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Clinical Trials/NCT03652168
NCT03652168
Unknown
Phase 3

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

University of California, Merced1 site in 1 country200 target enrollmentSeptember 1, 2018

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Stress
Sponsor
University of California, Merced
Enrollment
200
Locations
1
Primary Endpoint
10-Item Measure of Stress Perceptions
Last Updated
7 years ago

Overview

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.

Detailed Description

Stress at work has shown to be an important health risk for employees. It is associated with poor mental and physical health including anxiety, depression, sleep disturbances, gastrointestinal problems, type 2 diabetes, and cardiovascular disease. Work stress also has major implications for employers as evidence suggests that high levels of work stress predict employee burnout, turnover intent, absenteeism, and poor job performance. Mindfulness and its positive effects on a variety of outcomes, including stress reduction, have been documented in many studies. The most common definition of mindfulness is as the state of being attentive to and aware of the present moment with an attitude of openness and acceptance. Several mechanisms by which mindfulness exerts its positive effects have been proposed in the literature including cultivating the attitude of non-judgement and acceptance, ability to observe one's experiences objectively without reacting to them, and ability to be more patient and kind toward oneself. Recent evidence suggests that teaching mindfulness in the workplace not only reduces stress but also improve psychological well-being. With advances in technology, technology-based delivery of many interventions has become popular. App-based treatments for improving psychological health are becoming increasingly important due to high accessibility and cost-effectiveness of smartphone technology. Despite a great number of app-based interventions, there has been little research evaluating their efficacy. Support for the use of smartphone app-based mindfulness interventions comes from a few small studies that found these interventions to produce benefits comparable to traditional delivery methods. While app-based interventions offer a convenient alternative to traditional delivery methods as well as promising initial empirical evidence, more research is needed in order to further evaluate and promote these interventions. The proposed study has several goals. The first goal is to investigate the effects of the app-based mindfulness intervention on overall physical and psychological health (e.g., perceived stress, mindfulness, sleep quality, self-reported health, anxiety symptoms). The second goal is to examine the effect of the intervention on a variety of work-related outcomes (e.g., work stress, job satisfaction, work-related burnout). Further, the study will examine potential mindfulness mechanisms that may drive these effects (e.g., acceptance, reactivity, decentering).

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
August 31, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew Zawadzki

Assistant Professor

University of California, Merced

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

10-Item Measure of Stress Perceptions

Time Frame: Change from Baseline Stress Perceptions at 12 months

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.

Secondary Outcomes

  • 19-Item Measure of Sleep Quality(Change from Baseline Sleep Quality at 8 weeks)
  • 5-Item Work-Family Balance Measure of emotional, behavioral and time demands of both paid work and family (if relevant) or personal duties.(Change from Baseline Work-family Balance at 12 months)
  • 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)
  • Resting Heart Rate(Change from Baseline Resting Heart Rate at 8 weeks)
  • 12-Item Subjective Mental and Physical Well-Being Ratings(Change from Baseline Self-reported health at 8 weeks)
  • 1-Item Measure of Leisure Physical Activity(Change from Baseline Physical Activity at 8 weeks)
  • 3-Item Job Satisfaction Measure(Change from Job Satisfaction at 12 months)

Study Sites (1)

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