NCT03781336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 15, 2021

Completed
Last Updated

May 12, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

December 18, 2018

Results QC Date

February 19, 2021

Last Update Submit

April 14, 2021

Conditions

Stress, ProfessionalStress, Psychological

Keywords

mindfulnessstressresilience buildingmeditationhealthcare professionalstraineesphysiciansnurses

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (7)

  • Mindful Attention Awareness Scale (MAAS) - Trait Version

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

  • Mindful Attention Awareness Scale (MAAS) - State Version

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

  • Positive Affect Scores (PANAS)

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

  • Visual Analog Scale-Anxiety (VAS-A)

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

  • Mindful Self Care Scale-General (MSCS-G)

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

  • +2 more secondary outcomes

Study Arms (2)

Mindfulness-based self-care

EXPERIMENTAL

Mindfulness-based self-care (5 weeks)

Behavioral: Mindfulness-based self care

Life as usual control

NO INTERVENTION

Life as usual control (5 weeks)

Interventions

Mindfulness-based self careBEHAVIORAL

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

Mindfulness-based self-care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health

Bethesda, Maryland, 20892, United States

Location

Related Publications (8)

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

    BACKGROUND

  • 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.

    PMID: 19773563BACKGROUND

  • 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.

    PMID: 29689081BACKGROUND

  • 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.

    PMID: 27692469BACKGROUND

  • 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.

    PMID: 21586718BACKGROUND

  • 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.

    PMID: 24515493BACKGROUND

  • 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.

    PMID: 32840621DERIVED

  • 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.

    PMID: 32627860DERIVED

MeSH Terms

Conditions

Occupational StressStress, Psychological

Condition Hierarchy (Ancestors)

Occupational DiseasesBehavioral SymptomsBehavior

Results Point of Contact

Title
Psychologist
Organization
National Institutes of Health
amelir@mail.nih.gov
3014027360

Study Officials

  • Rezvan Ameli, PhD

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2018

First Posted

December 19, 2018

Study Start

October 1, 2017

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

May 12, 2021

Results First Posted

April 15, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)