Four 2×2 factorial trials of smartphone CBT to reduce subthreshold depression and to prevent new depressive episodes among adults in the community–RESiLIENT trial (Resilience Enhancement with Smartphone in LIving ENvironmenTs): a master protocol
Toshi A Furukawa,
Pim Cuijpers,
Tatsuo Akechi,
Masaru Horikoshi,
Yan Luo,
Hisashi Noma,
Takeo Nakayama,
Helen Christensen,
Naoki Kondo,
Norito Kawakami,
Aran Tajika,
Ronald C Kessler,
Shingo Fukuma,
Masatsugu Sakata,
Rie Toyomoto,
James M S Wason
Affiliations
Toshi A Furukawa
Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan
Pim Cuijpers
3 Department of Clinical, Neuro and Developmental Psychology, WHO Collaborating Centre for Research and Dissemination of Psychological Interventions, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
Tatsuo Akechi
Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Masaru Horikoshi
National Center of Neurology and Psychiatry, Tokyo, Japan
Yan Luo
Shenzhen Pingshan District Center for Disease Control and Prevention, Shenzhen, Guangdong, China
Hisashi Noma
4 Department of Data Science, The Institute of Statistical Mathematics, Tachikawa, Japan
Takeo Nakayama
Department of Health Informatics, Kyoto University School of Public Health, Kyoto, Japan
Helen Christensen
1 Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia
Naoki Kondo
Department of Social Epidemiology, Kyoto University Graduate School of Medicine, Kyoto, Kyoto, Japan
Norito Kawakami
3 Department of Digital Mental Health, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
Aran Tajika
Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine / School of Public Health, Kyoto, Japan
Ronald C Kessler
3 Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA
Shingo Fukuma
Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan
Masatsugu Sakata
Departments of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine Faculty of Medicine, Kyoto, Japan
Rie Toyomoto
Departments of Health Promotion and Human Behavior and Clinical Epidemiology, Kyoto University Graduate School of Medicine / School of Public Health, Kyoto, Japan
James M S Wason
Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
Introduction The health burden due to depression is ever increasing in the world. Prevention is a key to reducing this burden. Guided internet cognitive–behavioural therapies (iCBT) appear promising but there is room for improvement because we do not yet know which of various iCBT skills are more efficacious than others, and for whom. In addition, there has been no platform for iCBT that can accommodate ongoing evolution of internet technologies.Methods and analysis Based on our decade-long experiences in developing smartphone CBT apps and examining them in randomised controlled trials, we have developed the Resilience Training App Version 2. This app now covers five CBT skills: cognitive restructuring, behavioural activation, problem-solving, assertion training and behaviour therapy for insomnia. The current study is designed as a master protocol including four 2×2 factorial trials using this app (1) to elucidate specific efficacies of each CBT skill, (2) to identify participants’ characteristics that enable matching between skills and individuals, and (3) to allow future inclusion of new skills. We will recruit 3520 participants with subthreshold depression and ca 1700 participants without subthreshold depression, to examine the short-term efficacies of CBT skills to reduce depressive symptoms in the former and to explore the long-term efficacies in preventing depression in the total sample. The primary outcome for the short-term efficacies is the change in depressive symptoms as measured with the Patient Health Questionnaire-9 at week 6, and that for the long-term efficacies is the incidence of major depressive episodes as assessed by the computerised Composite International Diagnostic Interview by week 50.Ethics and dissemination The trial has been approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1556).Trial registration number UMIN000047124.
