2.1. Study organisation
The proposed study is a cluster randomised controlled trial (CRCT) that uses a mixed-methods design (quantitative and qualitative, online questionnaire, telephone and face-to-face interviews) and contains four measurement moments (see Figure 2). The Ethics Committee Practice based Research of het HAN University of Applied Sciences (ECPR) and the Medical Ethics Committee (METC) of Radboud University Medical Centre, both located in Nijmegen, the Netherlands, approved the research proposal (Registration no. ACPO 07.12/15; File number CMO: 2019-5266). Both committees stated that the research complied with the requirements of ethical conduct of research as set out in the national Code of Conduct for Scientific Integrity in the Netherlands and that it fulfilled the criteria of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects. The study will be carried out in the Netherlands in full compliance with the applicable rules concerning the review of research ethics committees. Participation is voluntary and participants can withdraw at any moment with no consequences. The study title given to the potential participants and other stakeholders is: ‘Mindfulness and job satisfaction of teachers in secondary vocational schools’. Participants will sign informed consent forms before participating in this study. They will be asked if they agree to use of their data should they choose to withdraw from the trial. This trial does not involve collecting biological specimens for storage.
Significant deviations of the protocol will be documented using a breach report form and will be sent to the funder NWO and to the Ethics Committees. The protocol in the trial register will be updated. A Standard Protocol Items Recommendations for Interventional Trials (SPIRIT 2013) checklist (see Additional file 1) and figure (see Table 1) are provided.
Table 1: SPIRIT checklist
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Study period
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Enroll-ment
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Allo-cation
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Before start
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Post-allocation
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TIMEPOINT**
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t0
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Inter-vention
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t1
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t2
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t3
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ENROLLMENT:
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Eligibility screen
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X
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Informed consent
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X
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[List other procedures]
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X
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Allocation
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X
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INTERVENTIONS:
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MBSR training
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X
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MBSR training and organizational health intervention
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X
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Waiting List Group
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DATA COLLECTION
by on line questionnaire:
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Demographics
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X
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Primary outcome and secondary outcomes
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X
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X
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X
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X
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Other data variables
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X
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X
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X
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X
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DATA COLLECTION
by interviews*:
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Expectations
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X
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X
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Experiences
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X
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X
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* Interviews were only with some participants in MBSR training and MBSR training and organizational health intervention groups
** T0 = before the training; T1 = immediately after the training; T2 = three months after the training; T3 = nine months after the training
2.2. Participants and recruitment
Study participants will be recruited from the teaching staff at no fewer than three secondary vocational schools. When a secondary vocational school agrees to participate, we will recruit potential participants from three programmes (Care, Technology, and Economy) using e-mail, posters, flyers, and each school’s intranet. The researchers, HR consultants, and supervisors will inform potential participants about the research project.
Respondents who are willing to participate will be screened in terms of the eligibility criteria by the first author (MJ) (see Table 2). Eligible candidates will receive an information letter about the project. This letter includes the information as approved by the ECPR and the METC and the informed consent letter. One week before the start of the interventions, cluster randomisation will be conducted and the participants will be informed about their assignment to one of the intervention groups or the waiting list group.
Table 2: Eligibility criteria
Inclusion criteria
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Exclusion criteria
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Teachers in the Care, Technology, and Economy courses
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Attended mindfulness training in the past 2 years
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Employed in a secondary vocational school for at least 2.5 days a week for at least one year
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Attended stress reduction training (e.g., cognitive therapy or relaxation training) in the past 2 years
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2.3. Cluster randomisation
A CRCT is a randomised controlled trial in which not individual subjects (i.e., teachers) are randomised, but groups of subjects (i.e., schools) are [48]. Cluster randomisation will be performed at the school level. This will provide the researchers with the opportunity to study the effects of an additional organisational health intervention that cannot be directed towards selected individuals (i.e., teachers) and to control for ‘contamination’ across individuals (i.e., the effects on one teacher may influence the effects on another teacher in the same course) [49]. In the first secondary vocational school (known as an MBO in Dutch), participating teachers from one course (Care, Technology, or Economy) will be assigned to Intervention Group 1 (IG 1: MBSR), teachers from another course will be assigned to Intervention Group 2 (IG 2: MBSR and an additional organisational health intervention), and teachers from the third course will be assigned to the Waiting List Group (WG). The allocation will be different at each school (see Table 3). A researcher who is not involved in assigning courses/participants to the groups will prepare concealed, consecutively numbered, sealed opaque envelopes. Every envelope will contain a paper indicating the treatment assignment at school level (type 1, 2 or 3). The MBO schools will receive their envelopes from a researcher who is unaware of the randomisation sequence. The MBO schools can open the envelope in the presence of the researcher and the researcher will be informed about the treatment assignment.
