NCT03624348

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

3.4 years

First QC Date

August 7, 2018

Last Update Submit

April 6, 2021

Conditions

Keywords

stressmindfulnesswork related stresshealthmeditation

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Irvine

Irvine, California, 92697, United States

RECRUITING

MeSH Terms

Conditions

Behavioral SymptomsOccupational Stress

Interventions

Meditation

Condition Hierarchy (Ancestors)

BehaviorOccupational DiseasesStress, Psychological

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

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

August 7, 2018

First Posted

August 10, 2018

Study Start

September 20, 2018

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations