Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03695627
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborators:
Healthy Campus Network, University of California
Headspace Meditation Limited
University of California, San Francisco
Information provided by (Responsible Party):
Kate Sweeny, University of California, Riverside

Brief 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.


Condition or disease Intervention/treatment Phase
Stress, Psychological Behavioral: Meditation Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Investigator will be blind to condition throughout data accrual.
Primary Purpose: Treatment
Official Title: Stress Free UCR: The Impact of 8 Weeks of Headspace on Stress in a Heterogeneous University Employee Cohort
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

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

No Intervention: Control Group
Control group participants will continue their normal activities and not add any form of meditation during the study period.



Primary Outcome Measures :
  1. 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 ]
    The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress


Secondary Outcome Measures :
  1. 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.

  2. Anxiety, as determined by the Generalized Anxiety Disorder Scale [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
    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

  3. Change in burnout, as determined by the Bergen Burnout Inventory [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
    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.

  4. Sleep quality as determined by the Pittsburgh Sleep Quality Index [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
    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

  5. Worry as determined by the Penn State Worry Questionnaire [ Time Frame: Baseline, 4 weeks, 8 weeks, 4 months, 1 year ]
    The Penn State Worry Questionnaire is a 16-item measure with total scores ranging from 16-60, and higher scores indicating more worry

  6. Rumination as assessed by the McIntosh and Martin Rumination Questionnaire [ Time Frame: Baseline, 4 weeks, 8 weeks, 4 months, 1 year ]
    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

  7. Change in work engagement, as determined by the Utrecht Work Engagement Scale [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
    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.

  8. Change in job strain, as determined by Siegrist Job Strain Scale [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695627


Contacts
Layout table for location contacts
Contact: Kate Sweeny, PhD 3522629582 ksweeny@ucr.edu

Locations
Layout table for location information
United States, California
University of California, Riverside Recruiting
Riverside, California, United States, 92521
Contact: Kate Sweeny    352-262-9582    ksweeny@ucr.edu   
Sponsors and Collaborators
University of California, Riverside
Healthy Campus Network, University of California
Headspace Meditation Limited
University of California, San Francisco

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
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
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

Layout table for additonal information
Responsible Party: Kate Sweeny, Professor of Psychology, University of California, Riverside
ClinicalTrials.gov Identifier: NCT03695627     History of Changes
Other Study ID Numbers: HS-18-031
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kate Sweeny, University of California, Riverside:
Stress, health, meditation, mindfulness, employees, job strain, burnout, work, help, mood, affect
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress, Psychological
Behavioral Symptoms