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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress, Psychological

Intervention / Treatment
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* Behavioral: Meditation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation Group<br>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 | Behavioral: Meditation<br>* 10 minute a day, 8 week digital meditation<br>|
| No Intervention: Control Group<br>Control group participants will continue their normal activities and not add any form of meditation during the study period. | |

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, health, meditation, mindfulness, employees, job strain, burnout, work, help, mood, affect