There is little evidence for the harmful effects of MBSR [19]. Besides we will recruit participants from a healthy target population. Therefore there will be no special criteria for discontinuing or modifying allocated interventions. In case of (serious) adverse events and harms from the intervention, the participant concerned will be referred to an occupational health professional and the project management group, consisting of the second, third, fifth and sixth author, the funder NWO and the Ethics Committees will be informed. A final decision to terminate the trial will be made by the project management group, deliberating at least every six weeks or more, when necessary.
The trial conduct will be audited by an annual evaluation report for the funding organization NWO. The report is also available for the Ethics Committees and the project management group, which will discuss the progress of the trial every six weeks. The second and sixth author will be responsible for the daily supervision of the trial. The implementation of the interventions and the data collection will be strictly separated.
Table 3: Cluster randomisation
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Care
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Technology
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Economy
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MBO school, type 1
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IG 1a
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IG 2b
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WGc
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MBO school, type 2
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WG
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IG 1
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IG 2
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MBO school, type 3
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IG 2
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WG
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IG 1
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a: IG 1: Intervention group 1 (MBSR)
b: IG 2: Intervention Group 2 (MBSR and an additional organisational health intervention)
c: WG: Waiting List Group (control group that will receive MBSR one year later)
2.4. Procedures
All study participants will be asked to complete an online questionnaire on a secured website before the start of the intervention(s) (the starting date of the study is different for each school) (T0). After completing the questionnaire, the participating schools will be randomly assigned (type 1, 2 or 3; see Table 3), meaning that participants will take part in IG 1, IG 2 or WG depending on the course where they are working. At T0, the first author will conduct 10-minute telephone interviews with at least 12 participants from IG 1, and 12 participants from IG 2 about their expectations of the interventions. All participants will receive the other three follow-up questionnaires on a secured website after the MBSR training (T1), three months later (T2), and nine months after the MBSR training (T3). The first author will conduct face-to-face interviews with at least 12 participants from IG 1 and 12 from IG 2 at T1 and T3. At T1, some members of the participatory group that will be involved in the organisational health intervention – excluding the teachers participating in IG 2 (e.g., a superior, an HR consultant, and the director of the programme) – will be interviewed about the process and effects of the organisational health intervention.
Participants in IG 1 and IG 2 should attend at least four of the nine MBSR sessions, because Bear et al. [50] revealed that structural changes in perceived stress did not occur until four MBSR sessions [19]. Participants in WG will attend a MBSR programme one year later.
The collected data will be stored on a secure disk to ensure confidentiality. Not the researcher but an independent external organization, assigning encrypted numbers to the participants, will collect the data. The researcher cannot link the numbers and the participants. Only the researcher (first author), the members of the project management group and a methodologist (fourth author) will have access to the data.
2.5. Interventions
2.5.1. MBSR: main intervention
MBSR, developed by Kabat-Zinn [51], is the most common form of secular mindfulness-based training [52]. MBSR aims to reduce suffering or stress [53] and was originally developed for patients with chronic pain. This training programme is primarily based on Kabat-Zinn’s curriculum [51], but it contains elements of Mindfulness-Based Cognitive Therapy (MBCT) [54]: in particular, a three-minute breathing space and psycho-education about the nature of thoughts. The MBSR programme will consist of eight 2.5hours weekly group sessions, each with 4–15 participants per group, homework involving 45 minutes of daily home exercise six days a week, and one 7-hours day of silence. The sessions will be supervised by one of the four recruited qualified mindfulness trainers (MC, SL, TvR, WK), who will receive a training script. The first session will begin with a short introduction to the programme and meet and greet between participants. Each session will consist of different meditation exercises, enquiry, psycho-education, and a specific theme (see Table 4). At the end of each session, participants will be asked to do homework that will be discussed in the subsequent session.
