- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03527303
The Impact of 8 Weeks of a Digital Meditation Application on Work Stress
The Impact of 8 Weeks of a Digital Meditation Application on Stress and Job Strain in a Heterogeneous University Employee Cohort
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to test the effects of a digital meditation intervention in a sample UCSF employees who report moderate to high stress. We will randomize UCSF employees 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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California
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San Francisco, California, United States, 94118
- University of California, San Francisco
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 3 months (defined as 3 times per week or more for 10 minutes or more at each practice)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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10 minute per day, 8 week digital meditation
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No Intervention: Waitlist Control Group
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?
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
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
|
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
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.
|
Baseline to post-intervention, an anticipated average of 8 weeks
|
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.
|
Baseline to post-intervention, an anticipated average of 8 weeks
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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.
|
Baseline to post-intervention, an anticipated average of 8 weeks
|
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.
|
Baseline to post-intervention, an anticipated average of 8 weeks
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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.
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Baseline to post-intervention, an anticipated average of 8 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Aric A Prather, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-23717
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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