UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043861 |
|---|---|
| Receipt number | R000050055 |
| Scientific Title | A clinical trial of online cognitive behavioral therapy for panic patients who remain symptomatic after pharmacotherapy (G29036) (G30012) with follow-up outcomes up to 3 years |
| Date of disclosure of the study information | 2021/04/07 |
| Last modified on | 2021/11/26 18:21:51 |
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Basic information
Public title
A clinical trial of online cognitive behavioral therapy for panic patients who remain symptomatic after pharmacotherapy (G29036) (G30012) with follow-up outcomes up to 3 years
Acronym
A clinical trial of online cognitive behavioral therapy for panic patients who remain symptomatic after pharmacotherapy with follow-up outcomes up to 3 years
Scientific Title
A clinical trial of online cognitive behavioral therapy for panic patients who remain symptomatic after pharmacotherapy (G29036) (G30012) with follow-up outcomes up to 3 years
Scientific Title:Acronym
A clinical trial of online cognitive behavioral therapy for panic patients who remain symptomatic after pharmacotherapy with follow-up outcomes up to 3 years
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 examine the mid- to long-term effects of online cognitive-behavioral therapy for panic patients who remain symptomatic after pharmacotherapy by tracking its effects up to 3 years later.
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
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Prior studies (1) completion of a pilot randomized controlled trial of the effects of online cognitive-behavioral therapy for panic disorder in a usual care group (G29036), and (2) completion of a rescue trial (G30012).
Key exclusion criteria
No setting
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
043-226-2027
TEL
043-226-2027
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
yoichi-seki@chiba-u.jp
Sponsor or person
Institute
Chiba University's Graduate School of Medicine and School of Medicine
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Research
Management information
Registered date
| 2021 | Year | 04 | Month | 07 | Day |
Last modified on
| 2021 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050055
