Stress Free UCR: The Impact of 8 Weeks of Headspace on Stress in a Heterogeneous University Employee Cohort

Stress, Psychological Clinical Trial

Official title:

Stress Free UCR: The Impact of 8 Weeks of Headspace on Stress in a Heterogeneous University Employee Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695627
• Other study ID #: HS-18-031
• Status: Completed
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: June 20, 2020

Study information

• Verified date: November 2020
• Source: University of California, Riverside
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test the effects of a digital meditation intervention in a sample of high stress UCR employees. We will randomize UCR employees to 8-weeks of either a digital mindfulness intervention (using the commercially available application Headspace) or a waitlist control condition.

Participants assigned to the intervention group will be asked to download and use the Headspace mobile application for 10 minutes per day for 8 weeks. They will be asked to fill out short (no longer than 30 minutes long) questionnaires at baseline, week 4, week 8 (post intervention), and a 4-month follow up period. Participants who are randomized to the digital meditation intervention will also take part in a 1-year follow up. All activities will take place online (via computer or smartphone), and on the participants' own time.

Description:

High levels of psychosocial work-related stress have major implications for both the employee and the employer. Epidemiological studies consistently demonstrate associations between high work stress and worse self-reported mental and physical health, including depression, anxiety, cardiovascular disease, and type 2 diabetes.

Job strain, a combination of high demands and low control, is a common model used to define psychosocial stress at work. Job strain is associated with worse mental and physical health, including anxiety and depressive disorders and increased blood pressure.

Past studies show the value in mindfulness applications. For example, participants who completed 25 or more meditation sessions over 8 weeks also had significantly lower self-measured systolic blood pressure over the course of one day compared to the control condition participants at the follow-up time point. This trial suggests that almost daily brief mindfulness meditations delivered via smartphone can improve outcomes related to workplace stress and well-being, with potentially lasting effects.

In this study, investigators hope to determine if a stress-reduction mindfulness application is more effective than a waitlist control condition in employees who are experiencing mild to moderate levels of stress in various health and productivity-related outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: June 20, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have access to a smartphone or computer every day

• Are fluent in English

• Are a UCR employee

• Have moderate to high levels of stress

• Consent: demonstrates understanding of the study and willingness to participate as evidenced by voluntary informed consent and has received a signed and dated copy of the informed consent

• Are at least 18 years of age

Exclusion Criteria:

• Experienced meditator or have participated in a formal meditation practice in the last 6 months (defined as 3-4 times or more per week)

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Behavioral:
• Meditation
10 minute a day, 8 week digital meditation

Locations

Country	Name	City	State
United States	University of California, Riverside	Riverside	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Riverside	Headspace Meditation Limited, University of California Office of the President, Healthy Campus Network, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (12)

Ganster, D. C., & Rosen, C. C. (2013). Work stress and employee health. Journal of Management, 39(5), 1085-1122. https://doi.org/10.1177/0149206313475815

Goh, J., Pfeffer, J., & Zenios, S. A. (2016). The Relationship Between Workplace Stressors and Mortality and Health Costs in the United States. Management Science, 62(2), 608-628. https://doi.org/10.1287/mnsc.2014.2115

Karasek, R. A. (1979). Job Demands, Job Decision Latitude, and Mental Strain: Implications for Job Redesign. Administrative Science Quarterly, 24(2), 285. https://doi.org/10.2307/2392498

Landsbergis PA, Dobson M, Koutsouras G, Schnall P. Job strain and ambulatory blood pressure: a meta-analysis and systematic review. Am J Public Health. 2013 Mar;103(3):e61-71. doi: 10.2105/AJPH.2012.301153. Epub 2013 Jan 17. Review. — View Citation

Landsbergis PA, Schnall PL, Warren K, Pickering TG, Schwartz JE. Association between ambulatory blood pressure and alternative formulations of job strain. Scand J Work Environ Health. 1994 Oct;20(5):349-63. — View Citation