Table 4: Content of MBSR group sessions
Session
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Theme
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Content of group sessions
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Homework
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1
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Automatic pilot
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- Introduction
- Raisin-eating exercise
- Body scan
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- Body scan
- Attention to routine activity
- Eating one meal mindfully
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2
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Perceiving clearly
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- Body scan
- Imagery exercise to demonstrate the relationship between thoughts and feelings
- Sitting meditation, paying attention to breathing
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- Body scan
- Attention to breath
- Awareness of pleasant events
- Attention to routine activity
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3
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From doing to being: a mode of doing and a mode of being
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- Lying-down yoga exercises
- Sitting meditation with a focus on breathing, bodily sensations, sounds
- Pleasant events
- Seeing exercise to demonstrate the difference between observation and interpretation
- Three-minute breathing space (mini-meditation)
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- Body scan
- Lying-down yoga exercises
- Attention to breath
- Awareness of unpleasant events
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4
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Be present
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- Three-minute breathing space (mini-meditation)
- Standing yoga exercises
- Unpleasant events; interrelatedness of bodily sensations, feelings, and thoughts
- Sitting meditation with a focus on breathing, bodily sensations, sounds, feelings/ emotions, and thoughts
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- Body scan
- Standing yoga exercises
- Sitting meditation
- Three-minute breathing space
- Awareness of stress reactions
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5
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Recognising and allowing what really is: reacting versus responding
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- Three-minute breathing space (mini-meditation)
- Walking meditation
- Sitting meditation with a focus on breathing, bodily sensations, sounds, feelings/ emotions, thoughts, and random attention
- Automatic stress reactions and stress response
- Mid-term evaluation
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- Meditation by choice
- Three-minute breathing space
- Awareness of difficult situations
- Awareness of reactions in difficult situations
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6
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Mindful communication
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- Standing yoga exercises
- Sitting meditation with a focus on breathing, bodily sensations, sounds, feelings/ emotions, thoughts, and random attention
- Mindful communication exercises
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- Meditation by choice
- Three-minute breathing space
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Day of silence
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Deepen mindfulness skills in silence
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- Various meditation exercises
- Silent lunch and tea break
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7
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Taking care of yourself: balance in life
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- Standing/lying yoga exercises
- Sitting meditation
- Communication exercises
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- Meditation exercises without CD
- Attention to routine activities
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8
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The rest of your life
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- Different exercises
- Own menu of mindfulness exercises
- Maintaining practice: review of supports
- Reflection on training
- Saying goodbye
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- Further sources of information
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2.5.2 Additional Organisational health intervention
The organisational intervention, that will be used in the proposed study, will be developed by following a design-based approach [55] in accordance with the key points of PAR [36] with a grounding in the Job Demands-Resources (JD-R) model [6]. A design-based approach is pragmatic, based on theory, observations and experiences [56]. The organisational intervention will be developed following the steps of the design-based approach (see Figure 3). The JD-R model [6, 45] assumes a relationship between work characteristics (i.e., job demands and job resources) and work outcomes. High job demands lead to stress reactions and unhealthiness (exhaustion process), while high job resources increase motivation and productivity (motivational process).
The organisational health intervention will consist of two phases. In the first phase, the ‘needs assessment phase’, we will conduct a needs assessment using the knowledge, skills, and perceptions of teachers and educational managers to investigate the positive points (job resources) and the main difficulties (job demands) in the specific course. In the second phase, the ‘implementation phase’, the teachers and managers will jointly determine the highest priorities and develop a feasible work-related action/implementation plan.
In the ‘needs assessment’ phase, a participatory group will be formed. It will preferably include two teachers participating in the MBSR training, two other teachers (workplace), the HR consultant for the specific course (expert), a supervisor, the course director (decision-making power), an external facilitator, and relevant others from the workplace (e.g., a union member or a member of the formal employee participation committee).
The focus of the intervention is to stimulate dialogue between management and employees/teachers in which they can jointly investigate improvement opportunities and implement solutions that reduce stress and improve work pleasure. The intervention consists of approximately five sessions (see Table 5), starting with a needs assessment to the implementation of work-oriented solutions.
The programme theory or critical assumptions underpinning the organisational health intervention (How would the intervention work if it were successfully implemented?) [57] are as follows:
- Involving an external facilitator (an expert in organisational change processes) and creating a participatory group that includes teachers, the Human Resources (HR) consultant, the director, and the managers will enable the group to establish the highest priorities and develop solutions to improve the working environment.
