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Completed

NCT Number: 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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms Burnout, Psychological Helping Behavior Occupational Diseases Occupational Stress Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Riverside

Riverside, California, 92521, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Meditation

Behavioral

10 minute a day, 8 week digital meditation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Riverside

Other

Collaborators

  • Headspace Meditation Limited
  • The University of California's Healthy Campus Network
  • University of California, San Francisco

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 4, 2018
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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