Ly KH, Trüschel A, Jarl L, Magnusson S, Windahl T, Johansson R, Carlbring P, Andersson G. Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial. BMJ Open. 2014 Jan 9;4(1):e003440. doi: 10.1136/bmjopen-2013-003440. — View Citation

Mani M, Kavanagh DJ, Hides L, Stoyanov SR. Review and Evaluation of Mindfulness-Based iPhone Apps. JMIR Mhealth Uhealth. 2015 Aug 19;3(3):e82. doi: 10.2196/mhealth.4328. — View Citation

Roeser, R. W., Schonert-Reichl, K. A., Jha, A., Cullen, M., Wallace, L., Wilensky, R., … Harrison, J. (2013). Mindfulness training and reductions in teacher stress and burnout: Results from two randomized, waitlist-control field trials. Journal of Educational Psychology, 105(3), 787-804. https://doi.org/10.1037/a0032093

Siegrist J, Starke D, Chandola T, Godin I, Marmot M, Niedhammer I, Peter R. The measurement of effort-reward imbalance at work: European comparisons. Soc Sci Med. 2004 Apr;58(8):1483-99. — View Citation

The Sainsbury Centre for Mental Health. (2007). Mental Health at Work: Developing the business case (Vol. 8).

Virgili, M. (2015). Mindfulness-based interventions reduce psychological distress in working adults: A meta-analysis of intervention studies. Mindfulness, 6(2), 326-337. https://doi.org/10.1007/s12671-013-0264-0

Wolever RQ, Bobinet KJ, McCabe K, Mackenzie ER, Fekete E, Kusnick CA, Baime M. Effective and viable mind-body stress reduction in the workplace: a randomized controlled trial. J Occup Health Psychol. 2012 Apr;17(2):246-258. doi: 10.1037/a0027278. Epub 2012 Feb 20. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in perceived stress score, as determined by the total score on the Perceived Stress Scale	The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Change in subjective mindfulness, as determined by total score on Mindful Attention Awareness Scale	The Mindful Attention Awareness Scale is a 15-item measure with each item ranging from a score of 1 to 6. To score the scale, we compute the average score across items, with a higher score reflecting higher levels of mindfulness.	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Anxiety, as determined by the Generalized Anxiety Disorder Scale	The Generalized Anxiety Disorder Scale is a 7-item measure with each item ranging from 0-3, with total scores ranging from 0-21 and higher scores indicating higher anxiety	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Change in burnout, as determined by the Bergen Burnout Inventory	The Bergen Burnout Inventory is comprised of 9 items, ranging from 1 to 6. The total score range is from 9 to 54 with a higher score reflecting higher burnout.	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Sleep quality as determined by the Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index is a 9-item scale with a complex scoring scheme, in which a total score of "5" or greater is indicative of poor sleep quality	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Worry as determined by the Penn State Worry Questionnaire	The Penn State Worry Questionnaire is a 16-item measure with total scores ranging from 16-60, and higher scores indicating more worry	Baseline, 4 weeks, 8 weeks, 4 months, 1 year
Secondary	Rumination as assessed by the McIntosh and Martin Rumination Questionnaire	The McIntosh and Martin Rumination Questionnaire is a 10-item measure with each item scored from 1-5, such that average scores range from 1 to 5 and higher scores indicate more rumination	Baseline, 4 weeks, 8 weeks, 4 months, 1 year
Secondary	Change in work engagement, as determined by the Utrecht Work Engagement Scale	The Utrecht Work Engagement scale is comprised of 9 items, with a total score ranging from 0 to 54, with higher scores indicating more work engagement.	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Change in job strain, as determined by Siegrist Job Strain Scale	The job strain measure is a comprised of two sub scales, effort (5 items) and reward (11 items), each ranging from 1 to 4. The job strain score is calculated as the ratio of demand to reward, with a higher ratio reflecting more job strain.	Baseline to post-intervention, an anticipated average of 8 weeks