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Study protocol for evaluating the efficacy of Mindfulness for Health Professionals Building Resilience and Compassion program: a randomized, waiting-list controlled trial

Tamura, Norikoa; Park, Sunreb; Sato, Yasukoc; Takita, Yukad; Morishita, Jyunkoe; Ninomiya, Akiraa; Kosugi, Teppeia; Sado, Mitsuhiroa; Mimura, Masarua; Fujisawa, Daisukea,f,∗

Author Information
Journal of Psychosocial Oncology Research and Practice: June 2020 - Volume 2 - Issue 2 - p e22
doi: 10.1097/OR9.0000000000000022

Abstract

Introduction

Perceived stress and burnout are common phenomena among medical professionals,[1–3] and have substantial clinical impact. It has been known that they are associated with decreased job satisfaction, decreased professional work effort, lower job productivity, increased absenteeism, and high staff turnovers.[4–7] They may affect the quality of patient care, such as decreased patient satisfaction, longer post-discharge recovery time, and increased medical errors.[4,8,9] There is increasing awareness on medical professionals’ burnout and its impact on their mental health and well-being. Indeed, the US national organizations have recently called for all health care systems to assess their physicians’ well-being with a focus on burnout.[10,11]

Medical professionals in oncology and palliative care are at greater risk of burnout.[12–14] They are responsible for addressing complex needs of patients and caregivers,[15] and they constantly face suffering and death of people that they care for. Working in such clinical settings requires advanced technical knowledge, and relational and human competencies.[16–19]

Both organizational approaches and individual-focused approaches have been proven effective for alleviating medical professionals’ stress and burnout.[20] The latter approaches include a series of psychological interventions such as relaxation training, stress-management programs, cognitive behavioral therapy,[21,22] and recently mindful-based interventions.[23] Theoretically, acceptance-based psychological approaches (eg, mindfulness-based interventions) may be more beneficial than problem-focused approaches (eg, cognitive behavioral therapy) for medical professionals who take care of patients with life-threatening conditions. Problem-focused approaches are useful when there are specific tasks to be done to solve the problems; however, they can be more problematic than helpful when the problem does not have apparent solutions. When people adopt this approach and face a limitation, in response to a feeling of a loss of control, many people “try even harder to control some aspects of their lives and solve the problems, but this is often a losing battle.”[24] For example, a physician may propose a new treatment regimen to treat the illness even though they know there is very little chance of effectiveness while it accompanies a substantial burden to patients. In contrast, acceptance-based approaches such as mindfulness-based interventions allow people to embrace uncertainty and to learn how to accept fundamental inability to control or change the course of illness progression (and ultimately death).[24]

Effectiveness of compassion-based interventions are also gaining attention.[25,26] Compassion, which can be defined as “a virtuous response that seeks to address the suffering and needs of a person through relational understanding and action,”[27] is one of the key elements of quality health care.[28] It can alleviate patients’ anxiety and improve their quality of life while decreasing the use of health care resources.[29] Facilitating medical professionals’ compassionate care is also beneficial to medical professional themselves. It can improve their self-awareness, clinical communication skills, caregiving competence, satisfaction with their care and with their job as a whole, and workplace wellness. Compassion has been featured in professional organizations’ code of ethics,[30,31] and its clinical relevance seems self-evident; however, a recent report claims paucity of the practice of compassion in health care and recommends that system-wide standards of compassionate care should be implemented.[32]

With these issues in mind, we have developed the “Mindfulness for health professionals building resilience and compassion program (MaHALO program).” This program aims to cultivate mindfulness and compassion in medical professionals, thereby raise their resilience and decrease their perceived stress and burnout. The program considers mindfulness, compassion, intention, and quality communication as 4 core abilities for medical professionals to cope with pain and loss that they encounter in clinical practice. The program has 3 unique points. First, it comprises both contemplative and interactive components. We adopted contemplative elements form mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT). For interactive elements, we have been inspired by a well-established existing mindfulness program for medical professionals by Krasner et al.[33] and the G.R.A.C.E. intervention.[34,35] The G.R.A.C.E. intervention provides practical guidance for medical professionals to embody compassionate care represented as G.R.A.C.E. (G: gathering attention, R: recalling intention, A: attunement to self and others, C: considering what will serve, E: engaging and ending). Second, the program is curated so as to be acceptable for busy medical professionals. The standard mindfulness-based interventions are in 8 weekly 2-hour group format,[33,36] which are often difficult for medical professionals to complete.[37–39] Our program is a 2-day weekend workshop followed by 8 weeks of self-practice that the participants can continue among their daily routines. Third, we provide support via the Internet during the eight weeks of self-practice in order to maintain the participants’ sense of connectedness while not meeting each other.

