Project FIERCE - Fostering Internal and External Respect, Compassion, and Equanimity: A Mindfulness-Based Intervention to Reduce Stress Through the Cultivation of Loving-Kindness, Compassion, Joy, and Equanimity in Healthcare Professionals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline in Perceived Stress as Assessed by the Perceived Stress Scale
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •. 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.
结局指标
主要结局
Mean Change from Baseline in Perceived Stress as Assessed by the Perceived Stress Scale
时间窗: At baseline, mid-course at week 3, and post-intervention at week 6.
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.
次要结局
- 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(At baseline and post-intervention at week 6.)
- Mean Change from Baseline in Depressive Symptoms as Assessed with the Center for Epidemiological Studies Depression Scale(At baseline and post-intervention at week 6.)
- Mean Change from Baseline in Burnout as Assessed with the Maslach Burnout Inventory for Medical Personnel(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(At baseline and post-intervention at week 6.)
- Mean Change from Baseline in Sleep Quality as Assessed with the Insomnia Severity Index(At baseline and post-intervention at week 6.)
研究者
Julienne Bower, PhD
Area Chair: Health Psychology
University of California, Los Angeles