UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030013 |
|---|---|
| Receipt number | 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 11:43:09 |
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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
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
kenshiro@musashino-u.ac.jp
Sponsor or person
Institute
Musashino University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034157
