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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034879
Receipt No. R000039763
Scientific Title The effect of early treatment program for college students with social anxiety tendencies
Date of disclosure of the study information 2018/11/20
Last modified on 2019/05/14

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Basic information
Public title The effect of early treatment program for college students with social anxiety tendencies
Acronym The effect of early treatment program for college students with social anxiety tendencies
Scientific Title The effect of early treatment program for college students with social anxiety tendencies
Scientific Title:Acronym The effect of early treatment program for college students with social anxiety tendencies
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of the program for college students with social anxiety tendencies of such symptoms as stranger anxiety and/or avoidance of social relationship.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of mood and/or activity recorded on self-monitoring sheets by subjects (every day for eight weeks)
Key secondary outcomes 5 questionnaire surveys (LSAS, SIAS, SDS, FFMQ, GHQ60) are to be conducted on the first day, the last day and the follow-up day of the program.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The early treatment program for college students with social anxiety tendencies
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 College students with social anxiety tendencies of such symptoms as stranger anxiety and/or avoidance of social relationship.
Key exclusion criteria Nothing
Target sample size 6

Research contact person
Name of lead principal investigator
1st name keiko
Middle name
Last name Murai
Organization Kobe Gakuin Univ.
Division name The Faculty of Psychology
Zip code 651-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe
TEL 078-974-1551
Email murai@psy.kobegakuin.ac.jp

Public contact
Name of contact person
1st name Konatsu
Middle name
Last name Tanaka
Organization Kobe Gakuin Univ.
Division name The Graduate Scholl of Humanities and Sciences
Zip code 651-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe
TEL 078-974-1551
Homepage URL
Email h8tmdp02@s.kobegakuin.ac.jp

Sponsor
Institute Kobe Gakuin Univ.
Institute
Department

Funding Source
Organization Kobe Gakuin Univ.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kobe Gakuin Univ.
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe
Tel 0789741551
Email kgu@j.kobegakuin.ac.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
2018 Year 11 Month 20 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 8
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
2018 Year 11 Month 15 Day
Date of IRB
2019 Year 01 Month 09 Day
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 13 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039763

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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