UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the relationship between anxiety and cognition
Title of the study (Brief title)	Study on the relationship between anxiety and cognition
Region	Japan

Condition
Condition	Psychiatric disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We clarify the relationship between anxiety and cognition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcomes State-Trait Anxiety Inventory Japanese Adult Reading Test Japanese version of a short form of the Profile of Emotional Competence Term for evaluation About 3.6.12 months
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	6 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	An outpatient with psychiatric disorder
Key exclusion criteria	Those whose research participants judged inappropriate for participation in this survey
Target sample size	1000

Research contact person
Name of lead principal investigator	Yosie Tokumaru
Organization	Gifu University Graduate School of Medicine
Division name	Department of Psychiatry and Psychotherapy
Address	Yanagito 1-1 Gifu-city Gifu
TEL	058-230-6000
Email	rinri@gifu-u.ac.jp

Public contact
Name of contact person	Yosie Tokumaru
Organization	Gifu University Graduate School of Medicine
Division name	Department of Psychiatry and Psychotherapy
Address	Yanagito 1-1 Gifu-city Gifu
TEL	058-230-6000
Homepage URL
Email	rinri@gifu-u.ac.jp

Sponsor
Institute	Gifu university
Institute
Department

Funding Source
Organization	Gifu university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2018 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 09 Month 20 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	State-Trait Anxiety Inventory,Japanese Adult Reading Test,Japanese version of a short form of the Profile of Emotional Competence

Management information
Registered date	2018 Year 09 Month 20 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039001