Healthy Campus Trial

A multiphase optimization strategy (MOST) fully factorial trial to optimize the smartphone cognitive behavioral therapy (CBT) app for mental health promotion among university students: Study protocol for a randomized controlled trial

Teruhisa Uwatoko, Yan Luo, Masatsugu Sakata, Daisuke Kobayashi, Yu Sakagami, Kazumi Takemoto, Linda Marie Collins, Ed Watkins, Steven D. Hollon, James Wason, Hisashi Noma, Masaru Horikoshi, Takashi Kawamura, Taku Iwami, Toshi A. Furukawa

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Youth in general and college life in particular are characterized by new educational, vocational, and interpersonal challenges, opportunities, and substantial stress. It is estimated that 30-50% of university students meet criteria for some mental disorder, especially depression, in any given year. The university has traditionally provided many channels to promote students' mental health, but until now only a minority have sought such help, possibly owing to lack of time and/or to stigma related to mental illness. Smartphone-delivered cognitive behavioral therapy (CBT) shows promise for its accessibility and effectiveness. However, its most effective components and for whom it is more (or less) effective are not known. Methods/design: Based on the multiphase optimization strategy framework, this study is a parallel-group, multicenter, open, fully factorial trial examining five smartphone-delivered CBT components (self-monitoring, cognitive restructuring, behavioral activation, assertion training, and problem solving) among university students with elevated distress, defined as scoring 5 or more on the Patient Health Questionnaire-9 (PHQ-9). The primary outcome is change in PHQ-9 scores from baseline to week 8. We will estimate specific efficacy of the five components and their interactions through the mixed-effects repeated-measures analysis and propose the most effective and efficacious combinations of components. Effect modification by selected baseline characteristics will be examined in exploratory analyses. Discussion: The highly efficient experimental design will allow identification of the most effective components and the most efficient combinations thereof among the five components of smartphone CBT for university students. Pragmatically, the findings will help make the most efficacious CBT package accessible to a large number of distressed university students at reduced cost; theoretically, they will shed light on the underlying mechanisms of CBT and help further advance CBT for depression.

Original languageEnglish (US)
Article number353
JournalTrials
Volume19
Issue number1
DOIs
StatePublished - Jul 4 2018

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Cognitive Therapy
Health Promotion
Mental Health
Randomized Controlled Trials
Students
Depression
Health
Mental Disorders
Smartphone
Research Design
Costs and Cost Analysis

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Uwatoko, Teruhisa ; Luo, Yan ; Sakata, Masatsugu ; Kobayashi, Daisuke ; Sakagami, Yu ; Takemoto, Kazumi ; Collins, Linda Marie ; Watkins, Ed ; Hollon, Steven D. ; Wason, James ; Noma, Hisashi ; Horikoshi, Masaru ; Kawamura, Takashi ; Iwami, Taku ; Furukawa, Toshi A. / Healthy Campus Trial : A multiphase optimization strategy (MOST) fully factorial trial to optimize the smartphone cognitive behavioral therapy (CBT) app for mental health promotion among university students: Study protocol for a randomized controlled trial. In: Trials. 2018 ; Vol. 19, No. 1.
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abstract = "Background: Youth in general and college life in particular are characterized by new educational, vocational, and interpersonal challenges, opportunities, and substantial stress. It is estimated that 30-50{\%} of university students meet criteria for some mental disorder, especially depression, in any given year. The university has traditionally provided many channels to promote students' mental health, but until now only a minority have sought such help, possibly owing to lack of time and/or to stigma related to mental illness. Smartphone-delivered cognitive behavioral therapy (CBT) shows promise for its accessibility and effectiveness. However, its most effective components and for whom it is more (or less) effective are not known. Methods/design: Based on the multiphase optimization strategy framework, this study is a parallel-group, multicenter, open, fully factorial trial examining five smartphone-delivered CBT components (self-monitoring, cognitive restructuring, behavioral activation, assertion training, and problem solving) among university students with elevated distress, defined as scoring 5 or more on the Patient Health Questionnaire-9 (PHQ-9). The primary outcome is change in PHQ-9 scores from baseline to week 8. We will estimate specific efficacy of the five components and their interactions through the mixed-effects repeated-measures analysis and propose the most effective and efficacious combinations of components. Effect modification by selected baseline characteristics will be examined in exploratory analyses. Discussion: The highly efficient experimental design will allow identification of the most effective components and the most efficient combinations thereof among the five components of smartphone CBT for university students. Pragmatically, the findings will help make the most efficacious CBT package accessible to a large number of distressed university students at reduced cost; theoretically, they will shed light on the underlying mechanisms of CBT and help further advance CBT for depression.",
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Healthy Campus Trial : A multiphase optimization strategy (MOST) fully factorial trial to optimize the smartphone cognitive behavioral therapy (CBT) app for mental health promotion among university students: Study protocol for a randomized controlled trial. / Uwatoko, Teruhisa; Luo, Yan; Sakata, Masatsugu; Kobayashi, Daisuke; Sakagami, Yu; Takemoto, Kazumi; Collins, Linda Marie; Watkins, Ed; Hollon, Steven D.; Wason, James; Noma, Hisashi; Horikoshi, Masaru; Kawamura, Takashi; Iwami, Taku; Furukawa, Toshi A.

In: Trials, Vol. 19, No. 1, 353, 04.07.2018.

Research output: Contribution to journalArticle

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T2 - A multiphase optimization strategy (MOST) fully factorial trial to optimize the smartphone cognitive behavioral therapy (CBT) app for mental health promotion among university students: Study protocol for a randomized controlled trial

AU - Uwatoko, Teruhisa

AU - Luo, Yan

AU - Sakata, Masatsugu

AU - Kobayashi, Daisuke

AU - Sakagami, Yu

AU - Takemoto, Kazumi

AU - Collins, Linda Marie

AU - Watkins, Ed

AU - Hollon, Steven D.

AU - Wason, James

AU - Noma, Hisashi

AU - Horikoshi, Masaru

AU - Kawamura, Takashi

AU - Iwami, Taku

AU - Furukawa, Toshi A.

PY - 2018/7/4

Y1 - 2018/7/4

N2 - Background: Youth in general and college life in particular are characterized by new educational, vocational, and interpersonal challenges, opportunities, and substantial stress. It is estimated that 30-50% of university students meet criteria for some mental disorder, especially depression, in any given year. The university has traditionally provided many channels to promote students' mental health, but until now only a minority have sought such help, possibly owing to lack of time and/or to stigma related to mental illness. Smartphone-delivered cognitive behavioral therapy (CBT) shows promise for its accessibility and effectiveness. However, its most effective components and for whom it is more (or less) effective are not known. Methods/design: Based on the multiphase optimization strategy framework, this study is a parallel-group, multicenter, open, fully factorial trial examining five smartphone-delivered CBT components (self-monitoring, cognitive restructuring, behavioral activation, assertion training, and problem solving) among university students with elevated distress, defined as scoring 5 or more on the Patient Health Questionnaire-9 (PHQ-9). The primary outcome is change in PHQ-9 scores from baseline to week 8. We will estimate specific efficacy of the five components and their interactions through the mixed-effects repeated-measures analysis and propose the most effective and efficacious combinations of components. Effect modification by selected baseline characteristics will be examined in exploratory analyses. Discussion: The highly efficient experimental design will allow identification of the most effective components and the most efficient combinations thereof among the five components of smartphone CBT for university students. Pragmatically, the findings will help make the most efficacious CBT package accessible to a large number of distressed university students at reduced cost; theoretically, they will shed light on the underlying mechanisms of CBT and help further advance CBT for depression.

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