- A supported, basic work-related action plan will be developed as well, consisting of: ‘relatively easy and quick to solve’ priorities (= quick wins), solutions, a timeline, necessary resources, and an implementation method.
- The quick wins will be implemented immediately.
- Healthy working in the course will be improved, dialogue between management and employees/teachers will be stimulated, and occupational self-efficacy will be increased.
Table 5: Sessions and content of participatory group sessions
Session
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Content of participatory group sessions
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Phase
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1
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- Introduction
- Mutual expectations, drive and mission/vision. Mutual commitment
- How to engage colleagues?
- First inventory of positive points (job resources) and difficulties (job demands) for work pleasure in the course, as inspired by the JD-R model
(Prioritising based on importance, level of influence, and the wait time for results)
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1
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2
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- Which priorities do we choose?
- Possible solutions
- Action plan
- Implementation plan
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1
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3
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2
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4
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2
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5
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- Follow-up implementation
- Maintaining, continuation, evaluation
- Saying goodbye to the external facilitator
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2
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2.5.3 Waiting list group
The participants on the waiting list will receive MBSR after one year. They cannot attend a mindfulness training course or stress reduction training (e.g., cognitive therapy or relaxation training) until T3.
2.6. Baseline characteristics of participants
Measures regarding the baseline characteristics of the participants are provided in Table 6.
Table 6: Baseline characteristics of participants at T0
Gender
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Age (years)
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Family situation
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Level of education
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Nature of employment; course (Care, Technology, or Economy)
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Years of work experience
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Number of working days and hours
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2.7. Outcome assessments and data collection
2.7.1 Primary outcome
Mindfulness skills will be examined using the Dutch version of the Five Facet Mindfulness Questionnaire (FFMQ-NL), a self-report measure based on a factor analysis of items from the five most widely used mindfulness questionnaires [58, 59]. The 39-item FFMQ-NL has a five-factor structure that is captured in the following five subscales: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. The FFMQ-NL total score ranges from 39 to 195; the total scores of the subscales are 8 to 40, except non-reactivity (7 to 35). Higher values indicate higher levels of mindfulness skills. De Bruin et al. [59] reported an internal consistency (Cronbach’s alpha) for the FFMQ-NL total score of 0.85 (for the non-meditating sample) and 0.90 (for the meditating sample); the Cronbach’s alphas for the five subscales vary from 0.70 to 0.89 [59]. The five dimensions show modest but significant correlations among one another (ranging from 0.13 to 0.39), which suggests that they represent distinct but interrelated constructs [59]. All mindfulness dimensions are positively correlated with meditation experience and negatively correlated with psychological symptoms (i.e., depression, anxiety, insomnia and social withdrawal) [59]. All the dimensions except observing are negatively related to the constructs of alexithymia (lack of ability to identify and describe feelings, and lack of interest in feelings, cognitions and motivations), thought suppression, rumination, worry and dissociation [59]. Overall, the psychometric properties of the FFMQ-NL [62] are comparable to those of the original English version [58].
2.7.2 Secondary outcomes
2.7.2.1 Secondary mental health outcomes
Burnout will be measured using the Dutch version of the Maslach Burnout Inventory – Education Survey (MBI-ES), the Utrechtse BurnOut Schaal-Leerkrachten (UBOS-L; Utrecht Burnout Scale – Education) [60-62]. The 22-item UBOS-L has a three-dimensional structure with the following subscales: emotional exhaustion, mental distance (cynicism, depersonalisation) and (job-related) personal accomplishment/professional efficacy. The total scores of the three subscales range from 0 to 6. Higher values indicate more emotional exhaustion, more mental distance, and more personal accomplishment, respectively. Maslach et al. [60] mentioned Cronbach’s alphas of the three subscales – emotional exhaustion (8 items), mental distance (7 items), and professional efficacy (7 items) – of 0.91, 0.73, and 0.85, respectively. The emotional exhaustion subscale is highly correlated with other mental and physical complaints, and with job demands like time pressure [60]. Mental distance and professional efficacy are significantly related to personal resources like autonomy and ambition level [60].
Stress will be assessed with the 14-item stress scale of the Dutch 42-item Depression, Anxiety, Stress Scales (DASS) [63]. The total score on the stress scale ranges from 0 to 21. Higher values indicate more stress. The DASS has a three-factor structure: depression, anxiety, and stress. Nieuwenhuijsen et al. [63] reported internal consistencies of the DASS of 0.94, 0.88, and 0.93, respectively.
