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

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation
Sponsored by
University of California, Riverside
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Stress, health, meditation, mindfulness, employees, job strain, burnout, work, help, mood, affect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of California, Riverside

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Meditation Group

Control Group

Arm Description

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

Control group participants will continue their normal activities and not add any form of meditation during the study period.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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.
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
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
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
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.
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.

Full Information

First Posted
July 12, 2018
Last Updated
November 4, 2020
Sponsor
University of California, Riverside
Collaborators
University of California Office of the President, Healthy Campus Network, Headspace Meditation Limited, University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03695627
Brief Title
Stress Free UCR: The Impact of 8 Weeks of Headspace on Stress in a Heterogeneous University Employee Cohort
Official Title
Stress Free UCR: The Impact of 8 Weeks of Headspace on Stress in a Heterogeneous University Employee Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
June 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Riverside
Collaborators
University of California Office of the President, Healthy Campus Network, Headspace Meditation Limited, University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Stress, health, meditation, mindfulness, employees, job strain, burnout, work, help, mood, affect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Investigator will be blind to condition throughout data accrual.
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group participants will continue their normal activities and not add any form of meditation during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Intervention Description
10 minute a day, 8 week digital meditation
Primary Outcome Measure Information:
Title
Change in perceived stress score, as determined by the total score on the Perceived Stress Scale
Description
The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Secondary Outcome Measure Information:
Title
Change in subjective mindfulness, as determined by total score on Mindful Attention Awareness Scale
Description
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.
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Title
Anxiety, as determined by the Generalized Anxiety Disorder Scale
Description
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
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Title
Change in burnout, as determined by the Bergen Burnout Inventory
Description
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.
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Title
Sleep quality as determined by the Pittsburgh Sleep Quality Index
Description
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
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Title
Worry as determined by the Penn State Worry Questionnaire
Description
The Penn State Worry Questionnaire is a 16-item measure with total scores ranging from 16-60, and higher scores indicating more worry
Time Frame
Baseline, 4 weeks, 8 weeks, 4 months, 1 year
Title
Rumination as assessed by the McIntosh and Martin Rumination Questionnaire
Description
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
Time Frame
Baseline, 4 weeks, 8 weeks, 4 months, 1 year
Title
Change in work engagement, as determined by the Utrecht Work Engagement Scale
Description
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.
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Title
Change in job strain, as determined by Siegrist Job Strain Scale
Description
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.
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
University of California, Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92521
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
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Results Reference
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Citation
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
Results Reference
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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
Results Reference
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PubMed Identifier
23327240
Citation
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.
Results Reference
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PubMed Identifier
7863299
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. doi: 10.5271/sjweh.1386.
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PubMed Identifier
24413342
Citation
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PubMed Identifier
26290327
Citation
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Citation
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Stress Free UCR: The Impact of 8 Weeks of Headspace on Stress in a Heterogeneous University Employee Cohort

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