessed daily during 30 day intervention
measure: Daily Diary- Work-life conflict
timeFrame: Assessed end-of-day during 30 day intervention
measure: Daily Diary- Life-Work conflict
timeFrame: Assessed daily during 30 day intervention
measure: Daily Diary- Number of social interactions at work and outside of work
timeFrame: Assessed daily during 30 day intervention
measure: Daily Diary--Social Connection
timeFrame: Assessed end-of-day during 30 day intervention
measure: Daily Diary--Self-reported number of hours of sleep
timeFrame: Assessed daily during 30 day intervention
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: David Creswell, Ph.D
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Wegner DM, Zanakos S. Chronic thought suppression. J Pers. 1994 Dec;62(4):616-40. doi: 10.1111/j.1467-6494.1994.tb00311.x.
citation: 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.
citation: 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.
citation: Macdonald, S., & Maclntyre, P. (1997). The generic job satisfaction scale: Scale development and its correlates. Employee Assistance Quarterly, 13(2), 1-16.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Radloff, L.S. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1977.
citation: 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.
citation: Cutrona, C. E., & Russell, D. W. (1987). The provisions of social relationships and adaptation to stress. Advances in personal relationships, 1(1), 37-67.
citation: 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.
citation: 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.