Sleep quality complaints will be measured using the Dutch sleep quality subscale of the 14-item Vragenlijst Beleving en Beoordeling van de Arbeid 2.0 (VBBA2.0; Perception and Assessment of Labour 2.0 Questionnaire). The total score ranges from 0 to 100. Higher values indicate more complaints and lower quality sleep. Van Veldhoven et al. [64] reported an internal consistency (Cronbach’s alpha) of 0.90.
Positive and negative emotions at work will be assessed by the 12-item Dutch version of the Job-related Affective Well-Being Scale (JAWS) [65, 66]. The Dutch JAWS has a two-factor structure, which is reflected in the following two subscales: a positive six-item emotions scale (Cronbach’s alpha = 0.77) and a negative six-item emotions scale (Cronbach’s alpha = 0.78) [66]. The total score on each subscale varies from 6 to 30. Higher values indicate more positive emotions and more negative emotions, respectively. The positive emotions subscale is negatively correlated with the frequency (r = -0.22) and duration (r = -0.23) of future absenteeism of managers; the negative emotions subscale is not correlated with these variables [66].
Work engagement will be assessed using the nine-item Dutch version of the shortened Utrecht Work Engagement Scale (UWES), the UBES-9 [67, 68]. The three-dimensional UWES consists of three 3-item subscales: vigour, dedication, and absorption. The total score on the UWES ranges from 9 to 54. Higher values indicate more work engagement. Schaufeli et al. [67] reported an internal consistency (Cronbach’s alpha) for the total UBES-9 of 0.93 and the alphas for the three subscales vary from 0.79 to 0.89. The three work engagement scales are highly correlated (minimum r = 0.65) [67]. The three factors are negatively correlated with the three dimensions of burnout [67].
Organisational commitment will be assessed by four items derived from the four-item Affective Commitment Scale (ACS) used by Smeek et al. [70]. Smeek et al. [70] reported a Cronbach’s alpha of 0.70.
2.7.2.2 Secondary work performance outcomes
Work performance and work behaviour, defined as behaviours or actions of employees that are relevant to the organisation’s goals, will be measured using the Dutch Individuele WerkPrestatie Vragenlijst (IWPQ; Individual Work Performance Questionnaire) [71]. The 18-item questionnaire consists of three subscales: task performance (5 items), contextual performance (8 items), and counter-productive work behaviour (5 items). The total scores on the three subscales range from 0 to 4. Higher values indicate more task performance, more contextual performance, and more counterproductive work behaviour. The internal consistency (Cronbach’s alpha), reported by Koopmans et al. [71], varies between 0.78 (task performance) and 0.85 (contextual performance). Task performance and contextual performance are moderately positively correlated with work engagement: 0.32 and 0.43, respectively. Counterproductive work behaviour is moderately negatively correlated with work engagement (-0.29) [71].
Absenteeism, working fewer than the normal hours or days in the employment contract due to a health problem, will be measured by four items from the NEA 2018 [72], the Dutch Working Conditions Survey 2018 (e.g., How many working days have you been absent in the last three months? How many times have you been absent in the last 12 months over one or more periods longer than 2 weeks? If so, has the absenteeism to do with your work? Have you fully returned to work now? ).
2.7.3 Mediating variables
2.7.3.1 ‘Personal competencies outcomes’ or ‘process-focused outcome measures’
Occupational self-efficacy, which refers to the confidence a worker has in their perceived ability to perform job tasks successfully, will be assessed using the short (six-item) Dutch version of the Occupational Self-Efficacy Scale [73]. The total mean score ranges from 1 to 6. High values reflect high occupational self-efficacy. Rigotti et al. [73] reported an internal consistency (Cronbach’s alpha) of 0.85.
Taking distance, which comprises not worrying or ruminating about the work at home, will be assessed using the three-item ‘Afstand Nemen’ (Taking Distance) subscale of the VBBA 2.0. The total score varies from 0 to 100. Higher values indicate that the individual experiences more problems with taking a distance from work. Van Veldhoven et al. [64] mentioned an internal consistency (Cronbach’s alpha) of the subscale of 0.80.
