Social BehaviorNCT03452670
Contemplative Well-being Apps for the Workplace
A study testing Active Group and Waitlist Group in people with Social Behavior and Depression, run by Emory University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Behavior, Depression, Inflammation
- What is being tested?
- Active Group and Waitlist Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2016to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Emory Healthcare and University employees, Cox Enterprises employees, and Emory students
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University, Wesley Woods Health Center
Atlanta, Georgia, 30329/GA
About this study
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.
Read the 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.
- Conditions
- Social Behavior, Depression, Inflammation
- Being tested
- Active Group, Waitlist Group
- Keywords
- Workplace, Applications, Anxiety, Burnout, Meditation, Mindfulness
- Medical subject headings
- Social Behavior, Depression, Inflammation, Anxiety Disorders, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active GroupBehavioural
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | Participants in this group will use a contemplative wellness application for 8 weeks. Receives: 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. Receives: Other: Waitlist Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8
Secondary outcomes (7)
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start6 Jun 2016
- Primary completion15 Jan 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social BehaviorStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Mascaro, Emory University
- Investigators
- Jennifer Mascaro, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452670
- Sponsor's protocol ID
- IRB00088349
- Status last verified
- Apr 2020
- First submitted
- 13 Feb 2018
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contemplative Well-being Apps for the Workplace
- ClinicalTrials.gov ID
- NCT03452670
- Acronym / sponsor ID
- IRB00088349
- Conditions
- Social Behavior, Depression, Inflammation
- Keywords
- Workplace, Applications, Anxiety, Burnout, Meditation, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Behavioral: Active GroupParticipants in this group will use a contemplative wellness application for 8 weeks. |
| Waitlist Group | Other | Other: Waitlist GroupThe waitlist group will receive no intervention during the study but will be able to use the wellness application after completion of the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Emory Healthcare and University employees, Cox Enterprises employees, and Emory students
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active GroupParticipants will be provided with a contemplative well-being application (CWA) which will facilitate meditation for 10 minutes daily during the 8 week study period. | Behavioural | Active Group |
| Waitlist GroupThe 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. | Other | Waitlist Group |
Primary outcome
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.
7 secondary outcomes
Change in School-Burnout Inventory score
Time frame: Baseline, Week 8
Change in Depression score on the Depression Anxiety and Stress Scale (DASS)
Time frame: Baseline, Week 8
Change in Anxiety score on the Depression Anxiety and Stress Scale (DASS)
Time frame: Baseline, Week 8
Change in Empathic Accuracy (EA) Task
Time frame: Baseline, Week 8
Change in gray matter density in the brain stem
Time frame: Baseline, Week 8
Change in white matter density in the brain stem
Time frame: Baseline, Week 8
Change in Gene (mRNA) expression in peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Mascaro, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Group and Waitlist Group in people with Social Behavior and Depression, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Incivility in Nursing Education Revised Survey score (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.