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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

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

Published in: Trials | Issue 1/2018

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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.

Trial registration

UMIN, CTR-000031307. Registered on February 14, 2018.
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Metadata
Title
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
Authors
Teruhisa Uwatoko
Yan Luo
Masatsugu Sakata
Daisuke Kobayashi
Yu Sakagami
Kazumi Takemoto
Linda M. Collins
Ed Watkins
Steven D. Hollon
James Wason
Hisashi Noma
Masaru Horikoshi
Takashi Kawamura
Taku Iwami
Toshi A. Furukawa
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2719-z

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