Abstract
BACKGROUND: Although internet-based stress management programs are proven effective in improving mental health among workers, micro- and small-sized enterprises (MSEs), lacking in occupational healthcare services, face challenges implementing them. To address this gap, this study will develop the program with stakeholders at MSEs to aim for real-world implementation. OBJECTIVES: This paper describes a study protocol for a pre-post feasibility study of an effectiveness-implementation hybrid type 2 trial of text-based internet-based programs ("WellBe-LINE") in MSEs with less than 50 employees. This feasibility study primarily aims to evaluate trial methods for future effectiveness-implementation hybrid type 2 trials. METHODS: For this study protocol, an internet- and text-based self-care intervention program using the LINE app (a popular message tool in Japan) will be prepared according to evidence-based psychoeducational topics. Based on our online survey findings, personalized algorithms will be implemented according to employees' gender, age, and psychological distress levels. A personalized program using a popular pre-existing text app is expected to reduce employees' burdens and be attractive to them, resulting in successful implementation outcomes and mental health benefits. A pre-post design feasibility study will be conducted on ten companies to evaluate trial methods (e.g., recruitment and procedures). The primary outcome will involve individual-level penetration, defined as the proportion of the number of employees who register for the program divided by the total number of invited employees at the company. The progression criterion to go next trial specifies that more than 50% of the recruited companies obtain 60% individual penetration, which is set based on the findings of the prior survey of employees at MSEs and of interviews of stakeholders involved in this study, and will be measured by LINE system. Finally, acceptability, appropriateness, and feasibility will be measured using internet-based questionnaires and interviews. DISCUSSION: This pre-post feasibility study for future effectiveness-implementation hybrid type 2 trials will provide in-depth knowledge about the successful implementation of text-based, semi-personalized, self-care mental health interventions in real-world settings using both quantitative and qualitative data. CONCLUSIONS: This feasibility study will help validate the effectiveness of text-based interventions using a widely used social networking service (SNS) tool for employees in MSEs. TRIAL REGISTRATION: UMIN clinical trial registration, UMIN000046960. Registered on February 21, 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053570.