UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059731 |
|---|---|
| Receipt number | R000068310 |
| Scientific Title | A randomized controlled trial evaluating the effectiveness of the MYPLAN Japanese version smartphone application for suicide prevention among patients with suicidal ideation |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/10 21:59:02 |
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Basic information
Public title
Randomized controlled trial of a smartphone application for suicide prevention (MYPLAN Japanese version)
Acronym
MYPLAN-J RCT
Scientific Title
A randomized controlled trial evaluating the effectiveness of the MYPLAN Japanese version smartphone application for suicide prevention among patients with suicidal ideation
Scientific Title:Acronym
MYPLAN-J RCT
Region
| Japan |
Condition
Condition
Psychiatic disorders, with suicidal ideation
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a randomized controlled trial using the Japanese version of the MYPLAN application among patients with suicidal ideation, and to evaluate its effectiveness for suicide prevention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of suicide attempt or self-harm within 8 weeks after enrollment
Key secondary outcomes
PHQ-9 (depression)
SF-8 (quality of life)
Original questionairs (ability to cope with suicidal ideation, app usability and satisfaction)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Standard psychiatric treatment with MYPLAN Japanese version smartphone application, used over 15 minutes per day from enrollment.
Interventions/Control_2
Standard psychiatric treatment; MYPLAN app provided after 8 weeks.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Sixteen years of age or older
2. Suicidal ideation (PHQ-9 Item 9 score of 1 or higher.)
3. Owns a smartphone and able to install the app
4. Understands Japanese
5. Provides written informed consent
Key exclusion criteria
1. No smartphone / unable to install app
2. Cannot understand Japanese
3. Current psychotic symptoms
4. Cognitive impairment
5. Considered unsuitable by treating psychiatrist
6. Other investigator-determined reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Kawanishi |
Organization
Sapporo Medical University Hospital
Division name
Department of Neuropsychiatry
Zip code
0608556
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
+81-11-611-2111
chiaki.kawanishi@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Narita |
Organization
Sapporo Medical University Hospital
Division name
Department of Neuropsychiatry
Zip code
0608556
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
+81-11-611-2111
Homepage URL
knarita@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Hospital
Institute
Department
Personal name
Chiaki Kawanishi
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Hospital Clinical Research Review Board
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
+81-11-611-2111
ji-rskk@sapmed.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
| 2025 | Year | 12 | Month | 01 | 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
Results
Results date posted
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068310
