Nearly 50% of the adult workforce experience adverse psychological symptoms (e.g., stress, depression, burnout, etc.) stemming from workplace stressors, with healthcare workers experiencing rates as high as 80%. Some common complaints and downstream consequences of working in high-stress healthcare occupations are elevated levels of perceived stress, depression, and burnout. These conditions have been associated with unfavorable occupational (e.g., increased medical errors), patient (e.g., increased mortality rates), and provider-related outcomes (e.g., increased rates of cardiovascular disease), imposing a heavy burden on an already stretched system. Given the impact of perceived stress, depression, and burnout on employee and patient health, a clear need exists to develop effective interventions to reduce distress and promote well-being among healthcare professionals. In particular, interventions that target processes particularly vulnerable to provider stress (e.g., compassion) are needed. The present study will evaluate the feasibility and efficacy of a mindfulness-based intervention inspired by the Buddhist Four Immeasurables practice on reducing perceived stress (primary outcome), depressive symptoms, burnout, and biological markers of inflammation, and enhancing psychological well-being and sleep quality (secondary outcomes) in 80 healthcare workers. Additionally, we will investigate several mediators (compassion, positive emotions, equanimity, and mindfulness) of intervention effects. Participants will be healthcare employees of UCLA Health. They will be enrolled in a six-week, two-arm randomized controlled trial. Participants will complete self-report questionnaires at baseline, mid-course, and post-intervention to assess study outcomes and mediators. We aim to advance the study of interventions that reduce distress and promote well-being using practices that cultivate kind feelings toward oneself and others.
Healthcare providers face a large number of stressful situations daily, which may increase their risk of developing several adverse mental and physical health conditions. Some of the most common complaints and downstream consequences of working in high-stress healthcare occupations are elevated levels of perceptions of stress, depression, and burnout. Each of these conditions has been associated with a host of unfavorable occupational outcomes, including absenteeism, lost work productivity, increased medical errors, and poorer patient quality of care. Additionally, perceived stress, depression, and burnout have been associated with adverse provider outcomes, including increased rates of suicidality, substance misuse, exhaustion, musculoskeletal pain, and gastrointestinal complaints. Finally, these conditions impose a significant financial burden on an already strained healthcare system in the form of worker turnover and medical malpractice. Overview: This single-site, two-arm, parallel-group RCT is designed to evaluate the feasibility and efficacy of a meditation-based intervention (Building Emotional Strength Training \[BEST\]) for perceived stress relative to a waitlist control for full-time healthcare workers. The intervention will be delivered by an experienced mediation instructor, following a manualized protocol, in a live online group format once a week for six consecutive weeks, held on Zoom. Groups will be conducted during the workday at standardized times. Assessments will be conducted both before and after the intervention to evaluate the effects of the intervention on the outcome. Participants: Study participants will be 80 full-time healthcare workers employed by UCLA Health. They will be recruited in cohorts of 20-30 and randomized 1:1 to one of the two study arms. Participants will complete questionnaires and undergo blood collection on their own, which will be conducted before and after the six-week intervention. Additionally, several mechanisms of intervention effects will be assessed at the midpoint of the intervention (week three of the six-week intervention). Following CONSORT guidelines, we have designated one primary outcome for this trial: perceived stress. Additional (secondary) outcomes include symptoms of burnout, depression, subjective sleep quality, psychological well-being, and inflammatory processes, all of which have been associated with healthcare provider health and well-being and have been shown to be sensitive to the effects of meditation interventions. Further, several theory-based mechanisms of intervention effects include self-compassion, compassion for others, positive and negative emotions, equanimity, and mindfulness, all of which are plausible pathways through which meditation-based interventions may influence perceived stress. Eligibility Screening, Enrollment, and Baseline Assessment (T1). Potential participants will be directed to contact the study coordinator via email or phone. Research staff will then contact potential participants by phone to confirm eligibility criteria. The 4-item Perceived Stress Scale will be used to screen for at least moderate levels of stress. Those who score a "5" or above, indicating at least moderate levels of stress, will be considered eligible for study participation. Participants will be recruited in cohorts of 20-30 healthcare providers, who will be randomly assigned to either the BEST group or the waitlist control, allowing for our desired mindfulness group size of 10-15 participants. Screening will continue until we have an adequate number of eligible, interested, and available participants for the next cohort. All participants who are determined to be eligible will then review and verbally acknowledge the IRB-approved consent form. After obtaining consent and enrollment, participants will be emailed a link to complete the study questionnaires. The questionnaires will include the following: Background demographic and medical characteristics, health behaviors, Perceived Stress