UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048345 |
|---|---|
| Receipt number | R000055100 |
| Scientific Title | The research on impact of attributes of people with mental disorder on treatment stigma |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2022/07/12 10:48:48 |
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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
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
m.tamura.cmc@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055100
