Multifaceted ORganizational InterventiONs (M-ORION) project for prevention of depression and anxiety among workers: study protocol for a five-arm cluster randomized controlled trial

Workers in the worksites allocated to this intervention group will be asked to use a web-based app that provides psychoeducation on job crafting for six months. The participants will access the contents by smartphones, tablets, or computers. The contents of the app were based on the theory of job crafting, “the physical and cognitive change individuals make in the task or relational boundaries of their work,” as defined by Wrzesniewski and Dutton [32]. It was developed mainly based on a previous face-to-face job crafting program [33], and includes three types of job crafting (i.e., task, relation, and cognition).

The education program on job crafting contains four sessions, each lasting 10–15 min. First, the app provides lectures about the concept and importance of job crafting. Second, it introduces various examples of job crafting, such as how workers change their tasks or relationships in their working lives to be more desirable. Third, it requires participants to create their own job crafting plans and try them out. After that, they look back at their plan and make a new improved version of the plan. Each session can be taken at any time and at the participants’ convenience. During the intervention period, participants will be recommended to try various job crafting plans by using the app. If they have any questions or comments about the app, they will be able to contact researchers by e-mail. To encourage participants to use the app, a reminder e-mail by the researcher will be sent once a week for the first month, and once a month from the second to the sixth month.

Supervisors at the worksites allocated to this arm will be asked to take an online-based training program named “Maximize Team Capabilities! Workplace Psychological Safety Navigation” for six months. The program is mainly based on the rationale of team psychological safety by Edmondson [34]. Psychological safety is defined as a shared belief that the team is safe for interpersonal risk-taking (i.e., doing learning behavior that may place workers at risk, including seeking feedback, sharing information, asking for help, talking about errors, and experimenting).

This program provides an explanation of the rationale and importance of team psychological safety at work, how to promote team psychological safety, and specific actions for supervisors to build team psychological safety. The program also provides information on how to support subordinates who may be experiencing mental problems or concerns (i.e., how to notice changes in their health, approach them, and encourage consultation with mental health professionals). This program comprises four video lessons and e-newsletters. The videos will be released on YouTube, one per week during the first month. The videos are approximately 15 min each and can be viewed as many times as participants like. The e-newsletter will be delivered three times a week during the first month, and then once a week from the second month to the sixth month. The e-newsletters offer lesson summaries, encourage viewing for those who have not watched, and provide specific examples of actions to promote team psychological safety in the workplace.

Workers in the worksites in this intervention group will participate in the Participatory Work Environment Improvement Program (PWIP) [35] for 7–12 months, which focuses on improving the psychosocial factors of the workplace. It is based on participatory organizational interventions and participatory approaches that are undertaken to respond to local needs at each workplace [36]. This program will be conducted by internal facilitators who will be selected in each workplace and will assess, facilitate, and provide suggestions for the PWIP. The external coordinators (i.e., the research team) will contact, train, and support the internal facilitators to conduct the PWIP program.

First, a single, 120-min training session for the internal facilitators will be held immediately after allocation. Next, the internal facilitators will assess the readiness of the PWIP by using the Basic Organizational Development for Your workplace (also known as BODY) checklist [37]. This checklist consists of five items and classifies readiness of the workplace into four levels (from 0–4). The PWIP will be tailored based on the proportion of workers with affirmative answers to the Basic Organizational Development for Your workplace items, as follows: for a workplace classified as level 2 or 3, the standard PWIP program will be conducted; for a workplace classified as level 0 or 1, the external coordinators increase the frequency of contact and support for the internal facilitators. The planning and application of the PWIP will be supported by a web-based app. Workers will access the app to identify the favorable conditions and conditions that need improvement in the workplace, participate in group work, and contribute to the improvement of the workplace [38]. The PWIP consists of three sessions, as described herein: 1) a kick-off work (first time), encompassing a brief workplace-level workshop, which in turn uses a) presentations of local good examples, b) action checklists listing typical low-cost actions [39], c) group work guidance materials on the website for job stress prevention; 2) follow-up/planning and actions (1–3 months later), including workplace-level feasible multifaceted improvement plans, which in turn will be devised by encouraging consensus building and facilitating actions at each work unit or workplace; 3) report and shared achievements (6–12 months later), emphasizing locally-achieved good practices that improved working conditions and worker safety and health.

Workers in the worksites in this intervention group will be asked to install a smartphone app on their smartphone and use it for six months. The app is named ASHARE, and is a native app for iOS and Android smartphones, supporting version 12.0 or later in iOS and version 5.0 or later in Android [40]. The iOS and Android versions of the app are distributed via App Stores and Google Play, respectively.

