NCT03695627

Brief Summary

The aim of this study is to test the effects of a digital meditation intervention in a sample of high stress UCR employees. We will randomize UCR employees to 8-weeks of either a digital mindfulness 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 10 minutes per day for 8 weeks. They will be asked to fill out short (no longer than 30 minutes long) questionnaires at baseline, week 4, week 8 (post intervention), and a 4-month follow up period. Participants who are randomized to the digital meditation intervention will also take part in a 1-year follow up. All activities will take place online (via computer or smartphone), and on the participants' own time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

July 13, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

July 12, 2018

Last Update Submit

November 4, 2020

Conditions

Keywords

Stress, health, meditation, mindfulness, employees, job strain, burnout, work, help, mood, affect

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 (8)

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

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

  • Anxiety, as determined by the Generalized Anxiety Disorder 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

  • Sleep quality as determined by the Pittsburgh Sleep Quality Index

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

  • Worry as determined by the Penn State Worry Questionnaire

    Baseline, 4 weeks, 8 weeks, 4 months, 1 year

  • +3 more secondary outcomes

Study Arms (2)

Meditation Group

EXPERIMENTAL

Participants in the meditation group will use a digitally-based mindfulness intervention Headspace app (Basics + Stress packs) will be used for 10 minutes a day over the course of 8 weeks

Behavioral: Meditation

Control Group

NO INTERVENTION

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

Interventions

MeditationBEHAVIORAL

10 minute a 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:

  • Have access to a smartphone or computer every day
  • Are fluent in English
  • Are a UCR employee
  • Have moderate to high levels of stress
  • Consent: demonstrates 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:

  • Experienced meditator or have participated in a formal meditation practice in the last 6 months (defined as 3-4 times or more per week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Riverside

Riverside, California, 92521, United States

Location

Related Publications (12)

  • Ganster, D. C., & Rosen, C. C. (2013). Work stress and employee health. Journal of Management, 39(5), 1085-1122. https://doi.org/10.1177/0149206313475815

    BACKGROUND
  • Goh, J., Pfeffer, J., & Zenios, S. A. (2016). The Relationship Between Workplace Stressors and Mortality and Health Costs in the United States. Management Science, 62(2), 608-628. https://doi.org/10.1287/mnsc.2014.2115

    BACKGROUND
  • Karasek, R. A. (1979). Job Demands, Job Decision Latitude, and Mental Strain: Implications for Job Redesign. Administrative Science Quarterly, 24(2), 285. https://doi.org/10.2307/2392498

    BACKGROUND
  • Landsbergis PA, Dobson M, Koutsouras G, Schnall P. Job strain and ambulatory blood pressure: a meta-analysis and systematic review. Am J Public Health. 2013 Mar;103(3):e61-71. doi: 10.2105/AJPH.2012.301153. Epub 2013 Jan 17.

    PMID: 23327240BACKGROUND
  • Landsbergis PA, Schnall PL, Warren K, Pickering TG, Schwartz JE. Association between ambulatory blood pressure and alternative formulations of job strain. Scand J Work Environ Health. 1994 Oct;20(5):349-63. doi: 10.5271/sjweh.1386.

    PMID: 7863299BACKGROUND
  • Ly KH, Truschel A, Jarl L, Magnusson S, Windahl T, Johansson R, Carlbring P, Andersson G. Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial. BMJ Open. 2014 Jan 9;4(1):e003440. doi: 10.1136/bmjopen-2013-003440.

    PMID: 24413342BACKGROUND
  • Mani M, Kavanagh DJ, Hides L, Stoyanov SR. Review and Evaluation of Mindfulness-Based iPhone Apps. JMIR Mhealth Uhealth. 2015 Aug 19;3(3):e82. doi: 10.2196/mhealth.4328.

    PMID: 26290327BACKGROUND
  • Roeser, R. W., Schonert-Reichl, K. A., Jha, A., Cullen, M., Wallace, L., Wilensky, R., … Harrison, J. (2013). Mindfulness training and reductions in teacher stress and burnout: Results from two randomized, waitlist-control field trials. Journal of Educational Psychology, 105(3), 787-804. https://doi.org/10.1037/a0032093

    BACKGROUND
  • Siegrist J, Starke D, Chandola T, Godin I, Marmot M, Niedhammer I, Peter R. The measurement of effort-reward imbalance at work: European comparisons. Soc Sci Med. 2004 Apr;58(8):1483-99. doi: 10.1016/S0277-9536(03)00351-4.

    PMID: 14759692BACKGROUND
  • The Sainsbury Centre for Mental Health. (2007). Mental Health at Work: Developing the business case (Vol. 8).

    BACKGROUND
  • Virgili, M. (2015). Mindfulness-based interventions reduce psychological distress in working adults: A meta-analysis of intervention studies. Mindfulness, 6(2), 326-337. https://doi.org/10.1007/s12671-013-0264-0

    BACKGROUND
  • Wolever RQ, Bobinet KJ, McCabe K, Mackenzie ER, Fekete E, Kusnick CA, Baime M. Effective and viable mind-body stress reduction in the workplace: a randomized controlled trial. J Occup Health Psychol. 2012 Apr;17(2):246-258. doi: 10.1037/a0027278. Epub 2012 Feb 20.

    PMID: 22352291BACKGROUND

MeSH Terms

Conditions

Stress, PsychologicalOccupational StressBurnout, PsychologicalHelping Behavior

Interventions

Meditation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorOccupational DiseasesSocial Behavior

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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

July 12, 2018

First Posted

October 4, 2018

Study Start

July 13, 2018

Primary Completion

December 30, 2019

Study Completion

June 20, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Locations