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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527303
Recruitment Status : Active, not recruiting
First Posted : May 17, 2018
Last Update Posted : August 26, 2020
Sponsor:
Collaborators:
UCSF Healthy Campus Network
Headspace, Inc
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Stress, Psychological Behavioral Symptoms Behavioral: Meditation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to either digital meditation condition or wait-list control.
Masking: Single (Investigator)
Masking Description: Investigator will be blind to condition throughout data accrual.
Primary Purpose: Treatment
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 : May 16, 2018
Actual Primary Completion Date : December 5, 2019
Estimated Study Completion Date : September 30, 2020

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
Behavioral: Meditation
10 minute per day, 8 week digital meditation

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)


Information from the National Library of Medicine

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): NCT03527303


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
UCSF Healthy Campus Network
Headspace, Inc
Investigators
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Principal Investigator: Aric A Prather, PhD University of California, San Francisco
Principal Investigator: Elissa Epel, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03527303    
Other Study ID Numbers: 17-23717
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only deidentified aggregated data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
stress
health
meditation
mindfulness
employees
job strain
burnout
work
mood
affect
work related stress
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms