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

Stress, Psychological Clinical Trial

Official title:

The Impact of 8 Weeks of a Digital Meditation Application on Stress and Job Strain in a Heterogeneous University Employee Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527303
• Other study ID #: 17-23717
• Status: Completed
• Phase: N/A
• Start date: May 16, 2018
• Est. completion date: September 22, 2020

Study information

• Verified date: November 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1458
• Est. completion date: September 22, 2020
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Behavioral Symptoms
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Headspace, Inc, UCSF Healthy Campus Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	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.	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	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.	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	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.	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	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.	Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	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.	Baseline to post-intervention, an anticipated average of 8 weeks