UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of intervention focused on helping the individual elicit positive self concept
Title of the study (Brief title)	Effects of intervention focused on helping the individual elicit positive self concept
Region	Japan

Condition
Condition	N/A(Healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of intervention focused on helping the individual elicit positive self concept
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Self-Positiveness Scale
Key secondary outcomes	state self-esteem scale multiple mood scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Interventions to recall episodic memory of coping with problems
Interventions/Control_2	Interventions to consider perceived self by significant others
Interventions/Control_3	Control: neutral question
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Healty adults 2.Capability of informed consent based on their own decision 3.Individuals without past or current history of serious medical illness
Key exclusion criteria	1.Individuals with past or current history psychiatric illness 2.Individuals with past or current history of serious medical illness 3.Individuals with intelligence score IQ<=70 on the Japanese Adult Reading Test 4.Inappropriate Individuals for this study judged by physician.
Target sample size	60

Research contact person
Name of lead principal investigator	JUN INOUE
Organization	Hamamatsu University School of Medicine
Division name	Department of Child and Adolescent Psychiatry
Address	1-20-1 Handayama,Hamamatsu, Shizuoka 431-3192, Japan
TEL	053-435-2058
Email	juninoue@hama-med.ac.jp

Public contact
Name of contact person	JUN INOUE
Organization	Hamamatsu University School of Medicine
Division name	Department of Child and Adolescent Psychiatry
Address	1-20-1 Handayama,Hamamatsu, Shizuoka 431-3192, Japan
TEL	053-435-2295
Homepage URL
Email	juninoue@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	The Mental Health Okamoto Memorial Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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	2017 Year 12 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 20 Day
Anticipated trial start date	2017 Year 11 Month 30 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

Management information
Registered date	2017 Year 11 Month 30 Day
Last modified on	2018 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034494