UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Comparative Study of the Effects of Individual Cognitive Behavior Therapy and Computerized Cognitive Behavior Therapy on Patients with Social Anxiety Disorder.
Title of the study (Brief title)	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	Kentaro Shirotsuki
Organization	Musashino University
Division name	Faculty of Human Sciences
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	Kentaro Shirotsuki
Organization	Musashino University
Division name	Faculty of Human Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000034157