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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043862
Receipt No. R000050056
Scientific Title Secondary analysis of data from an online cognitive-behavioral therapy trial (G29036) (G30012) for panic disorder patients who remain symptomatic after pharmacotherapy to examine the effectiveness of a session dealing with " imagery rescripting for early traumatic memory.
Date of disclosure of the study information 2021/04/07
Last modified on 2021/04/07

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Basic information
Public title Secondary analysis of data from an online cognitive-behavioral therapy trial (G29036) (G30012) for panic disorder patients who remain symptomatic after pharmacotherapy to examine the effectiveness of a session dealing with " imagery rescripting for early traumatic memory.
Acronym Secondary analysis of data from an online cognitive-behavioral therapy trial for panic disorder patients who remain symptomatic after pharmacotherapy to examine the effectiveness of a session dealing with " imagery rescripting for early traumatic memory.
Scientific Title Secondary analysis of data from an online cognitive-behavioral therapy trial (G29036) (G30012) for panic disorder patients who remain symptomatic after pharmacotherapy to examine the effectiveness of a session dealing with " imagery rescripting for early traumatic memory.
Scientific Title:Acronym Secondary analysis of data from an online cognitive-behavioral therapy trial for panic disorder patients who remain symptomatic after pharmacotherapy to examine the effectiveness of a session dealing with " imagery rescripting for early traumatic memory.
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to clarify the effectiveness of the "session dealing with the memory of past panic symptoms" that was additionally used by secondary analysis of data from remote cognitive behavioral therapy for patients with panic disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Panic Disorder Severity Scale (PDSS)
Key secondary outcomes

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 Cognitive behavioral therapy
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 26

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name 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
Zip code 260-8677
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Yoichi
Middle name
Last name Seki
Organization Chiba University Hospital
Division name Cognitive Behavioral Therapy Center
Zip code 260-8677
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Homepage URL
Email yoichi-seki@chiba-u.jp

Sponsor
Institute Chiba University's Graduate School of Medicine and School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University's Graduate School of Medicine and School of Medicine
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
Tel 043-222-7171
Email inohana-kyodo@chiba-u.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
2021 Year 04 Month 07 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 08 Day
Date of IRB
2021 Year 02 Month 08 Day
Anticipated trial start date
2021 Year 02 Month 08 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 07 Day
Last modified on
2021 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050056

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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