Academic Journal
View in EDS
HTML Full Text

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

Bibliographic Details
Title: 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
Authors: Uchida, Megumi, Furukawa, Toshiaki A, Yamaguchi, Takuhiro, Imai, Fuminobu, Momino, Kanae, Katsuki, Fujika, Sakurai, Naomi, Miyaji, Tempei, Horikoshi, Masaru, Iwata, Hiroji, Zenda, Sadamoto, Iwatani, Tsuguo, Ogawa, Asao, Inoue, Akira, Abe, Masakazu, Toyama, Tatsuya, Uchitomi, Yosuke, Matsuoka, Hiromichi, Noma, Hisashi, Akechi, Tatsuo
Source: Trials; 5/22/2023, Vol. 24 Issue 1, p1-13, 13p
Subject Terms: PSYCHOTHERAPY, MENTAL health personnel, PROBLEM-solving therapy, RANDOMIZED controlled trials, COGNITIVE therapy, CLINICS, MATH anxiety
Abstract: Background: Cancer 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. Methods: Based 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. Discussion: The 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 registration: UMIN000041536, CTR. Registered on 1 November 2020 https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047301. [ABSTRACT FROM AUTHOR]
Copyright of Trials is the property of BioMed Central and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Complementary Index
Full text is not displayed to guests.
FullText Links:
  – Type: pdflink
Text:
  Availability: 1
CustomLinks:
  – Url: https://resolver.ebsco.com/c/xy5jbn/result?sid=EBSCO:edb&genre=article&issn=17456215&ISBN=&volume=24&issue=1&date=20230522&spage=1&pages=1-13&title=Trials&atitle=Optimization%20of%20smartphone%20psychotherapy%20for%20depression%20and%20anxiety%20among%20patients%20with%20cancer%20using%20the%20multiphase%20optimization%20strategy%20%28MOST%29%20framework%20and%20decentralized%20clinical%20trial%20system%20%28SMartphone%20Intervention%20to%20LEssen%20depression%2FAnxiety%20and%20GAIN%20resilience%3A%20SMILE%20AGAIN%20project%29%3A%20a%20protocol%20for%20a%20randomized%20controlled%20trial&aulast=Uchida%2C%20Megumi&id=DOI:10.1186/s13063-023-07307-y
    Name: Full Text Finder (for New FTF UI) (s8985755)
    Category: fullText
    Text: Find It @ SCU Libraries
    MouseOverText: Find It @ SCU Libraries
Header DbId: edb
DbLabel: Complementary Index
An: 163850344
RelevancyScore: 973
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 973.294494628906
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: 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
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Uchida%2C+Megumi%22">Uchida, Megumi</searchLink><br /><searchLink fieldCode="AR" term="%22Furukawa%2C+Toshiaki+A%22">Furukawa, Toshiaki A</searchLink><br /><searchLink fieldCode="AR" term="%22Yamaguchi%2C+Takuhiro%22">Yamaguchi, Takuhiro</searchLink><br /><searchLink fieldCode="AR" term="%22Imai%2C+Fuminobu%22">Imai, Fuminobu</searchLink><br /><searchLink fieldCode="AR" term="%22Momino%2C+Kanae%22">Momino, Kanae</searchLink><br /><searchLink fieldCode="AR" term="%22Katsuki%2C+Fujika%22">Katsuki, Fujika</searchLink><br /><searchLink fieldCode="AR" term="%22Sakurai%2C+Naomi%22">Sakurai, Naomi</searchLink><br /><searchLink fieldCode="AR" term="%22Miyaji%2C+Tempei%22">Miyaji, Tempei</searchLink><br /><searchLink fieldCode="AR" term="%22Horikoshi%2C+Masaru%22">Horikoshi, Masaru</searchLink><br /><searchLink fieldCode="AR" term="%22Iwata%2C+Hiroji%22">Iwata, Hiroji</searchLink><br /><searchLink fieldCode="AR" term="%22Zenda%2C+Sadamoto%22">Zenda, Sadamoto</searchLink><br /><searchLink fieldCode="AR" term="%22Iwatani%2C+Tsuguo%22">Iwatani, Tsuguo</searchLink><br /><searchLink fieldCode="AR" term="%22Ogawa%2C+Asao%22">Ogawa, Asao</searchLink><br /><searchLink fieldCode="AR" term="%22Inoue%2C+Akira%22">Inoue, Akira</searchLink><br /><searchLink fieldCode="AR" term="%22Abe%2C+Masakazu%22">Abe, Masakazu</searchLink><br /><searchLink fieldCode="AR" term="%22Toyama%2C+Tatsuya%22">Toyama, Tatsuya</searchLink><br /><searchLink fieldCode="AR" term="%22Uchitomi%2C+Yosuke%22">Uchitomi, Yosuke</searchLink><br /><searchLink fieldCode="AR" term="%22Matsuoka%2C+Hiromichi%22">Matsuoka, Hiromichi</searchLink><br /><searchLink fieldCode="AR" term="%22Noma%2C+Hisashi%22">Noma, Hisashi</searchLink><br /><searchLink fieldCode="AR" term="%22Akechi%2C+Tatsuo%22">Akechi, Tatsuo</searchLink>