In our previous feasibility study of the MaHALO program, 28 medical professionals who engaged in palliative care entered the study and 26 completed the program. We observed significant improvement in their perceived stress (pre: 28.7 ± 6.7, post: 23.3 ± 7.1, P < .01) and burnout symptoms as represented in the burnout index[40] (pre: 9.6 ± 15.6, post: 2.9 ± 15.0, P < .05). We observed no significant adverse events and received positive feedbacks from most of the participants (>90% of the participants were satisfied with the program and found the program useful).[41] Therefore, in the current study we plan to examine the effectiveness of the MaHALO program in a randomized controlled study design.

Objectives

The aims of this study are to examine whether the MaHALO program reduces the psychological stress of medical professionals in oncology or palliative care, improves other clinical outcomes such as burnout, mood state, subjective wellbeing, resilience, compassion fatigue, compassion satisfaction, self-compassion, and quality of life, and contributes to patient-related outcomes such as medical safety and job performance.

Materials and methods

This protocol is reported in accordance with the Standard Protocol Items: Recommendations for Intervention guideline[42] (Supplement 1, http://links.lww.com/OR9/A7).

Study design

This is a randomized controlled study. The participants will be randomized (1:1) with a block size of 4 without stratification to the intervention group (MaHALO group) or the control group (wait-list group) by using a computer-generated randomization number table. The table will be handled by the person who is independent of the study team.

Participants

Eligible participants are medical professionals who age between 20 and 65 years, work in the field of oncology and/or palliative care, feel psychological distress or difficulty, are able to participate in the whole program, and submit written informed consent. The participants are excluded if they are unable to be followed up for 12 weeks, have experience of formal mindfulness-based interventions, have a history of active psychiatric illnesses within 2 years, or have serious physical or mental conditions to hinder full program participation.

Recruitment

Participants are recruited through the official website of the study group. The website is announced at relevant academic conferences and through the mailing lists of Japanese palliative-care clinicians. The potential participants apply for the program online. If the applicant fulfills the eligibility criteria, the applicants will be asked to submit written informed consent and the baseline-assessment questionnaires by post. Then they will be randomly allocated to either the intervention group or the control group. The participants’ flow is shown in Figure 1.

Figure 1
Figure 1:
CONSORT flow diagram.

Interventions

Intervention group

The intervention group will receive the MaHALO program. The program starts with a 2-day weekend workshop. In this workshop, the participants will receive lectures on mindfulness and compassion, experience a series of mindfulness meditations, and engage in interactive exercises to cultivate mindfulness and compassion in workplace contexts (Table 1). For example, in an exercise named “mindful listening and talking," the participants work in pairs. One person asks another person, “Tell me one of your unforgettable clinical experience or a clinical experience that casted significant impact on you.” After taking some time to think mindfully, a person who was asked is going to talk about his/her experience, and the other person listens to it mindfully. While doing this, the participants are asked to pay attention (to be mindful) to their feelings, thoughts, and physical sensations that may arise.

Table 1
Table 1:
Program components.

Then, the participants will be instructed to practice mindfulness and compassion meditations for 8 weeks as homework. The contents of the homework mimic those of standard MBCT program, consisting of formal and informal meditational exercises (Table 2). The participants will be provided with a workbook to support doing the homework. The workbook has weekly instructions, and the participants are invited to take notes on their daily experiences in terms of mindfulness and compassion. The workbook has a “Today's ABC” section on every page, which provides a short sentence to facilitate participants’ mindful awareness and compassion (eg, A: attention—what do you feel when you drink coffee? B: breathing—remember you can always come back to your breath). Also, the participants will be invited to a blog entry where they can communicate with the program instructors and other participants so that they will be able to feel connected while not meeting each other. The participants will be encouraged to post a note on the blog about their daily mindfulness experience at a designated date during the 8 weeks.

Table 2
Table 2:
Homework contents.

Two follow-up sessions will be held at 4th and 8th week, which take 2.5 hours each. The participants will be invited to share their experience of the past 4 weeks with other participants, will practice additional meditations, and will take part in role-plays with other participants to acquire compassionate communication skills.

