Stress Free UC Merced: The Effect of 8 Weeks of Mindfulness App Headspace on Stress in a Sample of University Employees

NCT03652168 | Unknown Phase 3

• 1 other identifier: UCM2018-9
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of the app-based mindfulness intervention (i.e., the commercially available application Headspace) on overall physical and psychological health. Secondly, this study examines potential mindfulness mechanisms that may be driving these effects (i.e., decentering, attention regulation, acceptance, self-compassion, reactivity, exposure). This study will randomize UC Merced employees to 8-weeks of either a digital mindfulness intervention (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 questionnaires at baseline, week 4, week 8 (post intervention), 4-month, and 12-month follow up period (20-30 minutes each time). In addition, participants will be asked to complete surveys on their phone as a part of everyday life assessments (4 days per week during baseline, 2 weeks, 5 weeks, 8 weeks, up to 5-10 minutes a day). Participants will also wear a fitness watch, Fitbit, to assess their activity, sleep, and heart rate data. For the everyday life assessment part, participants will be asked to participate in one of our 60 minutes orientation sessions where you will receive training on using the mobile app and receive a fitness watch that will be collected upon the completion of the study.

Conditions

Stress; Psychological Distress

Keywords

stress; health; mindfulness; employees

Outcome Measures

Primary Outcomes (1)

• 10-Item Measure of Stress Perceptions

  Self-reported stress perceptions over the over the past month. Each item is scored using a 0 (never) and 4 (very often) scale. Items are averaged together such that scores can range from 0 to 40; higher scores indicate higher perceived stress. Total score ranging from 0-13 would be considered low stress. Score ranging from 14-26 would be considered moderate stress. Score ranging from 27-40 would be considered high perceived stress.

  Change from Baseline Stress Perceptions at 12 months

Secondary Outcomes (9)

• 9-Item Measure of Symptoms of Depression and Distress

  Change from Baseline Depression at 12 months

• 7-Item Measure of Symptoms of Anxiety

  Change from Baseline Anxiety at 12 months

• 15-Item Measure of Mindfulness - a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present

  Change from Baseline Mindfulness at 12 months

• 19-Item Measure of Sleep Quality

  Change from Baseline Sleep Quality at 8 weeks

• 1-Item Measure of Leisure Physical Activity

  Change from Baseline Physical Activity at 8 weeks

Study Arms (2)

Meditation Group

EXPERIMENTAL

Headspace application: Participants in the intervention 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

No intervention, control group

NO INTERVENTION

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

Interventions

Meditation BEHAVIORAL

10 minute a day, 8 week digital meditation

Meditation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have access to a smartphone or computer with internet every day
• Are fluent in English
• Are a UC Merced employee
• 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:

• Individuals may not join if they are experienced meditators or have participated in a sitting meditation practice more than twice a week (for 10 minutes or greater) over the last three months.

Sponsors & Collaborators

• University of California, Merced: lead
• The University of California's Healthy Campus Network: collaborator
• Headspace Meditation Limited: collaborator

Study Sites (1)

University of California, Merced

Merced, California, 95343, United States

Location

Related Publications (7)

• Bishop, S. R., Lau, M., Shapiro, S., Carlson, L., Anderson, N. D., Carmody, J., ... & Devins, G. (2004). Mindfulness: A proposed operational definition. Clinical psychology: Science and practice, 11(3), 230-241.

  BACKGROUND

• Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

  PMID: 12703651 BACKGROUND

• Ganster, D. C., & Rosen, C. C. (2013). Work stress and employee health: A multidisciplinary review. Journal of Management, 39(5), 1085-1122.

  BACKGROUND

• Goedhard, R. G., & Goedhard, W. J. (2005, June). Work ability and perceived work stress. In International Congress Series(Vol. 1280, pp. 79-83). Elsevier.

  BACKGROUND

• Jamieson SD, Tuckey MR. Mindfulness interventions in the workplace: A critique of the current state of the literature. J Occup Health Psychol. 2017 Apr;22(2):180-193. doi: 10.1037/ocp0000048. Epub 2016 Sep 19.

  PMID: 27643606 BACKGROUND

• Fairburn CG, Patel V. The impact of digital technology on psychological treatments and their dissemination. Behav Res Ther. 2017 Jan;88:19-25. doi: 10.1016/j.brat.2016.08.012.

  PMID: 28110672 BACKGROUND

• Howells, A., Ivtzan, I., & Eiroa-Orosa, F. J. (2016). Putting the 'app'in happiness: a randomised controlled trial of a smartphone-based mindfulness intervention to enhance wellbeing. Journal of Happiness Studies, 17(1), 163-185.

  BACKGROUND

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Matthew J Zawadzki, PhD

  UC Merced

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew J Zawadzki, PhD

CONTACT

(209) 228-4787; mzawadzki@ucmerced.edu

Larisa Gavrilova, BA

CONTACT

lgavrilova@ucmerced.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The party or parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 29, 2018
• Study Start: September 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

US (1)