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Contemplative Well-being Apps for the Workplace

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ClinicalTrials.gov Identifier: NCT03452670
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Mascaro, Emory University

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.

Condition or disease Intervention/treatment Phase
Social Behavior Depression Inflammation Behavioral: Active Group Other: Waitlist Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Participants will be blinded by study ID# during data collection and management.
Primary Purpose: Prevention
Official Title: Contemplative Well-being Apps for the Workplace
Actual Study Start Date : June 6, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Group
Participants in this group will use a contemplative wellness application for 8 weeks.
Behavioral: Active Group
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.

Waitlist Group
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
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 Measures :
  1. Change in Incivility in Nursing Education Revised Survey score [ Time Frame: Baseline, Week 8 ]
    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 :
  1. Change in School-Burnout Inventory score [ Time Frame: Baseline, Week 8 ]
    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.

  2. Change in Depression score on the Depression Anxiety and Stress Scale (DASS) [ Time Frame: Baseline, Week 8 ]
    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.

  3. Change in Anxiety score on the Depression Anxiety and Stress Scale (DASS) [ Time Frame: Baseline, Week 8 ]
    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.

  4. Change in Empathic Accuracy (EA) Task [ Time Frame: Baseline, Week 8 ]
    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.

  5. Change in gray matter density in the brain stem [ Time Frame: Baseline, Week 8 ]
    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.

  6. Change in white matter density in the brain stem [ Time Frame: Baseline, Week 8 ]
    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.

  7. Change in Gene (mRNA) expression in peripheral blood mononuclear cells (PBMCs) [ Time Frame: Baseline, Week 8 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452670


Contacts
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Contact: Jennifer Mascaro, PhD 404-727-4301 jmascar@emory.edu
Contact: Anushree Mahajan anushree.mahajan@emory.edu

Locations
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United States, Georgia
Emory University, Wesley Woods Health Center Recruiting
Atlanta, Georgia, United States, 30329/GA
Contact: Jennifer Mascaro, PhD    404-727-4301    jmascar@emory.edu   
Contact: Anushree Mahajan       anushree.mahajan@emory.edu   
Principal Investigator: Jennifer Mascaro, PhD         
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Jennifer Mascaro, PhD Emory University

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Responsible Party: Jennifer Mascaro, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03452670     History of Changes
Other Study ID Numbers: IRB00088349
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Mascaro, Emory University:
Workplace
Applications
Anxiety
Burnout
Meditation
Mindfulness
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes