The Impact of 8 Weeks of a Digital Meditation Application on Work Stress

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 University of California, Irvine (UCI) employees who report mild to moderate stress. UCI employees will be randomized to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.

Detailed Description
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The aim of this study is to test the effects of a digital meditation intervention in a sample UCI employees who report moderate to high stress. UCI employees will be randomized to either 8-weeks of a digital meditation 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 at least 10 minutes per day for 8 weeks. All study participants will be asked to fill out short (no longer than 25 minutes) questionnaires at baseline, week 4, week 8 (post intervention), and a 4-month follow up period. Among participants who are randomized to the digital meditation intervention, they will also take part in a 1-year follow up. All activities will take place online (via computer or smartphone). Prior to randomization, participants will go through an eligibility screening and complete the baseline questionnaire battery. The entirety of the study is digital and there are no in-person assessments. Adherence will be tracked remotely. The goal is to recruit as many as 2000 participants (1000 per condition).

Official Title
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The Impact of 8 Weeks of a Digital Meditation Application on Stress and Job Strain in a Heterogeneous University Employee Cohort

Conditions
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Stress, Psychological, Behavioral Symptoms

Intervention / Treatment
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* Behavioral: meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You may join if you: Have access to a smartphone or computer every day Are fluent in English Are a UCSF employee Report mild to moderate levels of stress Consent: demonstrate 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: You may not join if you are an experienced meditator or have participated in a formal meditation practice in the last 6 months (defined as once or more per week for a duration of 20 minutes or more at each practice)

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
Interventional Model Description: Randomization to either digital meditation condition or wait-list control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation Group<br>Participants in the intervention group will assigned to a digitally-based meditation intervention (Headspace app- Basics + Stress packs) and asked to use this for at least 10 minutes a day over the course of 8 weeks | Behavioral: meditation<br>* 10 minute per day, 8 week digital meditation<br>|
| No Intervention: Wait list control group<br>Waitlist 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 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 | 
| Change in job overcommitment, as as determined by Siegrist Job Strain Scale | The job overcommitment subscale of the Siegrist Job Strain Scale is comprised of 4 items providing a total score range from 4 to16. A higher total score reflects more job overcommitment. | 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, mindfulness, work related stress, health, meditation