– Name: TitleSource
  Label: Source
  Group: Src
  Data: Trials; 5/22/2023, Vol. 24 Issue 1, p1-13, 13p
– Name: Subject
  Label: Subject Terms
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22PSYCHOTHERAPY%22">PSYCHOTHERAPY</searchLink><br /><searchLink fieldCode="DE" term="%22MENTAL+health+personnel%22">MENTAL health personnel</searchLink><br /><searchLink fieldCode="DE" term="%22PROBLEM-solving+therapy%22">PROBLEM-solving therapy</searchLink><br /><searchLink fieldCode="DE" term="%22RANDOMIZED+controlled+trials%22">RANDOMIZED controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22COGNITIVE+therapy%22">COGNITIVE therapy</searchLink><br /><searchLink fieldCode="DE" term="%22CLINICS%22">CLINICS</searchLink><br /><searchLink fieldCode="DE" term="%22MATH+anxiety%22">MATH anxiety</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Background: Cancer 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. Methods: Based 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. Discussion: The 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 registration: UMIN000041536, CTR. Registered on 1 November 2020 https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047301. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label:
  Group: Ab
  Data: <i>Copyright of Trials is the property of BioMed Central and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://login.libproxy.scu.edu/login?url=https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&scope=site&db=edb&AN=163850344
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1186/s13063-023-07307-y
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 13
        StartPage: 1
    Subjects:
      – SubjectFull: PSYCHOTHERAPY
        Type: general
      – SubjectFull: MENTAL health personnel
        Type: general
      – SubjectFull: PROBLEM-solving therapy
        Type: general
      – SubjectFull: RANDOMIZED controlled trials
        Type: general
      – SubjectFull: COGNITIVE therapy
        Type: general
      – SubjectFull: CLINICS
        Type: general
      – SubjectFull: MATH anxiety
        Type: general
    Titles:
      – TitleFull: 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
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Uchida, Megumi
      – PersonEntity:
          Name:
            NameFull: Furukawa, Toshiaki A
      – PersonEntity:
          Name:
            NameFull: Yamaguchi, Takuhiro
      – PersonEntity:
          Name:
            NameFull: Imai, Fuminobu
      – PersonEntity:
          Name:
            NameFull: Momino, Kanae
      – PersonEntity:
          Name:
            NameFull: Katsuki, Fujika
      – PersonEntity:
          Name:
            NameFull: Sakurai, Naomi
      – PersonEntity:
          Name:
            NameFull: Miyaji, Tempei
      – PersonEntity:
          Name:
            NameFull: Horikoshi, Masaru
      – PersonEntity:
          Name:
            NameFull: Iwata, Hiroji
      – PersonEntity:
          Name:
            NameFull: Zenda, Sadamoto
      – PersonEntity:
          Name:
            NameFull: Iwatani, Tsuguo
      – PersonEntity:
          Name:
            NameFull: Ogawa, Asao
      – PersonEntity:
          Name:
            NameFull: Inoue, Akira
      – PersonEntity:
          Name:
            NameFull: Abe, Masakazu
      – PersonEntity:
          Name:
            NameFull: Toyama, Tatsuya
      – PersonEntity:
          Name:
            NameFull: Uchitomi, Yosuke
      – PersonEntity:
          Name:
            NameFull: Matsuoka, Hiromichi
      – PersonEntity:
          Name:
            NameFull: Noma, Hisashi
      – PersonEntity:
          Name:
            NameFull: Akechi, Tatsuo
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 22
              M: 05
              Text: 5/22/2023
              Type: published
              Y: 2023
          Identifiers:
            – Type: issn-print
              Value: 17456215
          Numbering:
            – Type: volume
              Value: 24
            – Type: issue
              Value: 1
          Titles:
            – TitleFull: Trials
              Type: main
ResultId 1