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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030013
Receipt No. R000034157
Scientific Title A Comparative Study of the Effects of Individual Cognitive Behavior Therapy and Computerized Cognitive Behavior Therapy on Patients with Social Anxiety Disorder.
Date of disclosure of the study information 2017/11/30
Last modified on 2018/11/23

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Basic information
Public title A Comparative Study of the Effects of Individual Cognitive Behavior Therapy and Computerized Cognitive Behavior Therapy on Patients with Social Anxiety Disorder.
Acronym Examination of effects of individual CBT and CCBT on patients with social social anxiety disorder
Scientific Title A Comparative Study of the Effects of Individual Cognitive Behavior Therapy and Computerized Cognitive Behavior Therapy on Patients with Social Anxiety Disorder.
Scientific Title:Acronym Examination of effects of individual CBT and CCBT on patients with social social anxiety disorder
Region
Japan

Condition
Condition Social Anxiety Disorder
Classification by specialty
Psychosomatic Internal Medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effect of Computerized Cognitive Behavior Therapy (CCBT) on patients with social anxiety disorder (SAD). At the present time, there are currently limited therapists who can conduct CBT. In recent years, self-help conducted by patients / clients themselves through reading and CCBT has developed. CCBT is a type of CBT by using computers and the Internet, it is one of self-help methods, and it is also required to proceed with the effect study in SAD. In this study, we aim to compare the effect of cognitive behavioral therapy in counseling form used as conventional psychotherapy and the effect of psychoeducational CCBT program for SAD patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Cognitive Behavior Therapy
Interventions/Control_2 Computerized Cognitive Behavior Therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Those whose doctor's permission was obtained.
2) Those who have the symptoms with social anxiety disorder.
Key exclusion criteria 1) Individualls who have the high risk of suicide.
2) Those who have high depressive symptoms.
3) Patients deemed inappropriate for the participation by the doctor.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Shirotsuki
Organization Musashino University
Division name Faculty of Human Sciences
Zip code
Address 3-3-3, Ariake, Koto-ku, Tokyo, Japan
TEL 03-5530-7624
Email kenshiro@musashino-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Shirotsuki
Organization Musashino University
Division name Faculty of Human Sciences
Zip code
Address 3-3-3, Ariake, Koto-ku, Tokyo, Japan
TEL 03-5530-7624
Homepage URL
Email kenshiro@musashino-u.ac.jp

Sponsor
Institute Musashino University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology - Japan
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
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 11 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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
2016 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 17 Day
Last modified on
2018 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034157

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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