Clinical trial NCT03527303: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Behavioral Symptoms
Keywords: stress
health
meditation
mindfulness
employees
job strain
burnout
work
mood
affect
work related stress
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: The University of California's Healthy Campus Network
name: Headspace, Inc
First posted: 2018-05-17
Enrollment: 1458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to either digital meditation condition or wait-list control.
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Change in perceived stress score, as determined by the total score on the Perceived Stress Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
Secondary outcomes:
measure: Change in job strain, as determined by Siegrist Job Strain Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in job overcommitment, as as determined by Siegrist Job Strain Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in burnout, as determined by the Bergen Burnout Inventory
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in subjective mindfulness, as determined by total score on Mindful Attention Awareness Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in work engagement, as determined by the Utrecht Work Engagement Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Aric A Prather, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Elissa Epel, PhD
role: PRINCIPAL_INVESTIGATOR
References: