Contemplative Well-being Apps for the Workplace

Depression Clinical Trial

Official title:

Contemplative Well-being Apps for the Workplace

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452670
• Other study ID #: IRB00088349
• Status: Completed
• Phase: N/A
• Start date: June 6, 2016
• Est. completion date: March 11, 2020

Study information

• Verified date: April 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 11, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Inflammation
• Social Behavior

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Emory University, Wesley Woods Health Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, Week 8
Secondary	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.	Baseline, Week 8
Secondary	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.	Baseline, Week 8
Secondary	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.	Baseline, Week 8
Secondary	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.	Baseline, Week 8
Secondary	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.	Baseline, Week 8
Secondary	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.	Baseline, Week 8