Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based self-care | Experimental | Mindfulness-based self-care (5 weeks) |
|
| Life as usual control | No Intervention | Life as usual control (5 weeks) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based self care | Behavioral | Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
Not provided
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rezvan Ameli, PhD | National Institutes of Health Clinical Center (CC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ameli, R. (2013). 25 Lessons in Mindfulness : Now Time for Healthy Living (First edition. ed.). Washington, D.C.: American Psychological Association. | ||
| 19773563 | 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. | |
| 29689081 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-based Self-care | Mindfulness-based self-care (5 weeks) Mindfulness-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. |
| FG001 | Life as Usual Control | Life as usual control (5 weeks) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-based Self-care | Mindfulness-based self-care (5 weeks) Mindfulness-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. |
| BG001 | Life as Usual Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
|
Week-5 (post-intervention)
Adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-based Self-care | Mindfulness-based self-care (5 weeks) Mindfulness-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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Psychologist | National Institutes of Health | 3014027360 | amelir@mail.nih.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2017 | Sep 11, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000073397 | Occupational Stress |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D009784 | Occupational Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 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). |
| 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 | 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). | 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). | 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). | 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 | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
| Background |
| 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. |
| 27692469 | Background | 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. |
| 21586718 | Background | 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. |
| 24515493 | Background | 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. |
| 32840621 | Derived | 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. |
| 32627860 | Derived | 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. |
Life as usual control (5 weeks) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Religion | Count of Participants | Participants |
|
| Current position | Count of Participants | Participants |
|
| Education level | Count of Participants | Participants |
|
| Preexisting condition | Number | participants |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up) |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Life as Usual Control | Life as usual control (5 weeks) | 0 | 35 | 0 | 35 | 0 | 35 |
Not provided
Not provided
Not provided
| Follow-up |
|
| Follow-up |
|
| Follow-up |
|
| Follow-up |
|
| Follow-up |
|
| Follow-up-item 1 |
|
| Baseline-item 2 |
|
| Postintervention-item 2 |
|
| Follow-up-item 2 |
|
| Follow-up |
|