UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040332 |
|---|---|
| Receipt number | 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 10:48:14 |
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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
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
kkajitani@chc.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Center for Health Sciences and Counseling
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046021
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| Registered date | File name |
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