Evidence map›Paper›PMID 38581058›Full record

ArticlePilot and feasibility studies2024

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.

Natsu Sasaki, Taichi Shimazu, Hajime Takeno, Sayaka Ogawa, Utako Sawada, Akizumi Tsutsumi, Kotaro Imamura

Abstract read
In one paragraph

Article in Pilot and feasibility studies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Natsu SasakiDepartment of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Taichi ShimazuDivision of Behavioral Sciences, National Cancer Center Institute for Cancer Control, National Cancer Center, Tokyo, Japan.
Hajime TakenoDepartment of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Sayaka OgawaDepartment of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Utako SawadaDepartment of Psychiatric Nursing, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Akizumi TsutsumiDepartment of Public Health, Kitasato University School of Medicine, Sagamihara, Japan.
Kotaro ImamuraDepartment of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. kouima-tky@umin.ac.jp.ORCID http://orcid.org/0000-0003-2584-0666

Funding

JSPS KAKENHI Grant JP22K03168work-related diseases clinical research grant 200401-01
6 · The paper itself

Abstract

backgroundAlthough 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.

objectivesThis 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.

methodsFor 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.

conclusionsThis 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 registrationUMIN clinical trial registration, UMIN000046960. Registered on February 21, 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053570.

Indexed as

Health equityImplementation scienceInternet-based interventionMixed-methodsOccupational healthStress prevention

Identifiers

PMID38581058
PMCPMC10996202

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.