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Online Mindfulness Program for Stress Management (IGEM)

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ClinicalTrials.gov Identifier: NCT03753360
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Leonard Calabrese, The Cleveland Clinic

Brief Summary:

This is a prospective parallel non-blinded randomized study with two arms, an intervention group and an active control group.

Sixty healthy, but stressed nurses will be randomly assigned to either participate in a 6-week internet-based mindfulness meditation program produced by the Cleveland Clinic called Stress Free Now for Healers or to listen to relaxing music for at least 5 minutes a day for 6 weeks, and pre-post comparisons will be made for RNA expression profiles, plasma cytokine concentrations, telomerase activity, 6-point salivary cortisol and several self-reported assessments of physical and mental health.


Condition or disease Intervention/treatment Phase
Stress, Psychological Burnout, Professional Behavioral: Internet-Based Mindfulness Program - Stress Free Now for Healers Behavioral: Active Control Group - Relaxing Music Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Parallel non-blinded randomized two arms, intervention group and active control group
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Immunological and Genomic Effects of an Online Mindfulness Program for Stress Management
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Intervention Group
internet-based mindfulness meditation program
Behavioral: Internet-Based Mindfulness Program - Stress Free Now for Healers
Stress Free Now for Healers is an online stress management program developed at Cleveland. It's delivered in 4 components:1Weekly introductions to the concepts and meditation theme are delivered via Web page views or a 5to10-min audio clip2Weekly guided meditations 5-20 min ea.available as embedded/downloadable mp3 on the website or via the Stress Free Now for Healers phone app,which participants are invited to practice at least 4 times each week and to record those practices3Daily articles provide the scientific underpinnings and merits of each week's theme or discuss various cognitive and behavioral strategies,activities,and concepts supporting or related to mindfulness4Daily tips suggesting how to manage stress or incorporate mindfulness in daily activities,including motivational quotes.Participants will have access to a smartphone app with recordings of the 11 guided meditations.Ea. participant will be assigned an e-coach that will communicate with the participant at least weekly.

Active Control Group
relaxing music
Behavioral: Active Control Group - Relaxing Music
The control group will be given a flash drive and a link to a website where they can download several digital recordings of relaxing music and will be instructed to quietly listen to one or more of the recordings for at least 5 minutes every day for 6 weeks.




Primary Outcome Measures :
  1. Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group. [ Time Frame: 6 weeks ]
    Next Generation Sequencing (NGS) will be used to measure whole transcriptome RNA expression in peripheral blood mononuclear cells (PBMCs) of subjects before and after participation in Stress Free Now or the control intervention. This data will then be used to create a pre-post differential expression signature to identify genes that were significantly up- or downregulated across the entire group. The within group changes will then be compared between the intervention and the control group and analyzed for significant differences.

  2. Pre-/post-intervention changes in IL-6 [ Time Frame: 6 weeks ]
    Measure plasma concentrations of IL-6 before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  3. Pre-/post-intervention changes in IL-8 [ Time Frame: 6 weeks ]
    Measure plasma concentrations of IL-8 before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  4. Pre-/post-intervention changes in IL-10 [ Time Frame: 6 weeks ]
    Measure plasma concentrations of IL-10 before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  5. Pre-/post-intervention changes in TNF-α [ Time Frame: 6 weeks ]
    Measure plasma concentrations of TNF-α before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  6. Pre-/post-intervention changes in IFN-γ [ Time Frame: 6 weeks ]
    Measure plasma concentrations of IFN-γ before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  7. Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity [ Time Frame: 6 weeks ]
    Measure telomerase activity in PBMCs before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.


Secondary Outcome Measures :
  1. Pre-/post-intervention changes in salivary cortisol awakening response [ Time Frame: 6 weeks ]
    The pre/post-changes in cortisol awakening response, measured via subject-collected saliva samples immediately upon and 30 minutes after waking, will be compared between groups.

  2. Pre-/post-intervention changes in evening salivary cortisol [ Time Frame: 6 weeks ]
    The pre/post-changes in evening cortisol level, measured via subject-collected saliva samples between 10 PM and 12 AM, will be compared between groups.

  3. Pre-/post-intervention changes in diurnal cortisol slope [ Time Frame: 6 weeks ]
    The pre/post-changes in diurnal cortisol slope, measured via subject-collected saliva samples at 6 time points throughout the day, will be compared between groups.

  4. Pre-/post-intervention changes in perceived stress [ Time Frame: 6 and 12 weeks ]
    The pre/post-changes in perceived stress, measured with a validated survey (Perceived Stress Scale), will be compared between groups. The Perceived Stress Scale is a 10-item scale with a total score ranging between 0 and 40 used to measure of the degree to which situations in one's life are appraised as stressful. A higher score indicates a higher level of perceived stress.

  5. Pre-/post-intervention changes in resilience [ Time Frame: 6 and 12 weeks ]
    The pre/post-changes in psychological resilience, measured with a validated survey (Connor-Davidson Resilience Scale abbreviated version), will be compared between groups. The Connor-Davidson Resilience Scale abbreviated version is 10-item scale that measures psychological resilience using a total score between 0 and 40, with a higher score indicating greater resilience.

