UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000040332
Receipt No. R000046021
Scientific Title Development and experimental study of mental health app for university students.
Date of disclosure of the study information 2020/05/13
Last modified on 2020/11/07 (Ver. 5)

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Basic information
Public title Development of mental health app for university students.
Acronym Development of mental health app for university students.
Scientific Title Development and experimental study of mental health app for university students.
Scientific Title:Acronym Development and experimental study of mental health app for university students.
Region
Japan

Condition
Condition Mental disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We developed a smartphone application (Mental App) for the university students and examined the effects of the app on their mental health.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in the results of psychological tests(Link stigma scale, CES-D, GHQ-12) before and after using the app for 2 weeks.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 (intervention group)The Mental App, which was designed according to a questionnaire survey conducted before this study, was installed on the students smartphone and the psychological tests (Link stigma scale, CES-D, GHQ-12) were performed on the same day. After using the App for two weeks, the students completed a questionnaire survey and underwent the same psychological tests. We compared the results between the app user and non-user group.
Interventions/Control_2 (control group)Students have the psychological tests (Link stigma scale, CES-D, GHQ-12). After two weeks, the students completed a questionnaire survey and underwent the same psychological tests. We compared the results between the app user and non-user group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Students in Kyushu University
Key exclusion criteria We excluded the students who cannot understand Japanese.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kosuke
Middle name
Last name Kajitani
Organization Kyushu University
Division name Center for Health Sciences and Counseling
Zip code 816-8580
Address 744, Motooka, Nishi-ku, Fukuoka, JAPAN
TEL 092-802-5116
Email kkajitani@chc.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Kajitani
Organization Kyushu University
Division name Center for Health Sciences and Counseling
Zip code 092-802-5116
Address 744 Motooka, Nishi-ku, Fukuoka, JAPAN
TEL 092-802-5116
Homepage URL
Email kkajitani@chc.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Center for Health Sciences and Counseling

Institute
Department

Funding Source
Organization the Japan Society for the Promotion of Science KAKENHI
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of the Faculty of Arts and Science and Center for Health Sciences and Counseling at Kyushu University
Address 744, Motooka, Nishi-ku, Fukuoka, 816-8580, JAPAN
Tel 092-802-6043
Email okamoto@artsci.kyushu-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 13 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046021
Publication of results Published

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046021
Number of participants that the trial has enrolled 68
Results 
A total of 68 students participated, of which 57 students completed the study(app user = 28, non-user = 29). The mean number of days spent using the app was 5.66(3.16).The mean total screen time of the app was 9:03(6:41). There was a significant between-group difference in GHQ-12 score (p=0.007).
Results date posted
2020 Year 11 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 09 Month 26 Day
Baseline Characteristics 
app user group
age (SD): 21.8(1.60)
sex:M/F: 20/8
non-user group
age(SD): 21.7 (3.30)
sex:M/F: 20/9
Participant flow 
All participants were students in Kyushu University. In the psychology class, we explained the study's outline and asked for volunteers. Written informed consent was obtained from each participant after providing them with information about the study.
Adverse events 
none
Outcome measures 
log data: screen time, days spent using the app, number of actions
psychological tests: CES-D, LSS, GHQ-12
Participants' impression of the Mental App.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 02 Month 09 Day
Date of IRB
2016 Year 02 Month 09 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
2019 Year 09 Month 30 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2020 Year 02 Month 29 Day

Other
Other related information

Management information
Registered date
2020 Year 05 Month 08 Day
Last modified on
2020 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046021