The Impact of 8 Weeks of a Digital Meditation Application on Work Stress
Primary Purpose
Stress, Psychological, Behavioral Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
meditation
Sponsored by
About this trial
This is an interventional treatment trial for Stress focused on measuring stress, mindfulness, work related stress, health, meditation
Eligibility Criteria
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)
Sites / Locations
- University of California IrvineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Meditation Group
Wait list control group
Arm Description
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
Waitlist control group participants will continue their normal activities and not add any form of meditation during the study period.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03624348
First Posted
August 7, 2018
Last Updated
April 6, 2021
Sponsor
University of California, Irvine
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03624348
Brief Title
The Impact of 8 Weeks of a Digital Meditation Application on Work Stress
Official Title
The Impact of 8 Weeks of a Digital Meditation Application on Stress and Job Strain in a Heterogeneous University Employee Cohort
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine
Collaborators
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Behavioral Symptoms
Keywords
stress, mindfulness, work related stress, health, meditation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization to either digital meditation condition or wait-list control.
Masking
Investigator
Masking Description
Investigator will be blind to condition throughout data accrual.
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meditation Group
Arm Type
Experimental
Arm Description
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
Arm Title
Wait list control group
Arm Type
No Intervention
Arm Description
Waitlist control group participants will continue their normal activities and not add any form of meditation during the study period.
Intervention Type
Behavioral
Intervention Name(s)
meditation
Intervention Description
10 minute per day, 8 week digital meditation
Primary Outcome Measure Information:
Title
Change in perceived stress score, as determined by the total score on the Perceived Stress Scale
Description
The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Secondary Outcome Measure Information:
Title
Change in job strain, as determined by Siegrist Job Strain Scale
Description
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.
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Title
Change in job overcommitment, as as determined by Siegrist Job Strain Scale
Description
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.
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Title
Change in burnout, as determined by the Bergen Burnout Inventory
Description
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.
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Title
Change in subjective mindfulness, as determined by total score on Mindful Attention Awareness Scale
Description
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.
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
Title
Change in work engagement, as determined by the Utrecht Work Engagement Scale
Description
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.
Time Frame
Baseline to post-intervention, an anticipated average of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John F Hunter, MA
Phone
657-229-3138
Email
stressfreeuci@gmail.com
First Name & Middle Initial & Last Name & Degree
Sarah D Pressman, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Impact of 8 Weeks of a Digital Meditation Application on Work Stress
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