ABSTRACT

This document gives a statistical analysis plan of the acute intervention effects of the RESiLIENT (Resilience Enhancement with Smartphone in LIving ENvironmenTs) trial, designed as a master protocol including four 2×2 factorial trials to elucidate specific efficacies of five cognitive-behavioural therapy (CBT) skills (cognitive restructuring, behavioural activation, problem-solving, assertion training, and behavior therapy for insomnia) using the internet CBT program. This trial was registered within the UMIN Clinical Trials Registry in Japan (UMIN000047124). The study protocol has previously been published (BMJ Open 2023;13:e067850).

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

UMIN000047124

Clinical Protocols

https://bmjopen.bmj.com/content/13/2/e067850

Funding Statement

This study is funded by the Japan Agency for Medical Research and Development (AMED) (grant number JP22de0107005).

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 trial has been approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1556).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the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

Footnotes

Principal Investigator: Toshi A. Furukawa, M.D., Ph.D. Professor Departments of Health Promotion and Human Behavior Kyoto University Graduate School of Medicine / School of Public Health Yoshida Konoe-cho, Sakyo-ku Kyoto 606-8501, Japan Phone: +81-75-753-9491 Email: furukawakuhp.kyoto-u.ac.jp

Trial Statistician: Hisashi Noma, Ph.D. Professor Department of Interdisciplinary Statistical Mathematics The Institute of Statistical Mathematics 10-3, Midori-cho, Tachikawa Tokyo 190-8562, JAPAN Phone: +81-50-5533-8440 Email: nomaism.ac.jp

Data Availability

This is a statistical analysis plan document and does not involve new data.

ABBREVIATIONS AND DEFINITIONSCBTcognitive-behavioral therapyCRcognitive restructuringBAbehavioural activationPSproblem-solvingATassertion trainingBIbehavior therapy for insomniaPHQ-9Patient Health Questionnaire-9GAD-7Generalized Anxiety Disorder-7ISIInsomnia Severity IndexSWEMWBSShort Warwick Edinburgh Mental Well-Being ScaleWSASWork and Social Adjustment ScaleUWESUtrecht Work Engagement ScaleHPQHealth and Work Performance QuestionnaireEQ-5D-5LEuroQOL-5D-5LCAQ-3Client Satisfaction Questionnaire-3FASfull analysis setMMRMmixed-effects models for repeated measures