A Mindfulness-Based Intervention to Reduce Stress Through the Cultivation of Loving-Kindness, Compassion, Joy, and Equanimity in Healthcare Professionals

NCT ID: NCT07283744

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-10
• Study Completion Date: 2027-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Stress (Psychology); Inflamation; Psychosocial Functioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Kindness and compassion-based meditation program

Half of the participants will be randomly assigned to participate in the meditation intervention. This class will meet virtually once a week for six consecutive weeks, for one hour.

Group Type: EXPERIMENTAL

Building Emotional Strength Training

Intervention Type: BEHAVIORAL

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.

Waitlist control

Half of the participants will be randomly assigned to the waitlist control. Participants assigned to this condition will have the opportunity to attend the meditation course after data collection is complete.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Building Emotional Strength Training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1) full-time physician (M.D. or D.O.), 2) at least 18 years of age, 3) able to attend the six-week intervention, 4) fluent in English, and 5) access to the internet and email.

Exclusion Criteria. 1) having a current and consistent meditation practice (i.e., engaging in a formal meditation practice at least three days per week for five minutes each day), 2) previous participation in a Four Immeasurable course (e.g., attending a Brahmaviharas meditation retreat), 3) absence of at least mild levels of perceived stress as determined by a score less than five on the four-item Perceived Stress Scale (PSS-4; 92), 4) regular tobacco use (given its impact on immune function; 90), and 5) failure to agree to the informed consent. The presence or absence of perceived stress will be assessed using the PSS-4 during the initial phone screening.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Julienne Bower, PhD

Area Chair: Health Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julienne E Bower, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles, Psychology Department

Locations

University of California, Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

J Richard T Korecki, M.A.

Role: CONTACT

tkorecki@g.ucla.edu

17204950812

Julienne E Bower, Ph.D.

Role: CONTACT

jbower@ucla.edu

310-825-3004

Facility Contacts

J Richard T Korecki, M.A.

Role: primary

tkorecki@g.ucla.edu

7204950812

Other Identifiers

IRB-25-1518

Identifier Type: -

Identifier Source: org_study_id