Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals

• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT03781336
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.4
• Patients Per Site Per Month: 9.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress, Professional; Stress, Psychological	Behavioral: Mindfulness-based self care	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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)
• Primary Purpose: Supportive Care
• Official Title: Brief Mindfulness Meditation Course to Reduce Stress in Healthcare Professionals and Trainees: A Randomized Clinical Trial
• Actual Study Start Date: Oct 1, 2017
• Actual Primary Completion Date: Jun 15, 2018
• Actual Study Completion Date: Jun 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness-based self-care Mindfulness-based self-care (5 weeks)	Behavioral: 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.
No Intervention: Life as usual control Life as usual control (5 weeks)

Outcome Measures

Primary Outcome Measures

1. Perceived Stress Scale (PSS) [Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)]

   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).

Secondary Outcome Measures

1. Mindful Attention Awareness Scale (MAAS) - Trait Version [Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)]

   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).

2. Mindful Attention Awareness Scale (MAAS) - State Version [Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)]

   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).

3. Positive Affect Scores (PANAS) [Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)]

   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

4. Visual Analog Scale-Anxiety (VAS-A) [Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)]

   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).

5. Mindful Self Care Scale-General (MSCS-G) [Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)]

   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).

6. Maslach Burnout Inventory (MBI) [Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)]

   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).

7. Negative Affect Scores (PANAS) [Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Institutes of Health Clinical Center (CC)

Investigators

• Principal Investigator: Rezvan Ameli, PhD, National Institutes of Health Clinical Center (CC)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 23, 2017

More Information

Publications

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

• Responsible Party: Rezvan Ameli, Principal Investigator, National Institutes of Health Clinical Center (CC)
• ClinicalTrials.gov Identifier: NCT03781336
• Other Study ID Numbers: 17-MH-0018
• First Posted: Dec 19, 2018
• Last Update Posted: May 12, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rezvan Ameli, Principal Investigator, National Institutes of Health Clinical Center (CC): mindfulness; stress; resilience building; meditation; healthcare professionals; trainees; physicians; nurses
• Additional relevant MeSH terms: Occupational Stress; Stress, Psychological

Study Results

Participant Flow

Arm/Group Title	Mindfulness-based Self-care	Life as Usual Control
Arm/Group Description	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.	Life as usual control (5 weeks)
Period Title: Overall Study
STARTED	45	37
COMPLETED	43	35
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Mindfulness-based Self-care	Life as Usual Control	Total
Arm/Group Description	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.	Life as usual control (5 weeks)	Total of all reporting groups
Overall Participants	43	35	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.7 (15.4)	36.4 (13.0)	36.0 (14.3)
Sex: Female, Male (Count of Participants)
Female	37 86%	28 80%	65 83.3%
Male	6 14%	7 20%	13 16.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 11.6%	5 14.3%	10 12.8%
Not Hispanic or Latino	38 88.4%	30 85.7%	68 87.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.3%	0 0%	1 1.3%
Asian	7 16.3%	6 17.1%	13 16.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 7%	2 5.7%	5 6.4%
White	27 62.8%	21 60%	48 61.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	5 11.6%	6 17.1%	11 14.1%
Marital status (Count of Participants)
Single	28 65.1%	19 54.3%	47 60.3%
Married	8 18.6%	12 34.3%	20 25.6%
Divorced or separated	3 7%	3 8.6%	6 7.7%
Widowed or other	4 9.3%	1 2.9%	5 6.4%
Religion (Count of Participants)
Agnostic	1 2.3%	2 5.7%	3 3.8%
Atheism	5 11.6%	3 8.6%	8 10.3%
Buddhism	2 4.7%	2 5.7%	4 5.1%
Christianity	18 41.9%	13 37.1%	31 39.7%
Hinduism	3 7%	2 5.7%	5 6.4%
Islam	2 4.7%	3 8.6%	5 6.4%
Judaism	2 4.7%	2 5.7%	4 5.1%
Not affiliated or other	10 23.3%	8 22.9%	18 23.1%
Current position (Count of Participants)
Administrator	7 16.3%	3 8.6%	10 12.8%
Nurse	2 4.7%	3 8.6%	5 6.4%
PhD Scientist	6 14%	3 8.6%	9 11.5%
Physician	7 16.3%	11 31.4%	18 23.1%
Social Worker	2 4.7%	3 8.6%	5 6.4%
Training Fellow	19 44.2%	12 34.3%	31 39.7%
Education level (Count of Participants)
Some college	1 2.3%	1 2.9%	2 2.6%
Completed college	22 51.2%	14 40%	36 46.2%
Graduate school or Advance degree	20 46.5%	20 57.1%	40 51.3%
Preexisting condition (participants) [Number]
Medical condition	16 37.2%	9 25.7%	25 32.1%
Psychiatric condition	16 37.2%	14 40%	30 38.5%

Outcome Measures

1. Primary Outcome

Title	Perceived Stress Scale (PSS)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Self-care	Life as Usual Control
Arm/Group Description	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.	Life as usual control (5 weeks)
Measure Participants	43	35
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)

2. Secondary Outcome

Title	Mindful Attention Awareness Scale (MAAS) - Trait Version
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Self-care	Life as Usual Control
Arm/Group Description	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.	Life as usual control (5 weeks)
Measure Participants	43	35
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)

3. Secondary Outcome

Title	Mindful Attention Awareness Scale (MAAS) - State Version
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Self-care	Life as Usual Control
Arm/Group Description	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.	Life as usual control (5 weeks)
Measure Participants	43	35
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)

4. Secondary Outcome

Title	Positive Affect Scores (PANAS)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Self-care	Life as Usual Control
Arm/Group Description	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.	Life as usual control (5 weeks)
Measure Participants	43	35
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)

5. Secondary Outcome

Title	Visual Analog Scale-Anxiety (VAS-A)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Self-care	Life as Usual Control
Arm/Group Description	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.	Life as usual control (5 weeks)
Measure Participants	43	35
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)

6. Secondary Outcome

Title	Mindful Self Care Scale-General (MSCS-G)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Self-care	Life as Usual Control
Arm/Group Description	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.	Life as usual control (5 weeks)
Measure Participants	43	35
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)

7. Secondary Outcome

Title	Maslach Burnout Inventory (MBI)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Self-care	Life as Usual Control
Arm/Group Description	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.	Life as usual control (5 weeks)
Measure Participants	43	35
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)

8. Secondary Outcome

Title	Negative Affect Scores (PANAS)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness-based Self-care	Life as Usual Control
Arm/Group Description	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.	Life as usual control (5 weeks)
Measure Participants	43	35
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

Time Frame	Week-5 (post-intervention)
Adverse Event Reporting Description	Adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov.
Arm/Group Title	Mindfulness-based Self-care		Life as Usual Control
Arm/Group Description	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.		Life as usual control (5 weeks)
All Cause Mortality
	Mindfulness-based Self-care		Life as Usual Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/35 (0%)
Serious Adverse Events
	Mindfulness-based Self-care		Life as Usual Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Mindfulness-based Self-care		Life as Usual Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.