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

• ClinicalTrials.gov Identifier: NCT03624348
• Recruitment Status: Recruiting
• First Posted: August 10, 2018
• Last Update Posted: April 8, 2021
• Sponsor: University of California, Irvine
• Collaborator: University of California, San Francisco
• Information provided by (Responsible Party): University of California, Irvine

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.

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 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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2000 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: September 20, 2018
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: March 2022

Arms and Interventions

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: Wait list control group; Waitlist control group participants will continue their normal activities and not add any form of meditation during the study period.

Outcome Measures

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.

Eligibility Criteria

• 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 6 months (defined as once or more per week for a duration of 20 minutes or more at each practice)

Contacts and Locations

Locations

United States, California

University of California Irvine; Recruiting

Irvine, California, United States, 92697

Contact: John F Hunter, MA 657-229-3138 stressfreeuci@gmail.com

Principal Investigator: Sarah D Pressman, PhD

Sponsors and Collaborators

University of California, Irvine

University of California, San Francisco

More Information

• Responsible Party: University of California, Irvine
• ClinicalTrials.gov Identifier: NCT03624348
• Other Study ID Numbers: HS#2018-4252
• First Posted: August 10, 2018
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Irvine:

stress; mindfulness; work related stress; health; meditation

Additional relevant MeSH terms:

Behavioral Symptoms