The program will be facilitated by psychiatrists, nurses, and clinical psychologists who have 5 to 7 years of mindfulness experience, have undergone MBCT training provided by the Oxford Mindfulness Center, and have completed a course of the G.R.A.C.E. intervention. Progress of the intervention will be monitored based on the agenda checklist by direct observation by a research assistant. Also, the sessions will be video-recorded to assure therapists’ adherence to the intervention protocol.

Control group

The participants who are allocated to the control group will undergo 12 weeks of observation period. They will be invited to participate in the MaHALO program afterwards. They are prohibited to participate in any other mindfulness-based program during the observation period.

Assessments

Assessments will be conducted at 4 timepoints: upon consent (baseline: T1), at 4th week (T2), at 8th week, which correspond to the end of the MaHALO program for the intervention group (T3), and at 12th week (T4) (Table 3). The participants in the control group will be further asked to receive assessments at 4, 8, and 12 weeks after they have started participating in the MaHALO program.

Table 3
Table 3:
Schedule of enrolment, interventions and data collections

Blinding

Due to the nature of this study design, the randomization status cannot be blinded to participants and therapists. Because all the outcome measures are self-reported, there will be no assessors to judge the state of participants.

Measurements

Primary outcome

The primary outcome of this study is the Perceived Stress Scale (PSS).[43] The PSS is a 14-item self-administered questionnaire to evaluate perceived stressful experience or stress responses over the previous month. Each item is in a 5-point Likert format (scoring of 0 = never to 4 = very often). Total scores range from 0 to 40, with higher scores representing higher stress levels.

Secondary outcomes

The following evaluations will be conducted to examine various aspects of effect of the MaHALO program—both negative (eg, burnout and distress) and positive (eg, positive mood and well-being). Some of the scales will be used as to process measures (eg, mindfulness, compassion, and interoceptive awareness).

Maslach Burnout Inventory–Human Service Survey (MBI-HSS). The MBI-HSS is a 22-item self-administered questionnaire to measure the level of burnout in professionals working in human services such as health care. This instrument consists of 3 subscales: emotional exhaustion, depersonalization, and personal accomplishment.[44] Each item is in a 7-point Likert format (scoring of 6 = every day to 0 = never). For the subscales of emotional exhaustion and depersonalization, higher scores indicate a high tendency of burnout, and for the personal accomplishment subscale, lower scores indicate a high tendency of burnout.

The Shortened Version of the Profile of Mood States (SV-POMS). The SV-POMS is a 30-item self-administered questionnaire that assesses 6 dimensions of present mood: tension-anxiety, depression-dejection, anger-hostility, vigor, fatigue, and confusion on a 5-point Likert scale (4 = very often to 0 = never).[45] Higher score indicates unfavorable mood state.

The Satisfaction with Life Scale (SWLS). The SWLS is a self-administered questionnaire with 5 questions to assess a person's life satisfaction.[46] The score for each item ranges from 7 (strongly agree) to 1 (strongly disagree). Higher scores indicate higher satisfaction in life. This scale is considered a standard instrument to measure subjective wellbeing.[47]

The Connor-Davidson Resilience Scale (CD-RISC). The CD-RISC is a self-administered scale to quantify perceived resilience over the past month.[48] The scale contains 25 items, all of which carry a 5-point range of responses (4 = almost always to 0 = never). The scale serves as a reference for resilience, and its sensitivity to change due to treatment has been proven in a clinical population. The total score ranges from 0 to 100, with higher scores reflecting greater resilience.

The Compassion Satisfaction and Fatigue Test (CSFT). The CSFT is a self-administered scale to measure compassion fatigue and compassion satisfaction, originally developed by Figley and Stamm.[49,50] We use its Japanese version, which comprises 34 items with 8 subscales.[51] The factors of compassion fatigue include a substitutional trauma, denial feelings, PTSD-like state, and traumatic experience of a care provider. The factors of compassion satisfaction include satisfaction in relations with fellow workers, satisfaction in relations with patients, satisfaction as nature of care provider, and feeling of satisfaction in life. The degree of compassion fatigue and compassion satisfaction is computed separately. The higher scores indicate higher degrees of each component.

The Five-level EuroQoL-5 Dimensions (EQ-5D-5L). The EQ-5D-5L is a 5-item scale to measure health-related quality of Life (HRQOL). It is considered a standard HRQOL measurement which is applicable across a wide range of health status and treatments.[52] The higher scores indicate higher levels of quality of life.

