Optimization of smartphone psychotherapy for depression and anxiety among patients with cancer using the multiphase optimization strategy (MOST) framework and decentralized clinical trial system (SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience: SMILE AGAIN project): a protocol for a randomized controlled trial

Trials

Study Protocol

Yosuke Uchitomi¹  Naomi Sakurai²  Hiroji Iwata³  Tatsuya Toyama⁴  Tsuguo Iwatani⁵  Tempei Miyaji⁶  Toshiaki A Furukawa⁷  Kanae Momino⁸  Akira Inoue⁹  Fujika Katsuki^1,10  Fuminobu Imai^1,11  Tatsuo Akechi^1,12  Megumi Uchida^1,12  Asao Ogawa^1,13  Hiromichi Matsuoka^1,14  Takuhiro Yamaguchi^1,15  Masakazu Abe^1,16  Sadamoto Zenda^1,17  Hisashi Noma^1,18  Masaru Horikoshi^1,19 

[1] Behavioral and Survivorship Research Group, Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Tokyo, Japan;Center for Public Health Sciences, National Cancer Center, Tokyo, Japan;Cancer Solutions, Tokyo, Japan;Department of Breast Oncology, Aichi Cancer Center, Nagoya, Japan;Department of Breast Surgery, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan;Department of Breast Surgery, National Cancer Center Hospital East, Chiba, Japan;Department of Clinical Trial Data Management, Tokyo University Graduate School of Medicine, Tokyo, Japan;Department of Health Promotion and Human Behavior, Graduate School of Medicine/School of Public Health, Kyoto University, Kyoto, Japan;Department of Nursing Administration and Management, Nagoya City University Graduate School of Nursing, Nagoya, Japan;Department of Palliative Medicine, Tohoku University School of Medicine, Miyagi, Japan;Department of Psychiatric and Mental Health Nursing, Nagoya City University Graduate School of Nursing, Nagoya, Japan;Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, 467-8601, Nagoya, Aichi, Japan;Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, 467-8601, Nagoya, Aichi, Japan;Center for Palliative Care and Psycho-oncology, Nagoya City University Hospital, Nagoya, Japan;Department of Psycho-Oncology Service, National Cancer Center Hospital East, Kashiwa, Japan;Department of Psycho-Oncology, National Cancer Center Hospital, Tokyo, Japan;Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan;Division of Gynecologic Oncology, Shizuoka Cancer Center, Shizuoka, Japan;Department of Gynecology, Hamamatsu University School of Medicine, Shizuoka, Japan;Division of Radiation Oncology, National Cancer Center Hospital East, Chiba, Japan;Institute of Statistical Mathematics, Tokyo, Japan;National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry, Tokyo, Japan;

关键词: Smartphone psychotherapy;    Depression;    Anxiety;    Cancer;    Behavioral activation;    Assertion training;    Problem-solving therapy;    Psychoeducation;   

DOI  :  10.1186/s13063-023-07307-y

 received in 2022-03-15, accepted in 2023-04-11,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundCancer patients experience various forms of psychological distress. Their distress, mainly in the form of depression and anxiety, leads to poor quality of life, increased medical spending due to frequent visits, and decrease in treatment adherence. It is estimated that 30–50% among them would require support from mental health professionals: in reality, much less actually receive such support partly due to a shortage of qualified professionals and also due to psychological barriers in seeking such help. The purpose of the present study is to develop the easily accessible and the most efficient and effective smartphone psychotherapy package to alleviate depression and anxiety in cancer patients.MethodsBased on the multiphase optimization strategy (MOST) framework, the SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience project (SMILE-AGAIN project) is a parallel-group, multicenter, open, stratified block randomized, fully factorial trial with four experimental components: psychosocial education (PE), behavioral activation (BA), assertion training (AT), and problem-solving therapy (PS). The allocation sequences are maintained centrally. All participants receive PE and then are randomized to the presence/absence of the remaining three components. The primary outcome of this study is the Patient Health Questionnaire-9 (PHQ-9) total score, which will be administered as an electronic patient-reported outcome on the patients’ smartphones after 8 weeks. The protocol was approved by the Institutional Review Board of Nagoya City University on July 15, 2020 (ID: 46-20-0005). The randomized trial, which commenced in March 2021, is currently enrolling participants. The estimated end date for this study is March 2023.DiscussionThe highly efficient experimental design will allow for the identification of the most effective components and the most efficient combinations among the four components of the smartphone psychotherapy package for cancer patients. Given that many cancer patients face significant psychological hurdles in seeing mental health professionals, easily accessible therapeutic interventions without hospital visits may offer benefits. If an effective combination of psychotherapy is determined in this study, it can be provided using smartphones to patients who cannot easily access hospitals or clinics.Trial registrationUMIN000041536, CTR. Registered on 1 November 2020 https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047301.

【 授权许可】

CC BY   
© The Author(s) 2023

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