UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049843 |
|---|---|
| Receipt number | R000056758 |
| Scientific Title | Mobile phone application for suicide prevention : the feasibility study |
| Date of disclosure of the study information | 2022/12/31 |
| Last modified on | 2025/09/16 11:57:08 |
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Basic information
Public title
Mobile phone application for suicide prevention : the feasibility study
Acronym
A study of mobile phone app for suicide prevention
Scientific Title
Mobile phone application for suicide prevention : the feasibility study
Scientific Title:Acronym
A study of mobile phone app for suicide prevention
Region
| Japan |
Condition
Condition
suicide attempter
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usability and the safety of the Japanese version of mobile phone aplication for suicide prevention.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The original assessment seat for the application including the information about the usability and the safety.
The primary outcome will be measured 2 weeks after enrollment.
Key secondary outcomes
SF8 Health Survey
Beck Depression Inventory Second Edition
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
All participants are encouraged to use the app for 15 minutes per day.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must have a smartphone (iPhone or Android phone) and understand sufficient Japanese to use MyPlan.
Key exclusion criteria
Particilpants who have history of past suicide attempts are excluded.
Participants who have pyschotic symptoms or cognitive disorder are excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Kawanishi |
Organization
Sapporo Medical University Hospital
Division name
Neuropsychiatry
Zip code
0608556
Address
S1 W17, Chuo-ku, Sapporo, Japan
TEL
0116112111
knarita@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Narita |
Organization
Sapporo Medical University Hospital
Division name
Neuropsychiatry
Zip code
0608556
Address
S1 W17, Chuo-ku, Sapporo, Japan
TEL
+81116112111
Homepage URL
knarita@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Sapporo Medical University Hospital
Address
S1 W17, Chuo-ku, Sapporo, Japan
Tel
0116112111
N/A
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
| 2022 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
Results
A total of 14 participants were enrolled, and 13 were included in the analysis. Usability evaluation showed generally favorable results, with higher ratings for screen visibility and willingness to recommend the app to others.No worsening of psychiatric symptoms or adverse events was identified, confirming the safety of the intervention.
Results date posted
| 2025 | Year | 09 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 14 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056758
