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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033680
Receipt No. R000038398
Official scientific title of the study Accompaniment study:Effect study of the treatment as usual group of the randomized controlled trial (UMIN00002998) of the remote personal cognitive-behavioral therapy for panic disorder patients
Date of disclosure of the study information 2018/08/08
Last modified on 2018/08/08

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Basic information
Official scientific title of the study
Accompaniment study:Effect study of the treatment as usual group of the randomized controlled trial (UMIN00002998) of the remote personal cognitive-behavioral therapy for panic disorder patients
Title of the study (Brief title) Effect study of the TAU group in RCT of the remote personal cognitive-behavioral therapy for panic disorder patients
Region
Japan

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

Objectives
Narrative objectives1 Measurement of effects when applying cognitive behavioral therapy to TAU group
Basic objectives2 Others
Basic objectives -Others By intervention by the distant cognitive behavioral therapy in the TAU group, the clinical effect and medical economic effect after 16 weeks of intervention are examined
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Panic Disorder Severity Scale(PDSS)(assessor-rated)
Key secondary outcomes PAS(Panic and Agoraphobia Scale)
PHQ-9(Patient Health Questionnare-9)
GHQ-7(Generalized anxiety disorder-7)
EQ-5D-5L(EuroQol5-Dimension-5Levels)

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 videoconference cognitive behavioral therapy(vCBT)(16weeks)
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 Panic Disorder refractory to medicine(Taking antidepressant or anti-anxiety drugs treatment and had done so for at least 8 weeks at an adequate dose while remaining at least moderately ill(PDSS >=8)).
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 22

Research contact person
Name of lead principal investigator 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
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person Yoichi Seki
Organization Chiba University Hospital
Division name Cognitive Behavioral Therapy Center
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Homepage URL
Email yoichi-seki@chiba-u.jp

Sponsor
Institute Chiba University Hospital Clinical Research Center
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)

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 08 Month 08 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 17 Day
Anticipated trial start date
2018 Year 08 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 08 Day
Last modified on
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038398

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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