2.7.3.2 ‘Work-related perceptions’
The job demands work pressure and emotional demands will be measured using the six-item Werktempo & Werkhoeveelheid (Work Pace and Workload) questionnaire and the five-item Emotionele Belasting (Emotional Demands) questionnaire of the VBBA 2.0, respectively. The total score ranges from 0 to 100. Higher values indicate more work pressure and more emotional demands. Van Veldhoven et al. [64] reported an internal consistency (Cronbach’s alpha) of the subscales of 0.86 and 0.80, respectively.
The job demand balance between work and private life will be assessed using two subscales of the Dutch version of the Survey Work-home Interaction-NijmeGen (SWING): the negative Work-Home Interaction (negative WHI) subscale, which measures negative effects of work on functioning at home and the negative Home-Work interaction (negative HWI) subscale, which measures negative effects of home on functioning at work [74]. The SWING also includes two other subscales: the positive Work-Home Interaction (positive WHI) subscale and the positive Home-Work interaction (positive HWI) subscale. The total score on the negative WHI and the negative HWI ranges from 0 to 3. Higher values indicate more problems in work-home interaction. The internal consistency (Cronbach’s alpha) of the negative HWI and the negative WHI, mentioned by Geurts et al., is 0.72 and 0.85, respectively [74].
The job resources autonomy (4 items), feedback from colleagues and superior (4 items), relationship with colleagues (6 items), relationship with superior (6 items), and relationship with students (4 items) will be measured using several scales of the VBBA2.0. The total score on every scale ranges from 0 to 100. Higher values indicate more problems in the specific outcomes (e.g. a higher score on autonomy indicates less autonomy). The internal consistency (Cronbach’s alpha) of the subscales, reported by van Veldhoven et al. [64], varies from 0.81 to 0.87.
2.7.4 Moderating variable ‘personality characteristics’
The Dutch version of the Ten Item Personality Inventory (TIPI) will be used to measure the dimensions of the Five-Factor-Model of personality: neuroticism, extraversion, openness, agreeableness, and conscientiousness. Each factor will be assessed by two unipolar items with a seven-point Likert scale ranging from 1 = not applicable at all to 7 = completely applicable. The TIPI has been shown to be a valid alternative for the existing extensive Big Five instruments [47].
2.8. Process evaluation of the MBSR training
A process evaluation will be conducted to explore working mechanisms and possible barriers to MBSR in this population. The process evaluation of MBSR will be conducted using both quantitative (online questionnaire, primarily questions about experiences with the MBSR training) and qualitative measurements (semi-structured interviews). All participants will receive the online questionnaire at T0, T1, T2, and T3. A selection of the participants to IG 1 and IG 2 will be interviewed at T0, T1, and T3. The interview at T0, lasting 10 minutes, will be conducted by telephone and will be focused on expectations about MBSR. The face-to-face interview at T1, lasting 25 to 35 minutes, will be about experiences during the MBSR training and its short-term effects. The face-to-face interview at T3, lasting approximately 25 to 35 minutes, will be focused on long-term effects. All interviews will be recorded, fully transcribed, and anonymised. A deductive qualitative analysis will be performed, because of the availability of a focused main research question and a conceptual model [75, 76]. The interviews can provide valuable information about the working mechanisms and possible barriers of the MBSR training.
2.9. Process evaluation of the additional organisational health intervention
A process evaluation of the additional organisational health intervention will be performed to assess the requirements /conditions for successful implementation, based on a simplified version of the theoretical framework presented by Nielsen and Randall [57, 77]. These researchers indicate that a process evaluation is important because the implementation process can moderate or mediate the potential effects of the intervention on health and well-being [57, 77]. Successful implementation is a prerequisite for exposure to the intervention and therefore for entailing possible health effects. The framework, which enables us to link intervention processes to intervention outcomes, will be applied to qualitatively appraise three themes of process components: 1) intervention design and implementation, determining the maximum level of intervention exposure; 2) intervention context; and 3) participants’ mental models [57, 77]. The process components of Themes 2 and 3 may mediate or moderate the link between any intervention exposure and intervention effects [77]. Table 7 lists the themes and requirements/process components for successful implementation that will be assessed in the semi-structured interviews (T1). Applying the framework will help us to understand why the implementation process was successful or not [57].
The process evaluation will be conducted using semi-structured interviews. A selection of participants in IG 2 (taking into account participating in the participatory group or not) and of other participatory group members who are not participating in the MBSR training (e.g., teachers not participating in the MBSR training, or supervisor, director, HR consultant, work council member, trade union member) will be interviewed at T0, T1, and T3.
