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Contemplative Well-being Apps for the Workplace

Primary Purpose

Social Behavior, Depression, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Group
Waitlist Group
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Social Behavior focused on measuring Workplace, Applications, Anxiety, Burnout, Meditation, Mindfulness

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Emory University, Wesley Woods Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Active Group

Waitlist Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in School-Burnout Inventory score
The School-Burnout Inventory is a 9-item survey asking students about how much burnout they have felt in the past month (for example, "I feel overwhelmed by my schoolwork"). Respondents indicate the degree to which they agree with each statement on a scale of 1 to 6 where 1 = completely disagree and 6 = completely agree. Total scores can range from 9 to 54, with higher scores indicating more burnout.
Change in Depression score on the Depression Anxiety and Stress Scale (DASS)
The Depression Anxiety and Stress Scale (DASS) is a 42-item survey asking about feelings of depression and anxiety that the respondent has experienced in the past week (for example, "I found myself getting upset at quite trivial things"). Respondents indicate the degree to which they agree with each statement on a scale of 0 to 3 where 0 = does not apply to me at all and 3 = applied to me very much, or most of the time. The depression subscale includes 14 items. A score of 0-9 indicates no depression, 10-13 indicates moderate depression, 14-20 is moderate depression, 21-27 is severe depression and scores of 28 and above indicate extremely severe depression.
Change in Anxiety score on the Depression Anxiety and Stress Scale (DASS)
The Depression Anxiety and Stress Scale (DASS) is a 42-item survey asking about feelings of depression and anxiety that the respondent has experienced in the past week. Respondents indicate the degree to which they agree with each statement on a scale of 0 to 3 where 0 = does not apply to me at all and 3 = applied to me very much, or most of the time. The depression subscale includes 14 items. A score of 0-7 indicates no anxiety, 8-9 indicates moderate anxiety, 10-14 is moderate anxiety, 15-19 is severe anxiety and scores of 20 and above indicate extremely severe anxiety.
Change in Empathic Accuracy (EA) Task
The Empathic Accuracy (EA) Task is a dynamic video assessment that asks participants to continuously rate the emotions of others as they tell emotional autobiographical stories. Empathic accuracy is the correlation between feelings of the story-tellers in the video and what the participants perceive the story-tellers feelings to be.
Change in gray matter density in the brain stem
The researchers will acquire a high-resolution T1-weighted MRI scan of the whole brain and brain stem from vertex to approximately 2.5 cm below the lower rim of the cerebellum. Gray matter density in the brain stem, with particular focus on the dorsal motor nucleus of vagus nerve and the nucleus of the solitary tract will be measured.
Change in white matter density in the brain stem
The researchers will acquire a high-resolution T1-weighted MRI scan of the whole brain and brain stem from vertex to approximately 2.5 cm below the lower rim of the cerebellum. White matter density in the brain stem, with particular focus on the dorsal motor nucleus of vagus nerve and the nucleus of the solitary tract will be measured.
Change in Gene (mRNA) expression in peripheral blood mononuclear cells (PBMCs)
Gene (mRNA) expression in PBMCs, focusing on a profile of genes with known involvement in immune function, will be analyzed using the Illumina Human HT-12 BeadArrays.

Full Information

First Posted
February 13, 2018
Last Updated
April 9, 2020
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03452670
Brief Title
Contemplative Well-being Apps for the Workplace
Official Title
Contemplative Well-being Apps for the Workplace
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2016 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
March 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Behavior, Depression, Inflammation
Keywords
Workplace, Applications, Anxiety, Burnout, Meditation, Mindfulness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants will be blinded by study ID# during data collection and management.
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Experimental
Arm Description
Participants in this group will use a contemplative wellness application for 8 weeks.
Arm Title
Waitlist Group
Arm Type
Other
Arm Description
The waitlist group will receive no intervention during the study but will be able to use the wellness application after completion of the study.
Intervention Type
Behavioral
Intervention Name(s)
Active Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waitlist Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Incivility in Nursing Education Revised Survey score
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change in School-Burnout Inventory score
Description
The School-Burnout Inventory is a 9-item survey asking students about how much burnout they have felt in the past month (for example, "I feel overwhelmed by my schoolwork"). Respondents indicate the degree to which they agree with each statement on a scale of 1 to 6 where 1 = completely disagree and 6 = completely agree. Total scores can range from 9 to 54, with higher scores indicating more burnout.
Time Frame
Baseline, Week 8
Title
Change in Depression score on the Depression Anxiety and Stress Scale (DASS)
Description
The Depression Anxiety and Stress Scale (DASS) is a 42-item survey asking about feelings of depression and anxiety that the respondent has experienced in the past week (for example, "I found myself getting upset at quite trivial things"). Respondents indicate the degree to which they agree with each statement on a scale of 0 to 3 where 0 = does not apply to me at all and 3 = applied to me very much, or most of the time. The depression subscale includes 14 items. A score of 0-9 indicates no depression, 10-13 indicates moderate depression, 14-20 is moderate depression, 21-27 is severe depression and scores of 28 and above indicate extremely severe depression.
Time Frame
Baseline, Week 8
Title
Change in Anxiety score on the Depression Anxiety and Stress Scale (DASS)
Description
The Depression Anxiety and Stress Scale (DASS) is a 42-item survey asking about feelings of depression and anxiety that the respondent has experienced in the past week. Respondents indicate the degree to which they agree with each statement on a scale of 0 to 3 where 0 = does not apply to me at all and 3 = applied to me very much, or most of the time. The depression subscale includes 14 items. A score of 0-7 indicates no anxiety, 8-9 indicates moderate anxiety, 10-14 is moderate anxiety, 15-19 is severe anxiety and scores of 20 and above indicate extremely severe anxiety.
Time Frame
Baseline, Week 8
Title
Change in Empathic Accuracy (EA) Task
Description
The Empathic Accuracy (EA) Task is a dynamic video assessment that asks participants to continuously rate the emotions of others as they tell emotional autobiographical stories. Empathic accuracy is the correlation between feelings of the story-tellers in the video and what the participants perceive the story-tellers feelings to be.
Time Frame
Baseline, Week 8
Title
Change in gray matter density in the brain stem
Description
The researchers will acquire a high-resolution T1-weighted MRI scan of the whole brain and brain stem from vertex to approximately 2.5 cm below the lower rim of the cerebellum. Gray matter density in the brain stem, with particular focus on the dorsal motor nucleus of vagus nerve and the nucleus of the solitary tract will be measured.
Time Frame
Baseline, Week 8
Title
Change in white matter density in the brain stem
Description
The researchers will acquire a high-resolution T1-weighted MRI scan of the whole brain and brain stem from vertex to approximately 2.5 cm below the lower rim of the cerebellum. White matter density in the brain stem, with particular focus on the dorsal motor nucleus of vagus nerve and the nucleus of the solitary tract will be measured.
Time Frame
Baseline, Week 8
Title
Change in Gene (mRNA) expression in peripheral blood mononuclear cells (PBMCs)
Description
Gene (mRNA) expression in PBMCs, focusing on a profile of genes with known involvement in immune function, will be analyzed using the Illumina Human HT-12 BeadArrays.
Time Frame
Baseline, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Mascaro, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University, Wesley Woods Health Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329/GA
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Contemplative Well-being Apps for the Workplace

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