UMIN-CTR Clinical Trial

Basic information
Public title	Test to confirm the effectiveness of the me-fullness application in promoting well-being
Acronym	Test to confirm the effectiveness of the me-fullness application in promoting well-being
Scientific Title	Test to confirm the effectiveness of the me-fullness application in promoting well-being
Scientific Title:Acronym	Test to confirm the effectiveness of the me-fullness application in promoting well-being
Region	Japan

Condition
Condition	healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to grasp the actual situation of stress and mental health problems of local government employees in the areas affected by the Great East Japan Earthquake and to establish the effectiveness of the me-fullness application for improving mental health.
Basic objectives2	Others
Basic objectives -Others	We will also examine whether the me-fullness application is effective for local government employees' anxiety about possible future disasters and the stress of communicating this anxiety to local government residents.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Before and after one month of use of the me-fullness application, psychological test scores (Chalder Fatigue Scale, Athens Insomnia Scale, Japanese version of PANAS, Four Factors of Happiness, Mental Resilience Scale, Depression Anxiety Stress Scale (DASS-21), PTGI-SF-J: Japanese version - post traumatic stress) were administered to the subjects. (Growth Scale Short Version, Imposter Phenomenon Checklist) to identify psychological states.
Key secondary outcomes	Before and after using the me-fullness application for one month, study participants will be interviewed to determine changes.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	The intervention will be conducted using me-fullness, an application created by POLA Chemical Industries, Inc. using knowledge and data accumulated on facial information to support people who are unable to change their moods due to fatigue or stress for a month.
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	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Male and female employees of Shichigahama Town Hall. Those who have indicated their willingness to participate in the study and have agreed to participate after understanding the explanation.
Key exclusion criteria	1) Medications that may affect the study (fatigue, stress, drugs that claim to improve sleep) Those who are taking or using the drug on a daily basis. 2) Those with hearing problems that interfere with daily life 3) Those participating in other interventional trials 4) Any other person deemed inappropriate by the study investigator.
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Junko Middle name Last name Okuyama
Organization	Tohoku University Hospital
Division name	Department of Physical Medicine and Rehabilitation
Zip code	980-8575
Address	2-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7338
Email	junko.okuyama@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Junko Middle name Last name Okuyama
Organization	Tohoku University Hospital
Division name	Department of Physical Medicine and Rehabilitation
Zip code	980-8575
Address	2-1 Seiryo-machi, Aoba-ku, Sendai
TEL	0227177338
Homepage URL
Email	junko.okuyama@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Department of Rehabilitation, Tohoku University Hospital
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
Tel	0227177338
Email	junko.okuyama@med.tohoku.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	2022 Year 04 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	2022 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date	2022 Year 04 Month 04 Day
Last follow-up date	2027 Year 04 Month 03 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 04 Month 01 Day
Last modified on	2022 Year 04 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054013