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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035578