UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034879 |
|---|---|
| Receipt number | 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 | 2020/05/15 11:27:17 |
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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
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
h8tmdp02@s.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin Univ.
Institute
Department
Personal name
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
shinri@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
Completed
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
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 13 | Day |
Last modified on
| 2020 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039763
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
