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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030199
Receipt No. R000034494
Scientific Title Effects of intervention focused on helping the individual elicit positive self concept
Date of disclosure of the study information 2017/12/04
Last modified on 2018/12/03

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Basic information
Public title Effects of intervention focused on helping the individual elicit positive self concept
Acronym Effects of intervention focused on helping the individual elicit positive self concept
Scientific Title Effects of intervention focused on helping the individual elicit positive self concept
Scientific Title:Acronym 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
1st name
Middle name
Last name JUN INOUE
Organization Hamamatsu University School of Medicine
Division name Department of Child and Adolescent Psychiatry
Zip code
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
1st name
Middle name
Last name JUN INOUE
Organization Hamamatsu University School of Medicine
Division name Department of Child and Adolescent Psychiatry
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 12 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
2017 Year 11 Month 20 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000034494

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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