The Self-Compassion Scale (SCS). The SCS consists of 29 items and assesses people's ability to be kind and understanding toward themselves, as opposed to harsh and self-critical in instances of pain or failure.[53,54] The instrument consists of 5 subscales (self-kindness, self-judgment, common humanity, isolation, mindfulness, over-identification). The scores of each subscale are computed as the mean of each subscale's item scores, ranging from 1 to 5. The higher scores indicate being more self-compassionate.

The Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a 39-item, self-reported scale to assess mindfulness skills.[55] It measures 5 domains of mindfulness skills—observing, describing, acting with awareness, nonjudging of inner experience and nonreacting with inner experience. This scale will be used as a process measure of the intervention—to measure whether the participants have taken up mindfulness skills. Each item is in a 5-point Likert format (scoring of 5 = always to 1 = never). The higher scores indicate greater skills in mindfulness.[56]

The Multidimensional Assessment of Interoceptive Awareness (MAIA). The MAIA is a 32-item self-report instrument to measure perceived interoceptive awareness. Interoceptive awareness has been regarded as an essential factor in meditation and stress reduction.[57] The MAIA has been widely used for experimental interoception research and for assessment of mind-body therapies.[58] The scale consists of 8 dimensions: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Each item is in a 5-point Likert format (5 = always to 1 = never). The higher scores indicate better interoceptive awareness.

The World Health Organization Health and Work Performance Questionnaire (HPQ). The HPQ is a self-report instrument to estimate a loss of productivity due to sickness absence (absenteeism) and reduced job performance (presenteeism).[59,60] Participants answer their job performance over the past month on an 11-point Likert scale (10 = the best performance to 0 = the worst performance).

Sociodemographic data (sex, age, profession, subspecialty, and years of clinical experience) and recent working conditions including average working hours, overwork hours, and recognition of medical errors[61] will be collected. Also, the participants will be asked to report the time they spent on doing homework.

Sample size

The sample size was calculated based on the effect size of the meta-analysis of mindfulness-based intervention.[23] According to the results of our pilot study,[41] we consider that our program will be able to achieve this effect size. Setting the power of .8 and 2-sided alpha at .05, 31 participants are required in each arm. We estimated the dropout rate as 10%, resulting in 70 target participants in total.

Statistical analyses

The mean difference in the PSS between the baseline (T1) and at 8 weeks (T3) will be analyzed as the primary endpoint. The mean difference in total scores and subscale scores of other scales between the baseline (T1), at 4, 8, and 12 weeks (T2, T3, T4) will be analyzed as secondaries. We will adopt both intent-to-treat analyses and per-protocol set analyses. We will adopt mixed-effects models for repeat measures to address dropouts. The outcomes will be adjusted with time, group, time × group, baseline data, age, sex, profession, and time after baseline evaluations. A 5% significance level will be adopted for all statistical analyses. All the analyses will be performed using the SAS 9.4. We will conduct thematic analyses for post-treatment interview data.

Ethical considerations

This study protocol has been approved by the institutional review board of Keio University School of Medicine (Ethical approval number: 20170326) and complies with the declaration of Helsinki and the Ethics Guideline for Clinical Studies of 2009 implemented by the Japan Ministry of Health, Labor, and Welfare. The study was registered in the Japanese Clinical Trial Registry (registry ID: UMIN000031435).

Discussion

This article presents the protocol of a randomized controlled, waiting-list comparison study to examine the effectiveness of the MaHALO program in terms of reducing medical professional's psychological stress and burnout. The unique feature of the program is that we have elaboratively combined contemplative and interactive exercises to cultivate medical professionals’ mindfulness and compassion. The advantage of the program is its format, consisting of a 2-day workshop and 2 follow-up sessions, which we believe is easy for busy medical professionals to participate. Using a workbook and blogs will help participants feel connected while not meeting each other.

There is a methodological limitation of this study. We set wail-list control due to ethical consideration. Since systematic burnout prevention or improvement programs have not been established in Japan, we used a wait-list control rather than using an active control. Using of the wail-list control may overestimate the effect of the intervention program compared to no-treatment control or psychological placebo[62]; therefore, we need to interpret the results cautiously. Further, our program does not directly handle the system barriers or team-related issues that may be associated with stress and burnout medical professionals.

In conclusion, our MaHALO program has the potential to cultivate mindfulness and compassion in medical professional and raise their resilience to cope better with difficult situations, which may subsequently lead to a reduction of their perceived stress and burnout.

Conflicts of interest statement

The authors declare that they have no financial conflict of interest with regard to the content of this report.

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Keywords:

Burnout; Caregivers; Compassion; Mindfulness; Psychological Stress

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