Clinical trial NCT03452670: Contemplative Well-being Apps for the Workplace
Official title: Contemplative Well-being Apps for the Workplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Behavior
Depression
Inflammation
Keywords: Workplace
Applications
Anxiety
Burnout
Meditation
Mindfulness
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The waitlist group will be maintained as a control group throughout all assessments and will be provided enrollment in the mindfulness app at the end of the study.
Primary purpose: PREVENTION

Brief summary: The study will examine the use and impact of a meditation app delivered to adult workforce populations facing extreme time demands. Enrollees will be randomized to either app or a wait-list group, and will be assessed in terms of job and daily functioning, well-being, and biomarkers of immune function and stress physiology, and neural structure and function prior to randomization and again at multiple time points after participants commence app engagement. In order to assess efficacy, we will examine the longitudinal changes in all measures in both the mindfulness group, compared to wait-list control group.

Detailed description: Over the last 25 years, research on contemplative practices, a family of practices including mindfulness meditation and yoga, has advanced in domains both clinical and basic, motivated by burgeoning evidence of their efficacy for remediating psychopathology and augmenting well-being and resilience. However, much of this research has examined the effects of scheduled group interventions, delivered in-person by instructors over the course of several weeks. Far less research has looked at the delivery method that is most common and arguably most sustainable for busy adults, namely, smart phone delivered Contemplative Applications (apps) for Well-being (CWAs). The proposed study will examine the use and impact of an app delivered to populations facing extreme time demands.

Eligibility criteria: Inclusion Criteria:

* Emory Healthcare and University employees, Cox Enterprises employees, and Emory students

Exclusion Criteria:

* For students and employees in the biomarker sub-study, participants will be studied only if they pass the Society of Magnetic Resonance Imaging standardized MRI screening protocol (exclusions for ferrous metal in any part of body, such as pacemakers, cochlear implants, surgical clips or metal fragments, serious medical conditions, claustrophobia)

Primary outcomes:
measure: Change in Incivility in Nursing Education Revised Survey score
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change in School-Burnout Inventory score
timeFrame: Baseline, Week 8
measure: Change in Depression score on the Depression Anxiety and Stress Scale (DASS)
timeFrame: Baseline, Week 8
measure: Change in Anxiety score on the Depression Anxiety and Stress Scale (DASS)
timeFrame: Baseline, Week 8
measure: Change in Empathic Accuracy (EA) Task
timeFrame: Baseline, Week 8
measure: Change in gray matter density in the brain stem
timeFrame: Baseline, Week 8
measure: Change in white matter density in the brain stem
timeFrame: Baseline, Week 8
measure: Change in Gene (mRNA) expression in peripheral blood mononuclear cells (PBMCs)
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University, Wesley Woods Health Center
state: Georgia
Study officials:
affiliation: Emory University
name: Jennifer Mascaro, PhD
role: PRINCIPAL_INVESTIGATOR
References: