CompletedNCT03781336Updated May 12, 2021Results posted

Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals

An interventional study of Mindfulness-based self care in Stress, Professional and Stress, Psychological, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-12.

Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Supportive care

From the registry’s dates

Registered 1 year 2 months after the study started (first participant enrolled Oct 2017, registered Dec 2018).

Phase: Not applicable
Study type: Interventional
Enrollment: 82
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

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.

Conditions studied

Stress, Professional
Stress, Psychological

Browse trials for

Keywords

mindfulness
stress
resilience building
meditation
healthcare professionals
trainees
physicians
nurses

In context

Occupational Stress

236 studies on the registry are indexed under Occupational Stress; 64 are open to participants now.

This study's enrollment of 82 is close to the median of 89 across 167 interventional studies indexed under Occupational Stress.

Browse Occupational Stress studies →

Lead sponsor

National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Exclusion Criteria

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

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 82 participants (actual)

Study arms

Experimental
Mindfulness-based self-care
Mindfulness-based self-care (5 weeks)
Behavioral: Mindfulness-based self care
No intervention
Life as usual control
Life as usual control (5 weeks)

Interventions

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

What researchers measure

Primary outcomes

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).
Time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

Secondary outcomes

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).
Time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
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).
Time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
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
Time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
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).
Time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
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).
Time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
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).
Time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
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
Time frame: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)

Results

Posted Apr 15, 2021

Participant flow

Participant flow — Overall Study
Milestone	Mindfulness-based Self-care	Life as Usual Control
Started	45	37
Completed	43	35
Not completed	2	2
Withdrew: Withdrawal by subject	2	2

Outcome measures

PrimaryPerceived 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).

Time frame:: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Reported as:: Mean · score on a scale

Perceived Stress Scale (PSS)
score on a scale	Mindfulness-based Self-care	Life as Usual Control
Baseline	19.63 ± 6.26	18.80 ± 6.36
Postintervention	17.29 ± 5.84	18.54 ± 6.30
Follow-up	13.80 ± 6.45	NA ± NA

SecondaryMindful 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).

Time frame:: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Reported as:: Mean · score on a scale

Mindful Attention Awareness Scale (MAAS) - Trait Version
score on a scale	Mindfulness-based Self-care	Life as Usual Control
Baseline	3.74 ± 0.99	3.61 ± 0.89
Postintervention	3.95 ± 0.83	3.70 ± 0.96
Follow-up	4.33 ± 0.85	NA ± NA

SecondaryMindful 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).

Time frame:: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Reported as:: Mean · score on a scale

Mindful Attention Awareness Scale (MAAS) - State Version
score on a scale	Mindfulness-based Self-care	Life as Usual Control
Baseline	2.23 ± 1.24	2.48 ± 1.08
Postintervention	3.74 ± 1.18	2.78 ± 1.16
Follow-up	4.08 ± 1.04	NA ± NA

SecondaryPositive 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

Time frame:: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Reported as:: Mean · units on a scale

Positive Affect Scores (PANAS)
units on a scale	Mindfulness-based Self-care	Life as Usual Control
Baseline	32.85 ± 7.73	33.67 ± 5.95
Postintervention	35.69 ± 7.12	31.42 ± 7.27
Follow-up	36.13 ± 8.43	NA ± NA

SecondaryVisual 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).

Time frame:: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Reported as:: Mean · score on a scale

Visual Analog Scale-Anxiety (VAS-A)
score on a scale	Mindfulness-based Self-care	Life as Usual Control
Baseline	4.72 ± 1.62	4.57 ± 1.69
Postintervention	2.58 ± 1.52	4.23 ± 1.73
Follow-up	3.29 ± 1.47	NA ± NA

SecondaryMindful 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).

Time frame:: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Reported as:: Mean · score on a scale

Mindful Self Care Scale-General (MSCS-G)
score on a scale	Mindfulness-based Self-care	Life as Usual Control
Baseline	5.60 ± 2.75	6.00 ± 2.88
Postintervention	7.29 ± 2.44	5.54 ± 2.77
Follow-up	6.37 ± 2.76	NA ± NA

SecondaryMaslach 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).

