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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031147
Receipt No. R000035578
Scientific Title The effects and predictors of cognitive-behavioral therapy for panic disorder and social anxiety disorder
Date of disclosure of the study information 2018/02/05
Last modified on 2020/08/07

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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