UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031147 |
|---|---|
| Receipt number | 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 18:52:06 |
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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
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
seiogawa1964@nifty.com
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035578
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| Registered date | File name |
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