UMIN-CTR Clinical Trial

Basic information
Public title	The research on impact of attributes of people with mental disorder on treatment stigma
Acronym	The research on impact of attributes of people with mental disorder on treatment stigma
Scientific Title	The research on impact of attributes of people with mental disorder on treatment stigma
Scientific Title:Acronym	The research on impact of attributes of people with mental disorder on treatment stigma
Region	Japan

Condition
Condition	Mental disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the impact of gender, age, and other attributes of people with mental disorders on their treatment stigma through an online survey.
Basic objectives2	Others
Basic objectives -Others	Online survey
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total and subscale scores of Barriers to Access to Care Evaluation scale version3(BACEv3) Japanese version.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	This study is based on secondary use of data collected by Hongo et al. during the course of the study, "Reliability and Validity of the Japanese Version of the Barriers to Access to Care Evaluation Scale Version 3 for People With Mental Disorders: an Online Survey Study"(https://doi.org/10.3389/fpsyg.2021.760184). The inclusion criteria of Hongo's study is as follows. (1) People who have been present with full explanation about the study, and have given their free and voluntary consent based on a thorough understanding of the study. (2) People who are between 20 and 65 years of age at the time of obtaining consent.
Key exclusion criteria	(1) People with intellectual disability, dementia, positive symptoms of schizophrenia, people at imminent risk of suicide, or people deemed inappropriate by the therapist or examiner.
Target sample size	260

Research contact person
Name of lead principal investigator	1st name Fumiyo Middle name Last name Oshima
Organization	Chiba University
Division name	Research Center for Child Mental Development
Zip code	260-8677
Address	1-8-1, Inohana, Chuou-ku. Chiba-shi, Chiba, Japan.
TEL	043-226-2975
Email	c21ujsw35117c@faculty.gs.chiba-u.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Tamura
Organization	Chiba University
Division name	Department of Cognitive Behavioral Physiology
Zip code	260-8677
Address	1-8-1, Inohana, Chuou-ku. Chiba-shi, Chiba, Japan
TEL	043-226-2027
Homepage URL
Email	m.tamura.cmc@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Ministry of education
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	The Ethics Review Committee of the Graduate School of Medicine, Chiba University
Address	1-8-1, Inohana, Chuou-ku. Chiba-shi, Chiba, Japan
Tel	043-226-2027
Email	inohana-rinri@chiba-u.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 07 Month 12 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	268
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	No longer recruiting
Date of protocol fixation	2022 Year 06 Month 23 Day
Date of IRB	2022 Year 06 Month 23 Day
Anticipated trial start date	2022 Year 06 Month 23 Day
Last follow-up date	2022 Year 06 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Secondary statistical analysis will be performed on the results of a web-based survey (including background information such as age, gender, and primary diagnosis, as well as the Japanese version of the Barriers to Access to Care Evaluation scale v3 (BACEv3)).

Management information
Registered date	2022 Year 07 Month 12 Day
Last modified on	2022 Year 07 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055100