Scale (PSS), Maslach Burnout Inventor for Medical Personnel (MBI-M), Center for Epidemiological Studies-Depression (CES-D), Mental Health Continuum Short Form (MHC-SF), Insomnia Severity Index (ISI), Self-Compassion Scale (SCS), Compassion Scale (CS), modified Differential Emotions Scale (mDES), Equanimity Scale (ES), Five Factor Mindfulness Questionnaire (FFMQ). They will also receive an at-home blood collection kit in the mail to provide a blood sample for immune evaluation. Participants will provide blood samples for immune evaluation using the Tasso OnDemand device, which allows self-collection of a single capillary blood sample and does not require venipuncture. The Tasso device sticks to the skin with a light adhesive. When the button is pressed, a vacuum forms and a lancet pricks the surface of the skin. The vacuum draws blood out of the capillaries and into a sample pod attached to the bottom of the device. Participants will watch a demonstration video during their baseline assessment visit, and then use the device to collect a blood sample. Approximately 1/8th of a teaspoon of blood will be drawn at each in-person assessment. Participants will be advised to complete the blood collection in the morning to control for diurnal variations in immune parameters. Baseline assessments will be conducted during the 2 weeks preceding the onset of intervention. Study staff completing the eligibility screening, consent, and emailing participants the assessment links will be blind to participant group assignment. Randomization. Upon completion of the baseline assessment, participants will be randomized 1:1 to one of the two study conditions using the Qualtrics randomization feature by the study coordinator. The randomization feature on Qualtrics will be used to randomize participants. The study coordinator will inform participants of their assigned condition and provide them with information on the intervention (e.g., class dates and times, Zoom link, etc.). Interventions: The intervention will be delivered remotely via Zoom. Group sessions will be conducted during the workday (around lunchtime). Building Emotional Strength Training (BEST). The experimental mindfulness intervention was designed as a secularized version of the traditional Four Immeasurables practice. Diana Winston, Director of UCLA Mindful, developed the intervention based on her decades of experience working with new meditation practitioners and her expertise in designing group-based mindfulness courses for various audiences. In particular, she adapted a class previously offered through the Mindful Awareness Research Center (MARC) that focused on positive affect. Notably, the research team consulted with several healthcare professionals at UCLA to determine the most suitable delivery format, intervention duration, and optimal time of day for holding the intervention classes. The traditional Four Immeasurables practice includes exercises to promote the distinct emotional states of loving-kindness, compassion, sympathetic joy, and equanimity. The BEST curriculum is a six-week, group-based program where participants attend one class per week for six consecutive weeks. Each session focuses on a different component of the Four Immeasurables practice. During the one-hour class, participants will receive structured training and instruction in mindfulness exercises. The instructor will provide theoretical information and formal instructions on practicing the day's specific topic and will allow students to ask questions to enhance their learning. Additionally, participants will be guided through each meditation exercise introduced during class. Furthermore, each class will include dyadic discussions, allowing participants to interact directly with one another. The sessions will introduce the following topics and associated practices: 1) introduction to mindfulness, 2) further development of mindfulness, 3) loving-kindness, 4) compassion, 5) joy, and 6) equanimity. The BEST intervention also includes home practice, in which participants are encouraged to practice the meditation technique introduced in class that week at home, starting with five minutes and gradually increasing to 20 minutes per day throughout the six weeks of the intervention. Diana Winston will teach all classes. Waitlist Control (WLC). The WLC will control for naturally occurring changes in the outcomes and mediators over the assessment period. Participants in this group will not engage in any study-related activities outside of the remote assessments. Participants randomized to this condition will be offered the BEST intervention after all data collection is completed. Mid-Course Assessment (T2). At the halfway point of the intervention, all participants will be emailed a link to complete self-report questionnaires assessing the primary outcome and mediator variables only. Post-Intervention Assessment (T3). All participants will be emailed the post-intervention assessment link and mailed a second blood collection kit to complete both tasks within 2 weeks following the conclusion of the study intervention. The questionnaire will include all study variables.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
80
The BEST intervention was designed as a secularized version of the traditional Four Immeasurables practice to promote the distinct emotional states of loving-kindness, compassion, sympathetic joy, and equanimity. Each session provides structured training and exercises in mindfulness, including formal meditation practices and strategies for the daily informal use of mindfulness, as well as opportunity for questions and group discussion. Home practice is a key component of BEST and is particularly important for addressing stress in daily life. Participants will be instructed to practice mindfulness techniques on a daily basis, beginning with five minutes and increasing to 20 minutes, with practice prior to work or other stress-inducing situations.
