UMIN-ICDS 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 2023/12/14 12:48:40

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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

Email

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


Email

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

Email

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


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

Enrolling by invitation

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


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

2023 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056758


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name