  6. Pre-/post-intervention changes in symptoms of burnout [ Time Frame: 6 and 12 weeks ]
    The pre/post-changes in symptoms of professional burnout, measured with a validated survey (Maslach Burnout Inventory - Human Services Survey), will be compared between groups. The Maslach Burnout Inventory - Human Services Survey is the original and most widely used version of the Maslach Burnout Inventory and is designed to measure symptoms of work-related burnout in professionals of human services. It is a 22-item scale that gives a total score ranging between 0 and 132, with higher scores indicating the respondent experiencing more burnout.

  7. Pre-/post-intervention changes in emotional well-being [ Time Frame: 6 and 12 weeks ]
    The pre/post-changes in emotional well-being, measured with a validated survey (RAND 36 - Emotional Well-Being subscale), will be compared between groups.

  8. Pre-/post-intervention changes in self-reported global health [ Time Frame: 6 and 12 weeks ]
    The pre/post-changes in global health, measured with a validated survey (PROMIS Global Health SF), will be compared between groups. The PROMIS Global Health Short Form is a 10-item scale used to assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life, with the total score ranging between 10 and 50, higher scores indicating greater overall health.

  9. Pre-/post-intervention changes in anxiety symptoms [ Time Frame: 6 and 12 weeks ]
    The pre/post-changes in anxiety, measured with a validated survey (PROMIS Anxiety CAT), will be compared between groups. The PROMIS Anxiety CAT is a computer adaptive test that measures anxiety related symptoms. For CATs, the number of items varies between 4 and 12. The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. The CAT will continue until either the standard error drops below a specified level or the participant has answered the maximum number of questions (12), whichever occurs first. The end result is a T-score in which the individual's responses are compared to the U.S. general population, which based on calibration testing has a mean of 50 and a standard deviation of 10. A higher score indicates higher levels of anxiety.

  10. Pre-/post-intervention changes in depressive symptoms [ Time Frame: 6 and 12 weeks ]
    The pre/post-changes in depressive symptoms, measured with a validated survey (PROMIS Depression CAT), will be compared between groups. The PROMIS Depression CAT is a computer adaptive test that measures anxiety related symptoms. For CATs, the number of items varies between 4 and 12. The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. The CAT will continue until either the standard error drops below a specified level or the participant has answered the maximum number of questions (12), whichever occurs first. The end result is a T-score in which the individual's responses are compared to the U.S. general population, which based on calibration testing has a mean of 50 and a standard deviation of 10. A higher score indicates higher levels of depression.

  11. Pre-/post-intervention changes in fatigue [ Time Frame: 6 and 12 weeks ]
    The pre/post-changes in fatigue, measured with a validated survey (PROMIS Fatigue CAT), will be compared between groups. The PROMIS Fatigue CAT is a computer adaptive test that measures anxiety related symptoms. For CATs, the number of items varies between 4 and 12. The response to the first item will guide the system's choice of the next item for the participant. The participant's response to the second item will dictate the selection of the following question, and so on. The CAT will continue until either the standard error drops below a specified level or the participant has answered the maximum number of questions (12), whichever occurs first. The end result is a T-score in which the individual's responses are compared to the U.S. general population, which based on calibration testing has a mean of 50 and a standard deviation of 10. A higher score indicates higher levels of fatigue.

  12. Pre-/post-intervention changes in sleep quality [ Time Frame: 6 weeks ]
    The pre/post-changes in sleep quality, measured with a validated survey (Insomnia Severity Index), will be compared between groups. The Insomnia Severity Index is a 7-item scale with a total score ranging between 0 and 28 that is used to assess the level of subjective sleep difficulties and insomnia-related symptoms over the past 2 weeks. A higher score indicates reduced sleep quality and more insomnia-related symptoms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy male and female CCF nurses
  • Abbreviated perceived stress scale (PSS-4) ≥ 7
  • English speaking
  • No history of major chronic medical conditions and/or diseases
  • Able to provide informed consent and comply with study protocol

Exclusion Criteria:

  • Significant chronic medical condition and/or disease
  • Smoking
  • Pregnancy
  • Current use of antidepressants or any other psychiatric medication
  • Current diagnosis of anxiety and/or depression
  • History of any psychiatric diagnosis other than anxiety or depression
  • Estrogen or hormone replacement therapy use
  • Diagnosis of post-traumatic stress disorder
  • Current use of any immunosuppressive medication
  • No current or past meditation practice

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): NCT03753360


Contacts
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Contact: Brett Graham 216-444-2200 grahamb2@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Brett Graham    216-444-2200    grahamb2@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic

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Responsible Party: Leonard Calabrese, Director of the RJ Fasenmyer Center for Clinical Immunology, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03753360     History of Changes
Other Study ID Numbers: 18-681
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

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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 Leonard Calabrese, The Cleveland Clinic:
Stress
Mindfulness
Meditation
Gene expression
Immune
Online
Healthcare workers
Burnout
Cytokines
Cortisol

Additional relevant MeSH terms:
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Burnout, Psychological
Stress, Psychological
Burnout, Professional
Behavioral Symptoms
Occupational Stress
Occupational Diseases