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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039931
Receipt No. R000044754
Scientific Title The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Date of disclosure of the study information 2020/05/01
Last modified on 2021/03/26

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Basic information
Public title The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Acronym The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Scientific Title The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Scientific Title:Acronym The effect of concentrated video feedback sessions of individual cognitive behavior therapy program in social anxiety disorder
Region
Japan

Condition
Condition Social anxiety disorder
Classification by specialty
Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare the effects of a counseling-type CBT program, which is conventionally used as psychotherapy, and a CBT program that focuses on cognitive intervention to reduce the burden of video feedback.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japanese version of Liebowitz Social Anxiety Scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Cognitive behavior therapy: 8 times sessions
1 time video feedback
Interventions/Control_2 Cognitive behavior therapy: 8 times sessions
3 times video feedback
Interventions/Control_3 Questionnaire survey
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

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients diagnosed with social anxiety
Key exclusion criteria High Suicide Risk
Individuals with severe depressive symptoms
Individuals judged difficult by the attending physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kentaro
Middle name
Last name Shirotsuki
Organization Musashino University
Division name Faculty of Human Sciences
Zip code 1358181
Address 3-3-3, Ariake, Koto-ku, Tokyo
TEL 0355307624
Email kenshiro@musashino-u.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Shirotsuki
Organization Musashino University
Division name Faculty of Human Sciences
Zip code 1358181
Address 3-3-3, Ariake, Koto-ku, Tokyo
TEL 0355307624
Homepage URL
Email kenshiro@musashino-u.ac.jp

Sponsor
Institute Musashino University
Institute
Department

Funding Source
Organization The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Faculty of Human Sciences,Musashino University, Research Ethics Committee
Address 3-3-3, Ariake, Koto-ku, Tokyo
Tel 03-5530-7448
Email masako_k@musashino-u.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
2020 Year 05 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 13 Day
Date of IRB
2018 Year 04 Month 23 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2023 Year 03 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
2020 Year 03 Month 25 Day
Last modified on
2021 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044754

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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