Clinical trial NCT03652168: Stress Free UC Merced: The Effect of 8 Weeks of Mindfulness App Headspace on Stress in a Sample of University Employees
Official title: Stress Free UC Merced: The Effect of 8 Weeks of Mindfulness App Headspace on Stress in a Sample of University Employees
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stress
Psychological Distress
Keywords: stress
health
mindfulness
employees
Lead sponsor: University of California, Merced
Sponsor class: OTHER
Collaborators: name: The University of California's Healthy Campus Network
name: Headspace Meditation Limited
First posted: 2018-08-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: 10-Item Measure of Stress Perceptions
timeFrame: Change from Baseline Stress Perceptions at 12 months
Secondary outcomes:
measure: 9-Item Measure of Symptoms of Depression and Distress
timeFrame: Change from Baseline Depression at 12 months
measure: 7-Item Measure of Symptoms of Anxiety
timeFrame: Change from Baseline Anxiety at 12 months
measure: 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
timeFrame: Change from Baseline Mindfulness at 12 months
measure: 19-Item Measure of Sleep Quality
timeFrame: Change from Baseline Sleep Quality at 8 weeks
measure: 1-Item Measure of Leisure Physical Activity
timeFrame: Change from Baseline Physical Activity at 8 weeks
measure: Resting Heart Rate
timeFrame: Change from Baseline Resting Heart Rate at 8 weeks
measure: 12-Item Subjective Mental and Physical Well-Being Ratings
timeFrame: Change from Baseline Self-reported health at 8 weeks
measure: 3-Item Job Satisfaction Measure
timeFrame: Change from Job Satisfaction at 12 months
measure: 5-Item Work-Family Balance Measure of emotional, behavioral and time demands of both paid work and family (if relevant) or personal duties.
timeFrame: Change from Baseline Work-family Balance at 12 months
Other outcomes:
Locations:
city: Merced
country: United States
facility: University of California, Merced
state: California
Study officials:
affiliation: UC Merced
name: Matthew J Zawadzki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Goedhard, R. G., & Goedhard, W. J. (2005, June). Work ability and perceived work stress. In International Congress Series(Vol. 1280, pp. 79-83). Elsevier.
citation: 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.
citation: 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.
citation: 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.