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

November 4, 2020 updated by: Kate Sweeny, University of California, Riverside

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

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Riverside, California, United States, 92521
        • University of California, Riverside

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

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
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 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.
Baseline to post-intervention, an anticipated average of 8 weeks
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
Baseline to post-intervention, an anticipated average of 8 weeks
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.
Baseline to post-intervention, an anticipated average of 8 weeks
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
Baseline to post-intervention, an anticipated average of 8 weeks
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
Baseline, 4 weeks, 8 weeks, 4 months, 1 year
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
Baseline, 4 weeks, 8 weeks, 4 months, 1 year
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.
Baseline to post-intervention, an anticipated average of 8 weeks
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.
Baseline to post-intervention, an anticipated average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2018

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

June 20, 2020

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (Actual)

October 4, 2018

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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