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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Kate Sweeny，University of California, Riverside

Tracking Information

First Submitted Date ^ICMJE

July 12, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

July 13, 2018

Estimated Primary Completion Date

December 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.
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
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.
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
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
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
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.
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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:Investigator will be blind to condition throughout data accrual.
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 30, 2019

Estimated Primary Completion Date

December 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Kate Sweeny，University of California, Riverside

Study Sponsor ^ICMJE

University of California, Riverside

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

University of California, Riverside

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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