Stress, Psychological Clinical Trial
Official title:
Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial
Verified date | April 2021 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Stress among healthcare professionals is well documented. Untreated stress can lead to anxiety, depression, substance use, and suicide. The use of mindfulness-based programs to reduce stress and enhance wellbeing, among health care professionals, has increased with promising results. Typical mindfulness-based programs are 30 hours in length across 9 sessions. The purpose of this study is to assess the effectiveness of a shorter and more practical program that could be offered during work hours to health care professionals at the NIH Clinical Center. The program will be delivered in five weekly 1.5 hour sessions.
Status | Completed |
Enrollment | 82 |
Est. completion date | June 15, 2018 |
Est. primary completion date | June 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Any National Institutes of Health (NIH) employee, contractor, or trainee willing and able to participate in a 5-week mindfulness-based self-care course during the work day. - English speaking Exclusion Criteria - Persons with medical and psychiatric conditions were advised to consult with their health care practitioners prior to enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
Ameli, R. (2013). 25 Lessons in Mindfulness : Now Time for Healthy Living (First edition. ed.). Washington, D.C.: American Psychological Association.
de Vibe M, Solhaug I, Rosenvinge JH, Tyssen R, Hanley A, Garland E. Six-year positive effects of a mindfulness-based intervention on mindfulness, coping and well-being in medical and psychology students; Results from a randomized controlled trial. PLoS One. 2018 Apr 24;13(4):e0196053. doi: 10.1371/journal.pone.0196053. eCollection 2018. — View Citation
Dyrbye LN, Shanafelt TD. Physician burnout: a potential threat to successful health care reform. JAMA. 2011 May 18;305(19):2009-10. doi: 10.1001/jama.2011.652. — View Citation
Krasner MS, Epstein RM, Beckman H, Suchman AL, Chapman B, Mooney CJ, Quill TE. Association of an educational program in mindful communication with burnout, empathy, and attitudes among primary care physicians. JAMA. 2009 Sep 23;302(12):1284-93. doi: 10.1001/jama.2009.1384. — View Citation
West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28. Review. — View Citation
West CP, Dyrbye LN, Rabatin JT, Call TG, Davidson JH, Multari A, Romanski SA, Hellyer JM, Sloan JA, Shanafelt TD. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):527-33. doi: 10.1001/jamainternmed.2013.14387. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceived Stress Scale (PSS) | The Perceived Stress Scale (PSS) is used to assess self-reported perceived stress. It is a 10-item scale, with a total range from 0 (no symptoms) to 40 (highest severity). | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) | |
Secondary | Mindful Attention Awareness Scale (MAAS) - Trait Version | The Mindful Attention Awareness Scale-Trait Version (MAAS-T) is used to assess self-reported trait mindfulness. It is a 15-item scale, with a total range from 0 (low mindfulness) to 90 (high mindfulness). | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) | |
Secondary | Mindful Attention Awareness Scale (MAAS) - State Version | The Mindful Attention Awareness Scale-State Version (MAAS-S) is used to assess self-reported state mindfulness. It is a 5-item scale, with a total range from 0 (high mindfulness) to 30 (low mindfulness). | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) | |
Secondary | Positive Affect Scores (PANAS) | The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect).
These are the Positive Affect Scores |
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) | |
Secondary | Visual Analog Scale-Anxiety (VAS-A) | Visual Analog Scale-Anxiety (VAS-A) is used to assess self-reported anxiety. It is a 1-item scale, with a total range from 1 (low anxiety) to 10 (high anxiety). | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) | |
Secondary | Mindful Self Care Scale-General (MSCS-G) | Mindful Self Care Scale-General (MSCS-G) is used to assess self-reported mindful self care. It is a 3-item scale, with a total range from 0 (low self care) to 12 (high self care). | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) | |
Secondary | Maslach Burnout Inventory (MBI) | The Maslach Burnout Inventory (MBI 2-Item) is used to assess self-reported burnout. The 2-Item inventory assesses emotional exhaustion (Item-1) and depersonalization (Item-2) separately from 1 (no symptoms) to 7 (highest severity). | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) | |
Secondary | Negative Affect Scores (PANAS) | The Positive And Negative Affect Scale (PANAS) is used to assess self-reported positive and negative affect. It is a two dimension scale, with total ranges for each scale from 0 (low positive/negative affect) to 50 (high positive/negative affect).
These are the Negative Affect Scores |
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
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