UMIN-CTR Clinical Trial

Basic information
Public title	Text messaging for psychiatric outpatients: Effect on Help-Seeking
Acronym	Text messaging for psychiatric outpatients
Scientific Title	Text messaging for psychiatric outpatients: Effect on Help-Seeking
Scientific Title:Acronym	Text messaging for psychiatric outpatients
Region	Japan

Condition
Condition	Mental illness
Classification by specialty	Psychiatry Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to investigate changes in psychiatric outpatients' help-seeking by resulting from mobile phone text messaging.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Help-Seeking (Baseline, 3 months, 6 months)
Key secondary outcomes	POMS2 short versions Self-Harming Behaviors

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Participants are randomly assigned to Intervention group or wait-list control group. Intervention group receive text messaging for 3 months from baseline.
Interventions/Control_2	After 3 months, wait-list control group receive text messaging for 3 months from baseline
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Aged 20 years or over Psychiatric outpatient Possessing a mobile phone or smartphone Attending judged that the patient have competency to join this study
Key exclusion criteria	Under age 20 Attending did not judge that the patient have competency to join this study
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Toyohiko Middle name Last name Kodama
Organization	University of Occupational and Environmental Health, Japan
Division name	School of Health Sciences
Zip code	8078555
Address	1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuok
TEL	0936031611
Email	t-kodama@health.uoeh-u.ac.jp

Public contact
1st name of contact person	1st name Toyohiko Middle name Last name Kodama
Organization	University of Occupational and Environmental Health, Japan
Division name	School of Health Sciences
Zip code	8078555
Address	1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-8555, Japan
TEL	0936031611
Homepage URL
Email	t-kodama@health.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Japan
Institute
Department

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	Mie Prefectural Mental Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mie University
Address	2-174 Edobashi Tsu, Mie 5148507, Japan
Tel	059-231-5246
Email	mie-cts1@clin.medic.mie-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	2016 Year 10 Month 24 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	45
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	Completed
Date of protocol fixation	2016 Year 09 Month 15 Day
Date of IRB	2016 Year 08 Month 25 Day
Anticipated trial start date	2016 Year 09 Month 20 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 17 Day
Last modified on	2019 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027910