UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032064 |
|---|---|
| Receipt number | R000036571 |
| Scientific Title | A pilot traial of False Safety Behavior Elimination Therapy for Social Anxiety Disorder. |
| Date of disclosure of the study information | 2018/04/09 |
| Last modified on | 2019/04/09 15:51:46 |
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Basic information
Public title
A pilot traial of False Safety Behavior Elimination Therapy for Social Anxiety Disorder.
Acronym
A piloy traial of False Safety Behavior Elimination Therapy for social anxiety Disorder.
Scientific Title
A pilot traial of False Safety Behavior Elimination Therapy for Social Anxiety Disorder.
Scientific Title:Acronym
A piloy traial of False Safety Behavior Elimination Therapy for social anxiety Disorder.
Region
| Japan |
Condition
Condition
Social Anxiety Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of False Safety Behavior Elimination Therapy for Social Anxiety Disorder.
Basic objectives2
Others
Basic objectives -Others
To examine the applicability of False Safety Behavior Elimination Therapy for Japanese Social Anxiety Disorder.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Liebowitz Social Anxiety Scale (LSAS)
Key secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Generalized Anxiety Disorder -7 (GAD-7)
EuroQol 5 Dimension (EQ-5D-5L)
Subtle Avoidance Frequency Examination (SAFE)
Anxiety Control Questionnaire (ACQ)
Beck Depression Inventory(BDI)
Sheehan Disability Scale (SDS)
Clinical Global Impression -Severity (CGI)
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
| Maneuver |
Interventions/Control_1
Cognitive Behavioral Therapy (once a week, 5weeks Intervention, 4weeks post observation period)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Primary diagnosis of Social Anxiety Disorder using the Mini- International Neuropsychiatric Interview, DSM-5.
The patients' LSAS score is above 30.
Key exclusion criteria
psychosis, major depression, bipolar, active suicidality, organic brain disorder, substance abuse or dependence, antisocial personality disorder, other severe mental / physical condition
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Shimizu |
Organization
Graduate School of Medicine Chiba University,Chiba University Hospital
Division name
Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology,Cognitive Behavioral Therapy Center
Zip code
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Honami Arai |
Organization
Doshisha University
Division name
Graduate School of Psychology
Zip code
Address
1-3 Tatara-to-dani, Kyotanabe-shi, Kyoto, Japan
TEL
0774-65-8220
Homepage URL
danxiety2017@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
| 2018 | Year | 04 | Month | 09 | 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
6
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 | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 01 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036571
