Clinical trial NCT03781336: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Professional
Stress, Psychological
Keywords: mindfulness
stress
resilience building
meditation
healthcare professionals
trainees
physicians
nurses
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2018-12-19
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Secondary outcomes:
measure: Mindful Attention Awareness Scale (MAAS) - Trait Version
timeFrame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
measure: Mindful Attention Awareness Scale (MAAS) - State Version
timeFrame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
measure: Positive Affect Scores (PANAS)
timeFrame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
measure: Visual Analog Scale-Anxiety (VAS-A)
timeFrame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
measure: Mindful Self Care Scale-General (MSCS-G)
timeFrame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
measure: Maslach Burnout Inventory (MBI)
timeFrame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
measure: Negative Affect Scores (PANAS)
timeFrame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Rezvan Ameli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ameli, R. (2013). 25 Lessons in Mindfulness : Now Time for Healthy Living (First edition. ed.). Washington, D.C.: American Psychological Association.
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.
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.
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.
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.
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.
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.
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.