UMIN-CTR Clinical Trial

Basic information
Public title	The effects and predictors of cognitive-behavioral therapy for panic disorder and social anxiety disorder
Acronym	Cognitive-behavioral therapy for panic disorder and social anxiety disorder
Scientific Title	The effects and predictors of cognitive-behavioral therapy for panic disorder and social anxiety disorder
Scientific Title:Acronym	Cognitive-behavioral therapy for panic disorder and social anxiety disorder
Region	Japan

Condition
Condition	panic disorder, social anxiety disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Our study aims to show the effevtiveness of cognitive-behavioral therapy for panic disorder and social anxiety disorder. Moreover, this study aims to examine the predictors of symptoms improvements in cognitive-behavioral therapy for panic disorder and social anxiety disorder .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Panic Disorder Severity Scale(panic disorder) Liebowitz Social Anxiety Scale(social anxiety disorder) We evaluate these scales before and after interevention.
Key secondary outcomes	Panic disorder (i) Fear Questionnaire (ii) Mobility Inventory (iii)Agoraphobic Cognitions Questionnaire (iv) Body Sensations Questionnaire (v) Anxiety Sensitivity Index (vi) Marks' Disability Scale (vii) Symptom Checklist 90 Reversed (viii)Short Form 36 (ix) NEO Five Factor Index Social anxiety disorder (i)Brief Fear of Negative Evaluations Scale (ii) Social Phobia Scale (iii)Social Interaction Anxiety Scale (iv) Focus of Attention Questionnaire (v) Anxiety Sensitivity Index (vi) Marks' Disability Scale (vii)Symptom Checklist 90 Reversed (viii)NEO Five Factor Index (ix)Short Form 36

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	Behavior,custom
Interventions/Control_1	Panic disorder; ten sessions, with each lasting approximately 120 minutes. Social anxiety disorder; twelve sessions, with each lasting approximately 120 minutes.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(i) principal Axis I diagnosis of panic disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, as assessed by the Structured Clinical Interview for DSM-IV(SCID) (ii) highly motivated to receive cognitive-behavioral therapy. (iii) (panic disorder only)free from benzodiazepine use prior to cognitive-behavioral therapy entry, because these drugs may interact negatively with exposure treatments during cognitive-behavioral therapy.
Key exclusion criteria	current psychosis, bipolar disorder, and substance-use disorder.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Sei Middle name Last name Ogawa
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code	467-8601
Address	Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-853-8271
Email	seiogawa1964@nifty.com

Public contact
Name of contact person	1st name Sei Middle name Last name Ogawa
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive-Behavioral Medicine
Zip code	467-8601
Address	Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-851-5511
Homepage URL
Email	seiogawa1964@nifty.com

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science, and Technology.
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	Clinical Research Management Center, Nagoya City University Hospital
Address	Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel	052-658-7215
Email	clinical_research@med.nagoya-cu.ac.jp

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 02 Month 05 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
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	Enrolling by invitation
Date of protocol fixation	2001 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date	2001 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 05 Day
Last modified on	2020 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035578