Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals
Primary Purpose
Stress, Professional, Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based self care
Sponsored by
About this trial
This is an interventional supportive care trial for Stress, Professional focused on measuring mindfulness, stress, resilience building, meditation, healthcare professionals, trainees, physicians, nurses
Eligibility Criteria
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.
Sites / Locations
- National Institutes of Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness-based self-care
Life as usual control
Arm Description
Mindfulness-based self-care (5 weeks)
Life as usual control (5 weeks)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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
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).
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).
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).
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
Full Information
NCT ID
NCT03781336
First Posted
December 18, 2018
Last Updated
April 14, 2021
Sponsor
National Institutes of Health Clinical Center (CC)
1. Study Identification
Unique Protocol Identification Number
NCT03781336
Brief Title
Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals
Official Title
Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institutes of Health Clinical Center (CC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
This abridged program was designed by Dr. Rezvan Ameli who is an expert in mindfulness-based practices/therapies and was in response to the expressed needs of the NIH clinical staff and the NIH fellowship training program.
Participants completed all primary and secondary outcome measure questionnaires at week -1, 5 and 13. The life as usual control group completed all primary and secondary outcome measures at week -1, and 5.
The program is described below:
The program consisted of 5 sessions. A class binder was prepared for the participants and included information about mindfulness and its practice, practices covered in each session, Practice Plan work sheets to design home practices, pertinent reference list, guide to online services, programs and apps, selected poetry, and information regarding recorded instructions for body scan and mindful breathing by the instructor which was made available on the institution's website and could be downloaded by the participants. Each session was 1.5 hours in length and was offered on Fridays from 3-4:30 pm. Classes were instructed by Rezvan Ameli, Ph.D., clinical psychologist, an experienced mindfulness practitioner since 2003 and teacher since 2008. In addition to her background as a licensed clinical psychologist, mindfulness practitioner, teacher and writer (Ameli 2013), RA is a certified yoga teacher and is registered with the Yoga Alliance (RYT-200).
Common Elements of the Sessions
The first 4 classes began with 20-25 minutes of mindful movement/ light yoga (TNH sounds true, ITP kata). We did not include movements in the 5th (last) session due to time constraints. The emphasis during mindful movements was on the coordination of movement and the breath with the instruction that when the mind wandered away to gently bring it back and refocus on the breath and movements. Participants were encouraged to only engage in movements that felt comfortable but not straining, painful, or felt unsafe. Each class had a period of "check in". During the first check in, participants shared their names, a brief statement about the reason for their participation, and their current self-care practice/s if any. Class guidelines including confidentiality were reviewed at this time. In subsequent check-ins the participants addressed their questions regarding mindfulness practices and class teachings, described their practice with a focus on self-care, their existing self-care practices and new learnings from the class, and any obstacles to their practice and to their self-care during the preceding week. Other common elements of the sessions included a period of inquiry, i.e. question and answer, after each new practice was introduced, planning a week of practice based on class learnings, post class ratings, and concluding the class with a relevant poem. Home practice planning was done in dyads of participants who were then encouraged to stay in touch, become a "buddy" to their class partner, and communicate during the week about their practice. Every session included a period of mindful breathing. The length of mindful breathing (sitting meditation) was gradually increased from 10 minutes in the 1st session to 30 minutes in the 5th session.
Session Specific Practices
In addition to these common elements, each session included a theme and other specific mindfulness practices as follows:
Session 1- Theme: Introduction to mindfulness. This session included definition of mindfulness and its foundations (Kabat-Zin, 1992), mindful breathing and body scan.
Session 2- Theme: Enhancing Awareness & Focused Attention. This session included mindfulness of sounds, a short body scan, mindful breathing, and mindful eating, i.e. the "raisin exercise" (ref). In addition, a discussion of mindful consumption and its relevance to self-care was explored (Ameli 2013).
Session 3 -Theme: Awareness of pleasurable experiences. This session included mindfulness of the breath (briefly incorporating sounds, body sensation, thoughts, feelings and then focusing on the breath), and mindful walking. The importance of awareness of pleasurable experiences were discussed and an exercise to enhance attention to pleasurable experiences was performed in dyads (Ameli 2013).
Session 4- Theme: Transformation of difficult emotions through mindfulness. In this session the concept of transforming difficult emotions through the practice of mindfulness was discussed, explored, and practiced. The acronym RAIN (recognize, accept/allow, investigate, and non-identification) was utilized to facilitate this practice.
Session 5- Theme: Compassion. This session mindful breathing and a general discussion of compassion, compassion towards self and other, and the practice of loving kindness (Ameli 2013). The class was concluded with a "check-out" where participants briefly shared their overall experiences and learnings and their goals/vision for future self-care activities and practices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Professional, Stress, Psychological
Keywords
mindfulness, stress, resilience building, meditation, healthcare professionals, trainees, physicians, nurses
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are allocated into the mindfulness-based self-care group or a wait list group for 5 weeks. Since the group is offered during work hours, the waitlist group could be best described as "life as usual". After group allocation, all participants completed demographic and self report clinical assessments at baseline, and self report clinical assessments at follow-up.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based self-care
Arm Type
Experimental
Arm Description
Mindfulness-based self-care (5 weeks)
Arm Title
Life as usual control
Arm Type
No Intervention
Arm Description
Life as usual control (5 weeks)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based self care
Intervention Description
Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
Primary Outcome Measure Information:
Title
Perceived Stress Scale (PSS)
Description
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).
Time Frame
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Secondary Outcome Measure Information:
Title
Mindful Attention Awareness Scale (MAAS) - Trait Version
Description
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).
Time Frame
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Title
Mindful Attention Awareness Scale (MAAS) - State Version
Description
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).
Time Frame
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Title
Positive Affect Scores (PANAS)
Description
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
Time Frame
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Title
Visual Analog Scale-Anxiety (VAS-A)
Description
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).
Time Frame
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Title
Mindful Self Care Scale-General (MSCS-G)
Description
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).
Time Frame
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Title
Maslach Burnout Inventory (MBI)
Description
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).
Time Frame
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Title
Negative Affect Scores (PANAS)
Description
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
Time Frame
Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rezvan Ameli, PhD
Organizational Affiliation
National Institutes of Health Clinical Center (CC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Ameli, R. (2013). 25 Lessons in Mindfulness : Now Time for Healthy Living (First edition. ed.). Washington, D.C.: American Psychological Association.
Results Reference
background
PubMed Identifier
19773563
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.
Results Reference
background
PubMed Identifier
29689081
Citation
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.
Results Reference
background
PubMed Identifier
27692469
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.
Results Reference
background
PubMed Identifier
21586718
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. No abstract available.
Results Reference
background
PubMed Identifier
24515493
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.
Results Reference
background
PubMed Identifier
32840621
Citation
Ameli R, Sinaii N, West CP, Luna MJ, Panahi S, Zoosman M, Rusch HL, Berger A. Effect of a Brief Mindfulness-Based Program on Stress in Health Care Professionals at a US Biomedical Research Hospital: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2013424. doi: 10.1001/jamanetworkopen.2020.13424.
Results Reference
derived
PubMed Identifier
32627860
Citation
Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
Results Reference
derived
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Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals
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