The app was developed to promote physical activity and prevent depression and anxiety in a healthy working population, and is based on basic behavioral change techniques (i.e., self-monitoring, feedback, and sharing of users’ physical activity data). Moreover, the needs of workers identified through qualitative interviews in a past study were reflected in the functions and interface of the app [41]. When users install the app, they are initially asked to register their username and email address and input their age, gender, occupation, employment status, shift type, working hours per week, holiday patterns, and preferred activities. The app works with Apple Healthcare (iOS) and Google Fit (Android) and obtains data on the duration of moderate-to-vigorous physical activity every 15 min [42]. These data are stored on a cloud server. The duration of the overall physical activity on the previous day is depicted as a graph on the top screen of the app.

In addition, the deep-learning model embedded in the app accesses the data for the previous day on cloud servers when the user starts the app and predicts a score of psychological distress for the day, which in turn is measured using the six-item Kessler Psychological Distress Scale (K6) [43]. Every day, participants are provided with feedback on predicted scores and levels of distress, which are presented as weather conditions, accompanied by rule-based comments from a monkey anime character (mental health forecast). A previous study on the predictive performance of the deep-learning model underlying the ASHARE app reported that the correlation coefficient between the predicted and measured values for psychological distress was 0.679 (R2 = 0.463), and that the overall classification accuracy for levels of psychological distress was 76.3% [44]. The predicted scores and levels of psychological distress are recorded and monitored on a monthly basis.

The ideal usage of the app, as expected by the researchers, is for the participants to take about 5 min every day to open the app, check their physical activity patterns and the results of their mental health forecast, and to then increase the amount of any type of moderate-to-vigorous physical activity. As a function of data sharing, users with a high percentage of sunny days are ranked as “best performers.” Rankings can be modified freely based on categories such as age, gender, occupation, and preferred activities. If users are reluctant to share data with other users, they can decline to participate in the ranking process. The app has a notification function that notifies users on the smartphone of new information and the result of the mental health forecast (provided at six o’clock every morning). The reminders for app use will be sent once a week using this function.

Workers in the worksites in this group will be asked to download and read a booklet with basic information about stress, and to complete a simple individual work for six months. The booklet is a 14-page PDF file comprising explanations about differences between stressors and stress reactions (or strain); stress-performance curve (i.e., Yerkes–Dodson law) [45]; stressful life events [46]; and National Institute for Occupational Safety and Health (also known as NIOSH) model of job stress [47]. It also includes a worksheet to write down the acute reactions (i.e., psychological, physiological, and behavioral) that are likely to occur when the participants themselves are placed in stressful situations. Since this is a control group, as a rule, no assistance other than the distribution of the booklet will be provided.

To improve adherence (completion rates) to the programs, reminders will be sent to participating worksites and employees via email and/or applications during the program duration. The reminders will include greetings, a recommendation to work on the contents of assigned programs, and the sharing of the statistics of the completion rates at other worksites within the arms (e.g., mean rates and champion worksite). Completion rates will be monitored using the digital records of the intervention and active control programs. At each survey point, reminders to complete the questionnaire will be sent weekly. These process evaluations of the cRCT will be summarized immediately after each survey (at the 6-, 12-, and 18-month follow-ups) and sent to the participating worksites and employees with a letter thanking them for their cooperation.

Depression and anxiety (non-specific psychological distress) will be measured using the Japanese version of the K6 scale [43]. It comprises six items that assess the frequency of experience of non-specific psychological distress, which are rated on a five-point Likert scale (0 = none of the times and 4 = all the times). The reliability and validity of the Japanese version of the K6 have been confirmed previously [43]. In this study, the total score for the K6 scale will be considered an indicator of depression and anxiety.

Job stressors, stress responses, and psychological safety will be measured as indicators of psychosocial factors at work. Job stressors include job demands, job control, and social support from supervisors and coworkers, which will be measured using subscales of the Brief Job Stress Questionnaire (BJSQ) [48]. The BJSQ was developed in 2000 in Japan and has been widely used in occupational health studies and practice [49]. The subscales for job stressors comprise three items each and are job demands, job control, supervisor support, and coworker support. All items are rated on a four-point Likert scale (for job demands and job control: 1 = not at all, 4 = very much so; for supervisor and coworker support: 1 = not at all, 4 = extremely). The total subscale scores will be calculated.

Stress responses will also be measured using the BJSQ, and the subscales are vigor (three items), anger-irritability (three items), fatigue (three items), anxiety (three items), depression (six items), and physical complaints (11 items). All items are rated on a four-point Likert scale (1 = almost never, 4 = almost always). The total subscale scores will be calculated.

