UMIN-CTR Clinical Trial

Public title

health promotion among university students: a fully factorial randomized study

Acronym

Healthy Campus Trial

Scientific Title

health promotion among university students: a fully factorial randomized study

Scientific Title:Acronym

Healthy Campus Trial

Region

Japan

Condition

Graduate and undergraduate students in Japanese universities

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To conduct a fully factorial trial involving five components of cognitive-behavior therapy (self-monitoring, cognitive restructuring, behavioral activation, assertion, problem solving) with 1088 university students to estimate their specific efficacy of each component and to develop the most effective and efficient CBT package.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcome of Analysis 1 is self-administered Personal Health Questinnaire-9 (PHQ-9) at week 8.
The primary outcome of Analysis 2 is incidence of a major depressive episode as assessed by the major depressive episode section of the computerised Composite International Diagnostic Interview (CIDI) at week 52.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

2^5*2=64 combinations of five components of smartphone CBT, with randomized sequence between cognitive restructuring and behavioral activation
Each component will consist of one lesson, which normally takes 7-10 days.
In the factorial design, each component will be compared among those combinations with or without that component.

Interventions/Control_2

2^5*2=64 combinations of five components of smartphone CBT, with randomized sequence between cognitive restructuring and behavioral activation

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

40

years-old

>

Gender

Male and Female

Key inclusion criteria

1. University students enrolled in full-time undergraduate or graduate programs at the participating
universities
a. Aged between 18 and 39 at time of enrollment. The upper age limit of 39 was adopted in order
to secure homogeneity of the participants within
adolescence to young adulthood.
b. Of either sex
2. They must have their own smartphone, either an Apple iPhone or Android device.
3. They must provide written informed consent to participate in this study after full disclosure of the contents and procedures of the study.
4. They must have completed the PE component
within 2 weeks after providing their consent.

Key exclusion criteria

1. Being unable to understand written Japanese
2. Currently receiving professional treatment for
mental health problems
3. Scoring 15 or more on PHQ-9, or scoring 10 or more on PHQ-9 and scoring 2 or 3 on item 9 of PHQ-9 at screening

Target sample size

1088

Name of lead principal investigator

1st name	Toshi
Middle name	A.
Last name	Furukawa

Organization

Kyoto University Graduate School of Medicine / School of Public Health

Division name

Department of Health Promotion and Human Behavior

Zip code

606-8501

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

TEL

075-753-9491

Email

furukawa@kuhp.kyoto-u.ac.jp

Name of contact person

1st name	Teruhisa
Middle name
Last name	Uwatoko

Organization

Kyoto University

Division name

Health Sciences Center

Zip code

606-8501

Address

Yoshida, Sakyo-ku, Kyoto

TEL

075-753-2426

Homepage URL

Email

uwatoko.teruhisa.8s@kyoto-u.ac.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Kyoto University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

02

Month

14

Day

URL releasing protocol

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2719-z

Publication of results

Published

URL related to results and publications

http://dx.doi.org/10.1136/ebmental-2022-300455

Number of participants that the trial has enrolled

1093

Results

92% of the participants had access to the primary outcome. Depression was significantly reduced for all participants through 8 weeks, with pre post effect sizes ranging between -0.65 and -0.78 at week 8. However, the presence of any of the components did not significantly enhance depression reduction, with between group effect size point estimates ranging between -0.04 and 0.03. Second order interactions between the components also showed no noteworthy effects.

Results date posted

2024

Year

03

Month

18

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

We finally included 1093 participants in the current analyses. Participants had a mean age of 21.6 (SD=3.03), 58% were women, and 76% were undergraduates.

Participant flow

Our smartphone app, Resilience Training, included six iCBT components of PE, SM, BA, CR, AT, and PS. While PE was a constant component provided to all participants, SM, BA, CR, AT, and PS were experimental components for comparing their presence and absence. All participants first received the PE lesson that provided psychoeducation about stress and the CBT model and emphasized the importance of self-checks through weekly PHQ-9 assessments.
After PE, the app system randomly assigned each participant to one of the 2^5=32 combinations corresponding with the presence or absence of SM, BA, CR, AT, or PS. Each component consisted of a psychoeducational lesson explaining the rationale and steps for each cognitive or behavioral skill and homework sheets to practice the learned skill. Each lesson was supposed to take one week to complete.
Intervention periods were eight weeks, and participants answered the PHQ-9 every week.

Adverse events

None of the participants presented with serious adverse events.

Outcome measures

The primary outcome was the change score of the PHQ-9 at week 8
The secondary outcomes were the change score of the GAD-7, CBT Skills Scale, and presenteeism.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2018

Year

02

Month

14

Day

Date of IRB

2018

Year

02

Month

14

Day

Anticipated trial start date

2018

Year

04

Month

01

Day

Last follow-up date

2022

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Sakata M, Toyomoto R, Yoshida K, Luo Y, Nakagami Y, Uwatoko T, Shimamoto T, Tajika A, Suga H, Ito H, Sumi M, Muto T, Ito M, Ichikawa H, Ikegawa M, Shiraishi N, Watanabe T, Sahker E, Ogawa Y, Hollon SD, Collins LM, Watkins ER, Wason J, Noma H, Horikoshi M, Iwami T & Furukawa TA (2022) Components of smartphone cognitive-behavioural therapy for subthreshold depression among 1093 university students: A factorial trial. Evidence-Based Mental Health.

Registered date

2018

Year

02

Month

14

Day

Last modified on

2024

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035735