Time frame:: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Reported as:: Mean · score on a scale

Maslach Burnout Inventory (MBI)
score on a scale	Mindfulness-based Self-care	Life as Usual Control
Baseline-item 1	2.95 ± 1.56	3.29 ± 1.45
Postintervention-item 1	2.89 ± 1.63	2.74 ± 1.62
Follow-up-item 1	2.31 ± 1.64	NA ± NA
Baseline-item 2	1.76 ± 1.32	1.6 ± 1.42
Postintervention-item 2	1.22 ± 1.13	1.57 ± 1.36
Follow-up-item 2	1.34 ± 1.21	NA ± NA

SecondaryNegative Affect Scores (PANAS)

Time frame:: Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)
Reported as:: Mean · units on a scale

Negative Affect Scores (PANAS)
units on a scale	Mindfulness-based Self-care	Life as Usual Control
Baseline	21.44 ± 7.38	21.21 ± 7.27
Postintervention	20.73 ± 6.24	19.09 ± 7.60
Follow-up	18.22 ± 6.01	NA ± NA

Adverse events

Collected over Week-5 (post-intervention). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Mindfulness-based Self-care	0/43 (0%)	0/43 (0%)	0/43 (0%)
Life as Usual Control	0/35 (0%)	0/35 (0%)	0/35 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Mindfulness-based Self-care	Life as Usual Control	Total
Mean	35.7 ± 15.4	36.4 ± 13.0	36.0 ± 14.3

Sex: Female, Male
Sex: Female, Male(Participants)	Mindfulness-based Self-care	Life as Usual Control	Total
Female	37	28	65
Male	6	7	13

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Mindfulness-based Self-care	Life as Usual Control	Total
Hispanic or Latino	5	5	10
Not Hispanic or Latino	38	30	68
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Mindfulness-based Self-care	Life as Usual Control	Total
American Indian or Alaska Native	1	0	1
Asian	7	6	13
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	3	2	5
White	27	21	48
More than one race	0	0	0
Unknown or Not Reported	5	6	11

Marital status
Marital status(Participants)	Mindfulness-based Self-care	Life as Usual Control	Total
Single	28	19	47
Married	8	12	20
Divorced or separated	3	3	6
Widowed or other	4	1	5

Religion
Religion(Participants)	Mindfulness-based Self-care	Life as Usual Control	Total
Agnostic	1	2	3
Atheism	5	3	8
Buddhism	2	2	4
Christianity	18	13	31
Hinduism	3	2	5
Islam	2	3	5
Judaism	2	2	4
Not affiliated or other	10	8	18

Current position
Current position(Participants)	Mindfulness-based Self-care	Life as Usual Control	Total
Administrator	7	3	10
Nurse	2	3	5
PhD Scientist	6	3	9
Physician	7	11	18
Social Worker	2	3	5
Training Fellow	19	12	31

Education level
Education level(Participants)	Mindfulness-based Self-care	Life as Usual Control	Total
Some college	1	1	2
Completed college	22	14	36
Graduate school or Advance degree	20	20	40

1 further baseline measures are reported on the registry.

Study locations

1 site

National Institutes of Health
Bethesda, Maryland 20892, United States

References and documents

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 ↗

Study documents

Protocol and statistical analysis plan · May 23, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03781336
Lead sponsor: National Institutes of Health Clinical Center (CC)
Responsible party: Rezvan Ameli (Principal Investigator, National Institutes of Health Clinical Center (CC)) — Principal investigator
First posted: Dec 19, 2018
Start date: Oct 1, 2017
Primary completion: Jun 15, 2018
Completion: Jun 15, 2018
Results posted: Apr 15, 2021
Last update: May 12, 2021

Study contacts

Rezvan Ameli, PhD

principal investigator · National Institutes of Health Clinical Center (CC)

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Occupational Stress→

Other studies from this sponsor

National Institutes of Health Clinical Center (CC)

Start the discussion