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

Primary Purpose

Stress, Psychological, Behavioral Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring stress, health, meditation, mindfulness, employees, job strain, burnout, work, mood, affect, work related stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Meditation Group

Waitlist 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

First Posted
April 25, 2018
Last Updated
November 17, 2020
Sponsor
University of California, San Francisco
Collaborators
UCSF Healthy Campus Network, Headspace, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03527303
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
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
September 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
UCSF Healthy Campus Network, Headspace, Inc

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 UCSF employees who report mild to moderate 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.
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).

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, health, meditation, mindfulness, employees, job strain, burnout, work, mood, affect, work related stress

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
1458 (Actual)

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
Waitlist 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 3 months (defined as 3 times per week or more for 10 minutes or more at each practice)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aric A Prather, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elissa Epel, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only deidentified aggregated data

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

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