- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03695627
Stress Free UCR: The Impact of 8 Weeks of Headspace on Stress in a Heterogeneous University Employee Cohort
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Riverside, California, United States, 92521
- University of California, Riverside
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Meditation Group
Participants in the meditation group will use a digitally-based mindfulness intervention Headspace app (Basics + Stress packs) will be used for 10 minutes a day over the course of 8 weeks
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10 minute a day, 8 week digital meditation
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No Intervention: Control Group
Control group participants will continue their normal activities and not add any form of meditation during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in perceived stress score, as determined by the total score on the Perceived Stress Scale
Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks
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The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress
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Baseline to post-intervention, an anticipated average of 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in subjective mindfulness, as determined by total score on Mindful Attention Awareness Scale
Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks
|
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.
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Baseline to post-intervention, an anticipated average of 8 weeks
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Anxiety, as determined by the Generalized Anxiety Disorder Scale
Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks
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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
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Baseline to post-intervention, an anticipated average of 8 weeks
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Change in burnout, as determined by the Bergen Burnout Inventory
Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks
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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.
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Baseline to post-intervention, an anticipated average of 8 weeks
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Sleep quality as determined by the Pittsburgh Sleep Quality Index
Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks
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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
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Baseline to post-intervention, an anticipated average of 8 weeks
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Worry as determined by the Penn State Worry Questionnaire
Time Frame: Baseline, 4 weeks, 8 weeks, 4 months, 1 year
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The Penn State Worry Questionnaire is a 16-item measure with total scores ranging from 16-60, and higher scores indicating more worry
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Baseline, 4 weeks, 8 weeks, 4 months, 1 year
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Rumination as assessed by the McIntosh and Martin Rumination Questionnaire
Time Frame: Baseline, 4 weeks, 8 weeks, 4 months, 1 year
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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
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Baseline, 4 weeks, 8 weeks, 4 months, 1 year
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Change in work engagement, as determined by the Utrecht Work Engagement Scale
Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks
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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.
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Baseline to post-intervention, an anticipated average of 8 weeks
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Change in job strain, as determined by Siegrist Job Strain Scale
Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks
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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.
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Baseline to post-intervention, an anticipated average of 8 weeks
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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. doi: 10.5271/sjweh.1386.
- Ly KH, Truschel 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.
- 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.
- 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. doi: 10.1016/S0277-9536(03)00351-4.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-18-031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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