Cultural Adaptation of the Actionable Health App Evaluation in Japan: Protocol for a Web-Based Modified Delphi Expert Consensus Study

BackgroundWith an increase in both the number of mental health disorders people are experiencing and the difficulty in accessing mental health care, the demand for accessible mental health care services has increased. The use of mobile devices has allowed people to receive care in their daily lives without restrictions on time or location. However, the majority of publicly available mobile health apps are not evidence-based, and the top-rated apps are not always safe or user-friendly and may not offer clinically beneficial results. ObjectiveThis study aims to create a cultural adaptation of the American Psychiatric Association’s comprehensive app evaluation framework in Japan using a web-based modified Delphi expert consensus. MethodsA web-based modified Delphi study includes developing the Japanese version of the comprehensive app evaluation framework and 3 Delphi rounds. In the first round, our working group sends a questionnaire to the panelists, who then complete it. In the second and third rounds, the working group sends a questionnaire and a summary of the panelists’ answers based on each of the previous rounds. The panelists answer the questionnaires based on this summary. The summarization procedure is automated to help reduce the biases that can be generated when panelists’ answers are summarized and when the panelists receive them. The working group sends only the result of the summarization with the next round’s questionnaire. All interactions between the working group and the panelists will be conducted on Qualtrics (Qualtrics Japan LLC), a questionnaire platform. To culturally validate the comprehensive mental health app evaluation framework, participants from the following three categories will be recruited in Japan: (1) researchers, (2) practitioners, and (3) app developers. ResultsThis study received funding from a crowdfunding campaign in Japan (April 2023). The Delphi study began in January 2023 and will be completed in December 2023. We had already completed the translation of the 105 original app evaluation item questions by December 2022. ConclusionsWhile the need for treatment using mental health apps is increasing, no framework that can be used to develop a centralized database for health apps is available or accessible, and no consensus has been reached among stakeholders in Japan about an appropriate framework. The results of the web-based modified Delphi method presented in this paper may provide direction for the development and use of mental health apps in the future among the relevant stakeholders. Furthermore, this study will enhance recognition of the framework among researchers, clinicians, mental health app developers, and users, in addition to devising new instruments to help users or practitioners efficiently choose the right app for their situations. International Registered Report Identifier (IRRID)PRR1-10.2196/4446

Randomised controlled trial of cultural-adapted and programme-adopted cognitive behavioural therapy for children and adolescents’ anxiety in Japan: protocol for a Multi-, Inter-, and Cross-cultural Clinical Child Study (MIXCS)

Introduction The primary objective of the Multi-, Inter-, and Cross-cultural Clinical Child Study (MIXCS) is to evaluate the hypothesis that the effects of cultural-adapted cognitive behavioural therapy (CA-CBT) and programme-adopted cognitive behavioural therapy (PA-CBT) for children and adolescents’ anxiety are both superior to a psychological control (moral education control: MEC) for reducing child and adolescent anxiety disorders and symptoms as well as related constructs. The secondary objective is to explore commonalities and differences in therapy factors between CA-CBT and PA-CBT.Method and analysis The study has been designed as a randomised, controlled and assessor masked multicentre superiority trial with three groups: CA-CBT, PA-CBT and MEC. Primary outcome is remission of primary anxiety disorders evaluated by independent evaluators. Secondary outcomes are clinician’s severity ratings, child self-reported anxiety symptoms, depressive symptoms, cognitive errors and family accommodation, as well as parent-reported anxiety symptoms, and family accommodation. Competence and adherence of treatment, therapy factors in treatment sessions are also measured based on behavioural observation. Finally, satisfaction and comprehension are collected. We aim to recruit at least 99 families for the analysis. Treatment will be delivered weekly for 10 sessions and assessment will be conducted 2 weeks before the treatment (pre), 3 months after the base date when the treatment starts (post), 6 months (six months follow-up) and 12 months (12 months follow-up) after the postassessment.Ethics and dissemination The MIXCS study was approved by Doshisha University Research Ethics Review Committee, Kwansei Gakuin University Institutional Review Board for Medical and Biological Research Involving Human Subjects and Shinshu University Certified Review Board of Clinical Research. Regardless of the results, the primary outcome will be published in a journal, and if the efficacy and effectiveness of CA-CBT and/or PA-CBT are empirically supported, the authors will encourage dissemination of the programmes including the assessment system through key stakeholders in education, health, and welfare areas.Trial registration number UMIN00003812