Clinical trial NCT03695627: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: Stress, health, meditation, mindfulness, employees, job strain, burnout, work, help, mood, affect
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
Collaborators: name: The University of California's Healthy Campus Network
name: Headspace Meditation Limited
name: University of California, San Francisco
First posted: 2018-10-04
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in perceived stress score, as determined by the total score on the Perceived Stress Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
Secondary outcomes:
measure: Change in subjective mindfulness, as determined by total score on Mindful Attention Awareness Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Anxiety, as determined by the Generalized Anxiety Disorder Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in burnout, as determined by the Bergen Burnout Inventory
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Sleep quality as determined by the Pittsburgh Sleep Quality Index
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Worry as determined by the Penn State Worry Questionnaire
timeFrame: Baseline, 4 weeks, 8 weeks, 4 months, 1 year
measure: Rumination as assessed by the McIntosh and Martin Rumination Questionnaire
timeFrame: Baseline, 4 weeks, 8 weeks, 4 months, 1 year
measure: Change in work engagement, as determined by the Utrecht Work Engagement Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in job strain, as determined by Siegrist Job Strain Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
Other outcomes:
Locations:
city: Riverside
country: United States
facility: University of California, Riverside
state: California
Study officials:
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