NCT03527303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,458

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

May 16, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

April 25, 2018

Last Update Submit

November 17, 2020

Conditions

Stress, PsychologicalBehavioral Symptoms

Keywords

stresshealthmeditationmindfulnessemployeesjob strainburnoutworkmoodaffectwork related stress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in job strain, as determined by Siegrist Job Strain Scale

    Baseline to post-intervention, an anticipated average of 8 weeks

  • Change in job overcommitment, as as determined by Siegrist Job Strain Scale

    Baseline to post-intervention, an anticipated average of 8 weeks

  • Change in burnout, as determined by the Bergen Burnout Inventory

    Baseline to post-intervention, an anticipated average of 8 weeks

  • Change in subjective mindfulness, as determined by total score on Mindful Attention Awareness Scale

    Baseline to post-intervention, an anticipated average of 8 weeks

  • Change in work engagement, as determined by the Utrecht Work Engagement Scale

    Baseline to post-intervention, an anticipated average of 8 weeks

Study Arms (2)

Meditation Group

EXPERIMENTAL

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

Waitlist Control Group

NO INTERVENTION

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

Interventions

MeditationBEHAVIORAL

10 minute per day, 8 week digital meditation

Meditation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (1)

  • Radin RM, Vacarro J, Fromer E, Ahmadi SE, Guan JY, Fisher SM, Pressman SD, Hunter JF, Sweeny K, Tomiyama AJ, Hofschneider LT, Zawadzki MJ, Gavrilova L, Epel ES, Prather AA. Digital Meditation to Target Employee Stress: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2454435. doi: 10.1001/jamanetworkopen.2024.54435.

    PMID: 39808431DERIVED

MeSH Terms

Conditions

Stress, PsychologicalBehavioral SymptomsOccupational StressBurnout, Psychological

Interventions

Meditation

Condition Hierarchy (Ancestors)

BehaviorOccupational Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Aric A Prather, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Elissa Epel, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigator will be blind to condition throughout data accrual.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization to either digital meditation condition or wait-list control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 17, 2018

Study Start

May 16, 2018

Primary Completion

December 5, 2019

Study Completion

September 22, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Only deidentified aggregated data

Locations

US(1)