University of California, Los Angeles
Los Angeles, California, United States
RECRUITINGMean Change from Baseline in Perceived Stress as Assessed by the Perceived Stress Scale
Stress will be assessed using the ten-item Perceived Stress Scale (PSS). The PSS evaluates how often individuals appraised situations in their lives as stressful during the past month (e.g., "In the last month, how often have you been angered because of things that were outside of your control?"). Respondents respond on a five-point Likert scale from 0 (never) to 4 (very often). All scores are summed to provide a total stress score. Scores range from 0 to 40, with higher scores indicating a higher level of perceived stress. The PSS has been widely used with healthcare professional populations and has been shown to be responsive to mindfulness-based interventions.
Time frame: At baseline, mid-course at week 3, and post-intervention at week 6.
Mean Change from Baseline in Depressive Symptoms as Assessed with the Center for Epidemiological Studies Depression Scale
Depressive symptoms will be based on scores on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), a commonly used depression measure. The CES-D is a reliable, validated, and widely used measure that includes central components of depressive symptomatology, including depressed mood, worthlessness, hopelessness, loss of appetite, and psychomotor retardation. Respondents respond to twenty statements that assess how often the individual felt or behaved during the past week (e.g., "I felt that I could not shake off the blues even with help from my family and friends") on a four-point Likert scale from 0 (rarely or none of the time \[less than 1 day\]) to 3 (most or all of the time \[5-7 days\]). All 20 items will be summed to provide a total score. The possible range of scores is 0-60, with higher scores indicating a greater frequency of depressive symptoms. The CES-D has frequently been used to assess depressive symptoms in healthcare workers.
Time frame: At baseline and post-intervention at week 6.
Mean Change from Baseline in Burnout as Assessed with the Maslach Burnout Inventory for Medical Personnel
Burnout will be measured via the 22-item Maslach Burnout Inventory for Medical Personnel (MBI-M). The MBI-M measures three components of burnout: emotional exhaustion, depersonalization, and reduced personal accomplishment. Emotional exhaustion refers to feeling emotionally overextended and exhausted by one's work. Depersonalization refers to an impersonal response toward the recipients of one's services. Personal accomplishment refers to feelings of competence and achievement in work-related pursuits. Items are scored on a 7-point Likert scale from 0 (never) to 6 (every day). Higher scores on the emotional exhaustion and depersonalization subscales correspond to a greater experience of burnout. The personal accomplishment subscale is positively worded; therefore, a one-item increase corresponds to a greater experience of work-related efficacy. Each subscale will be summed, providing a total score for emotional exhaustion, depersonalization, and personal accomplishment.
Time frame: At baseline and post-intervention at week 6.
Mean Change from Baseline in Psychological Well-being as Assessed with the Mental Health Continuum Short Form
Well-being will be measured using the 14-item Mental Health Continuum Short Form (MHC-SF). The MHC-SF is a 14-item scale that measures three dimensions of psychological well-being: hedonic, eudaimonic-social, and eudaimonic-psychological. Hedonic well-being refers to pleasurable states characterized by the presence of positive and absence of negative affect. Eudaimonic social well-being refers to flourishing within a social context characterized by social coherence and actualization. Eudaimonic psychological well-being refers to a sense of living a life of purpose, characterized by feelings of personal growth and self-actualization. Respondents respond to the fourteen items to assess how often they felt concerning the statements during the past month, using a six-point Likert scale ranging from 0 (never) to 5 (every day). All scores are summed to provide a total well-being score. The possible range of scores is 0-70, with higher scores indicating greater subjective well-being.
Time frame: At baseline and post-intervention at week 6.
Mean Change from Baseline in Sleep Quality as Assessed with the Insomnia Severity Index
Sleep quality will be assessed using the seven-item Insomnia Severity Index (ISI). The ISI is a reliable and valid self-report measure that evaluates the severity and impact of insomnia over the past two weeks. Respondents are asked to respond to the seven items to assess how they relate to each statement over the past two weeks, using a five-point Likert scale ranging from 0 (not at all) to 4 (very much). Scores are summed to obtain a total score. The possible range of scores on the ISI is 0-28, with higher scores indicating more severe insomnia. Additionally, scores of 15 or higher are indicative of clinically significant insomnia. The ISI has been validated for use with healthcare professionals and shown to be responsive to mindfulness interventions.
Time frame: At baseline and post-intervention at week 6.
Mean Change from Baseline in Inflammation as Assessed by Circulating IL-6, IL-8, IL-10, TNF-alpha, and IFN-gamma and Molecular Analysis of Gene Expression and Signaling of 19 Pro-Inflammatory, 28 Type I Interferon Response, and 3 Antibody Synthesis Genes
We will utilize an integrated assessment of inflammation that encompasses systemic levels of inflammatory markers, inflammatory gene expression, and promoter-based bioinformatics analyses of specific inflammation-related transcription factors. Each measurement level provides unique and complementary information, offering a comprehensive view of inflammatory activity.
Time frame: At baseline and post-intervention at week 6.
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