UMIN-CTR Clinical Trial

Basic information
Public title	Cross-sectional study of the effect of the functional assertiveness and experimental avoidance on mental health in Japanese college students
Acronym	Cross-sectional study of the effect of the functional assertiveness and experimental avoidance on mental health
Scientific Title	Cross-sectional study of the effect of the functional assertiveness and experimental avoidance on mental health in Japanese college students
Scientific Title:Acronym	Cross-sectional study of the effect of the functional assertiveness and experimental avoidance on mental health
Region	Japan

Condition
Condition	healthy college students
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the effect of the functional assertivenes and experimental avoidance on mental health in Japanese college students
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to clarify the effect of the functional assertiveness and experimental avoidance on satisfaction with life in Japanese college students
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	mental health: Kessler 10 (K10)
Key secondary outcomes	satisfaction with life: the Satisfaction With Life Scale (SWLS)

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	18 years-old <=
Age-upper limit	30 years-old >
Gender	Male and Female
Key inclusion criteria	healthy college students
Key exclusion criteria	college students with foreign nationality
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Mitamura
Organization	Ritsumeikan University
Division name	College of Comprehensive Psychology
Zip code
Address	2-150, Iwakura-cho, Ibaraki, Osaka
TEL	072-665-2490
Email	just_say_no1992@orange.zero.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Mitamura
Organization	Ritsumeikan University
Division name	College of Comprehensive Psychology
Zip code
Address	2-150, Iwakura-cho, Ibaraki, Osaka
TEL	072-665-2490
Homepage URL
Email	just_say_no1992@orange.zero.jp

Sponsor
Institute	Ritsumeikan University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

IRB Contact (For public release)
Organization
Address
Tel
Email

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	立命館大学

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 04 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	Completed
Date of protocol fixation	2018 Year 05 Month 31 Day
Date of IRB	2017 Year 05 Month 22 Day
Anticipated trial start date	2018 Year 06 Month 05 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2018 Year 05 Month 31 Day
Last modified on	2019 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037427