Contemplative Well-being Apps for the Workplace

NCT03452670 | Completed

• 1 other identifier: IRB00088349
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Behavior; Depression; Inflammation

Keywords

Workplace; Applications; Anxiety; Burnout; Meditation; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Change in Incivility in Nursing Education Revised Survey score

  The Incivility in Nursing Education Revised Survey contains 24-items asking students about behaviors they exhibited or witnessed in the past 12 months (for example, "Students made rude gestures or nonverbal behaviors towards others"). Respondents indicate how often these behaviors occurred by selecting from 1 = Never, 2 = Rarely (only once or twice), 3 = Sometimes (approximately once per month), or 4 = Often (more than once per month). Total scores can range from 24 to 96, with higher scores indicating more incivility performed or witnessed.

  Baseline, Week 8

Secondary Outcomes (7)

• Change in School-Burnout Inventory score

  Baseline, Week 8

• Change in Depression score on the Depression Anxiety and Stress Scale (DASS)

  Baseline, Week 8

• Change in Anxiety score on the Depression Anxiety and Stress Scale (DASS)

  Baseline, Week 8

• Change in Empathic Accuracy (EA) Task

  Baseline, Week 8

• Change in gray matter density in the brain stem

  Baseline, Week 8

Study Arms (2)

Active Group

EXPERIMENTAL

Participants in this group will use a contemplative wellness application for 8 weeks.

Behavioral: Active Group

Waitlist Group

OTHER

The waitlist group will receive no intervention during the study but will be able to use the wellness application after completion of the study.

Other: Waitlist Group

Interventions

Active Group BEHAVIORAL

Participants will be provided with a contemplative well-being application (CWA) which will facilitate meditation for 10 minutes daily during the 8 week study period.

Active Group

Waitlist Group OTHER

The waitlist group will be maintained as a control group throughout all assessments and will be provided enrollment in CWA at the end of the 8 week study period.

Waitlist Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University, Wesley Woods Health Center

Atlanta, Georgia, 30329/GA, United States

Location

MeSH Terms

Conditions

Social Behavior; Depression; Inflammation; Anxiety Disorders; Burnout, Psychological

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Stress, Psychological

Study Officials

• Jennifer Mascaro, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded by study ID# during data collection and management.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 2, 2018
• Study Start: June 6, 2016
• Primary Completion: January 15, 2020
• Study Completion: March 11, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)