Table 7: Themes and requirements/process components for successful implementation, based on a simplified version of the theoretical framework from Nielsen and Randall [77]
Themes and requirements
|
Operationalisation
|
- Intervention design and implementation
|
|
Initiation
|
Commitment to the intervention and the motivation of the director and team managers
|
Communication about the intervention at the start
|
Communication to the teachers from the course, the mindfulness training participants, and the participatory group members
|
Participation
|
- Establishment of a participatory group
- Involvement of the teachers in the course and of the participants in the mindfulness training and in the participatory group
|
Targeting
|
Choosing the right problems in the workplace with the possibility of quick wins
|
Satisfaction
|
The teachers’/participants’ satisfaction with the intervention
|
|
|
Organisation’s culture
|
Inherent features of the organisation’s culture that facilitate or impede the implementation of the action plan
|
Conditions
|
The organisation’s capacity and skills to implement the action plan
|
Events
|
Events that interfere with implementation of the action plan
|
- Participants’ mental models
|
|
Readiness to change
|
Employees’ and participants’ readiness to change at T1
|
Perceptions
|
Was the perception of the intervention (action plan) positive?
|
2.10. Sample size
A power analysis (G*Power; version 3.9.1.4) revealed that a sample size of 22 participants in each group (IG 1; IG 2; WG), with at least two repeated measurements would enable detection of a medium effect size (d = 0.50) [78], with a power of 0.95 and an alpha of 0.05. A total sample size of 66 participants is therefore required.
2.11. Blinding
Participants, trainers, facilitator, and researchers cannot be blinded about their assigned intervention after cluster randomisation. All participants have to fill in the online questionnaire at home or at work, excluding the influence of the researcher. The developer of the online questionnaire will collect the data and provide the anonymous data to the researcher. The data analysis by the researcher will be blind.
2.12. Statistical analyses
Baseline characteristics of participants will be presented in terms of means and standard deviations (SDs) for metric variables, and in terms of frequencies and percentages for categorical variables. The outcomes of the questionnaires will be compared at baseline (T0), immediately after the intervention(s) (T1), three months later (T2), and nine months after the intervention(s) (T3). All analyses will be conducted according to the intention-to-treat (ITT) principle. ITT-analysis, based on the initial treatment allocation and not on the treatment eventually received, will avoid the effects of drop-out, which may break the random allocation to the intervention groups [79]. Per-protocol (PP) analyses with the treatment-adherent sample (i.e., participants in IG 1 and IG 2 have to attend at least four of the nine MBSR sessions, and participants in WG cannot attend a MBSR programme or stress reduction training) will also be performed. The aim of PP analysis is to assess the effects of MBSR and the additional organisational health intervention under optimal conditions: What is the effect if participants are fully compliant [80]? Therefore, drop-outs need to be excluded from any PP analysis.
The quantitative short-term and long-term effects of MBSR and the additional organisational health intervention (differences between T0, T1, T2, and T3) will be examined using longitudinal regression analysis (Generalised Estimating Equations, GEE, or mixed models), which is fit to analyse longitudinal/clustered data in clinical trials [81] or repeated-measures designs (General Linear Model, GLM) [82]. The baseline values of outcomes (T0) of the three groups (IG 1; IG 2; WG) will be defined as independent variables, while the outcomes on the follow-up measurements (T1, T2, T3) will be treated as dependent variables. Correction of confounding variables will be applied.
To investigate the working mechanisms (How is mental health improved?) of MBSR and the organisational health intervention, mediating and moderating analyses will be conducted. The mediating effect of personal competencies on mental health outcomes and on work performance outcomes will be tested. The mediating effect of work-related perceptions on mental health outcomes and on work performance outcomes will also be investigated. The moderating effect of the Big Five, especially as regards the factors of extraversion and openness, on mental health outcomes/work performance outcomes will also be examined.
All statistical analyses will be conducted using IBM SPSS Statistics, version 25. The level of significance will be set at 0.05. The analysis of the qualitative data, collected by the semi-structured interviews at T0, T1, and T3, will be deductive [-76], and will be conducted by means of using ATLAS.ti [83].
2.13 Dissemination policy
Results of the trial will be communicated by scientific articles in open access journals, management letters for participants and non-participants of Dutch secondary vocational schools, and articles for professional magazines intended for occupational health professionals.