UMIN-CTR Clinical Trial

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
Last 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
Email	eiji@faculty.chiba-u.jp

Public contact
1st 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
Email	danxiety2017@yahoo.co.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036571