Stress Free UCR: The Impact of 8 Weeks of Headspace on Stress in a Heterogeneous University Employee Cohort
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|ClinicalTrials.gov Identifier: NCT03695627|
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : October 4, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress, Psychological||Behavioral: Meditation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Investigator will be blind to condition throughout data accrual.|
|Official Title:||Stress Free UCR: The Impact of 8 Weeks of Headspace on Stress in a Heterogeneous University Employee Cohort|
|Actual Study Start Date :||July 13, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Experimental: Meditation Group
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
10 minute a day, 8 week digital meditation
No Intervention: Control Group
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 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.
- 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
- 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.
- 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
- 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
- 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
- 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.
- 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.
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): NCT03695627
|Contact: Kate Sweeny, PhDfirstname.lastname@example.org|
|United States, California|
|University of California, Riverside||Recruiting|
|Riverside, California, United States, 92521|
|Contact: Kate Sweeny 352-262-9582 email@example.com|