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Stress, ProfessionalNCT03781336

Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals

A study testing Mindfulness-based self care in people with Stress, Professional and Stress, Psychological, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stress, Professional, Stress, Psychological
What is being tested?
Mindfulness-based self care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
1 Oct 2017to 15 Jun 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Persons with medical and psychiatric conditions were advised to consult with their health care practitioners prior to enrollment.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institutes of Health

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial

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.

Read the 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.
Being tested
Mindfulness-based self care
Keywords
mindfulness, stress, resilience building, meditation, healthcare professionals, trainees, physicians, nurses
Medical subject headings
Occupational Stress, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-based self careBehavioural

    Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.

Study groups in NCT03781336
Study groupRoleWhat they receive
Mindfulness-based self-careExperimentalMindfulness-based self-care (5 weeks)
Receives: Behavioral: Mindfulness-based self care
Life as usual controlNo interventionLife as usual control (5 weeks)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

Secondary outcomes (7)
  1. 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).

    Measured: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

  2. 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).

    Measured: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

  3. 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

    Measured: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

  4. 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).

    Measured: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

  5. 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).

    Measured: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

  6. 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).

    Measured: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

  7. 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

    Measured: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start1 Oct 2017
  3. Primary completion15 Jun 2018
  4. Study completion15 Jun 2018

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03781336
Sponsor's protocol ID
17-MH-0018
Status last verified
Apr 2021
First submitted
18 Dec 2018
Last updated
12 May 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ameli, R. (2013). 25 Lessons in Mindfulness : Now Time for Healthy Living (First edition. ed.). Washington, D.C.: American Psychological Association.

  • 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.

    PubMed 19773563
  • 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.

    PubMed 29689081
  • 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.

    PubMed 27692469
  • 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.

    PubMed 21586718
  • 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.

    PubMed 24515493
  • 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.

    PubMed 32840621
  • 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.

    PubMed 32627860

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-based self care in people with Stress, Professional and Stress, Psychological, run by National Institutes of Health Clinical Center (CC) 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 2 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 12 May 2021. 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?

Yes. Results are posted in the registry (first posted 15 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Perceived Stress Scale (PSS) (time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03781336, which also lists 8 linked publications.

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 12 May 2021.

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