The Impact of 8 Weeks of a Digital Meditation Application on Work Stress
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|ClinicalTrials.gov Identifier: NCT03624348|
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : February 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stress Psychological Behavioral Symptoms||Behavioral: meditation||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomization to either digital meditation condition or wait-list control.|
|Masking Description:||Investigator will be blind to condition throughout data accrual.|
|Official Title:||The Impact of 8 Weeks of a Digital Meditation Application on Stress and Job Strain in a Heterogeneous University Employee Cohort|
|Actual Study Start Date :||September 20, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Meditation Group
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
10 minute per day, 8 week digital meditation
No Intervention: Wait list control group
Waitlist control group participants will continue their normal activities and not add any form of meditation during the study period.
- 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
- 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.
- Change in job overcommitment, as as determined by Siegrist Job Strain Scale [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624348
|United States, California|
|University of California Irvine||Recruiting|
|Irvine, California, United States, 92697|
|Contact: John F Hunter, MA 657-229-3138 email@example.com|
|Principal Investigator: Sarah D Pressman, PhD|