Psychological safety will be measured using the Japanese version of the Psychological Safety Scale (also known as PSS) [50]. It assesses workers’ perceptions of the consequences of interpersonal risks in the workplace and consists of three subscales: team leader (nine items, e.g., “If I had a question or was unsure of something in relation to my role at work, I could ask my team leader”), peers (seven items, e.g., “I can communicate my opinions about work issues with my peers”), and team as a whole (three items, e.g., “It is easy to ask other members of this team for help”) [51]. All items are rated on a seven-point Likert scale (1 = strongly disagree, 7 = strongly agree). The total subscale scores will be calculated.

The nine-item Japanese version of the Utrecht Work Engagement Scale (also known as UWES) will be used to assess work engagement [52]. It consists of three subscales, namely vigor (three items, e.g., “At my job, I feel strong and vigorous”), dedication (three items, e.g., “I am enthusiastic about my job”), and absorption (three items, e.g., “I am immersed in my work”). All items are rated on a seven-point Likert scale (0 = never, 6 = always). The reliability and unidimensional validity of the Japanese version of this scale have been confirmed previously [52]. The average scores from each of the nine items will be used for analyses.

Health-related QOL will be measured using the Japanese five-level version of the scale by the EuroQoL group (also known as EQ-5D-5L) [53]. It consists of five dimensions of QOL (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression). Each dimension has five levels for perceived problems, and a higher score indicates a higher QOL. We will use the value set of the Japanese version of this scale that has been developed in previous research [54].

Job and life satisfaction will be measured as indicators of subjective well-being using questions from the BJSQ [48, 49], with one item for each: “I am satisfied with my job” and “I am satisfied with my family life,” respectively. The two items are rated on a four-point Likert scale (1 = dissatisfied, 4 = satisfied), with higher scores indicating higher satisfaction.

The Japanese version of the Workplace PERMA Profiler will also be used as a multidimensional concept of well-being [55]. This scale is based on Seligman’s PERMA model, and consists of five domains: positive emotion (P), engagement (E), relationships (R), meaning (M), and accomplishment (A) [56]. An overall score of well-being at work is calculated as the average of 15 items (three items each for five dimensions) and happiness (one item). All items are rated on an 11-point Likert-type scale (ranging from 0–10; e.g., for the first item of positive emotion, 0 = never and 10 = always). The reliability and validity of the Japanese Workplace PERMA Profiler have been confirmed previously [55].

Economic outcomes include work performance, absenteeism, worksite turnover, and monthly salary and yearly bonuses. Work performance will be assessed using an item for the absolute score of work performance from the Japanese version of the World Health Organization Health and Work Performance Questionnaire short version (also known as WHOHPQ) [57]. The item rates an individual’s overall job performance in the past month on a scale of 0‒10 (0 = worst job performance, 10 = best job performance). The ratings are multiplied by 10 to calculate work performance according to the scoring guidelines.

Regarding absenteeism, data on absent days in the year before the surveys, monthly salary, and yearly bonus will be obtained from the worksite database at the time of the baseline survey and the 12-month follow-up survey. Regarding worksite turnover, data on the employees leaving the worksite will be obtained at the 12-month follow-up survey.

Data on physiological outcomes, based on the annual health checkups conducted by the participating worksites, will also be collected at baseline and at the 12-month follow-up surveys. These outcomes include height, weight, waist circumference, blood pressure, blood lipids, and blood glucose levels.

In total, 800 employees will be asked to clip extended fingernails into a zip-lock plastic bag for one month, and cortisol levels will be measured from the nail samples. This procedure will be conducted at baseline and at the 6- and 18-month follow-ups. During sample collection, health conditions and lifestyle topics associated with cortisol levels and fingernails will be assessed using a self-reported questionnaire. The questionnaire will include items on marital status, educational background, income, medical history, current medications, pregnancy/childbirth in the previous year, smoking and drinking habits, frequency of cutting nails, frequency of using manicures, how to shorten nails (cut only or cut and file), habit of biting nails, frequency of soap use, frequency of hand disinfection, and frequency of kitchen detergent use.

For process evaluation, the completion rates of the intervention and active control programs will be collected from the digital records of the programs. Implementation outcomes will be assessed using the Implementation Outcome Scales for Digital Mental Health (also known as iOSDMH), which was shown to have acceptable reliability and validity [58]. This assessment tool was developed to measure the implementation outcomes of mental health interventions delivered by digital and telecommunication technologies, and comprises the following five subscales: acceptability (three items), appropriateness (four items), feasibility (six items), overall satisfaction (single item), and harm (five items). These evaluations will be conducted immediately after each intervention.