Implementation of an internet-based stress management program in micro- and small-sized enterprises: A study protocol for a pre-post feasibility study of the effectiveness-implementation hybrid type 2 trial

Background Text-based self-guided internet-based stress management programs can improve mental health among workers. However, such mental health programs have scarcely been implemented in micro– and small-sized enterprises (MSEs), which are lacking in occupational healthcare services. 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 pre-post design feasibility study will be conducted on ten companies to evaluate trial methods (e.g., recruitment, penetration, 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 specifies that more than 50% of the recruited companies obtain 60% individual penetration. Finally, acceptability, appropriateness, feasibility, and cost will be measured using quantitative internet-based questionnaires and qualitative 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 (registration date: February 21, 2022) Contributions to the literature ### Competing Interest Statement NS reports personal fees from Medilio Inc., outside the submitted work. KI is employed at the Department of Digital Mental Health, an endowment department supported with an unrestricted grant from 15 enterprises (), outside the submitted work. Others declared no competing interests related to this work. ### Clinical Trial UMIN000046960 ### Funding Statement This work was supported by a work-related diseases clinical research grant. 2020 (200401-01) and JSPS KAKENHI Grant Number JP22K03168. Sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study protocol was approved by the Research Ethics Committee of the Graduate School of Medicine, Faculty of Medicine, University of Tokyo (2021190NI-(1)) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data related to the present study protocol are available from the corresponding author, KI, upon reasonable request. * BJSQ : Brief Job Stress Questionnaire MSEs : Micro-, or small-sized enterprises MSMEs : Micro-, small-, or medium-sized enterprises PPI : Patient and Public Involvement