UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033680 |
|---|---|
| Receipt number | R000038398 |
| Scientific Title | 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 | 2020/04/28 18:59:07 |
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Basic information
Public title
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
Acronym
Effect study of the TAU group in RCT of the remote personal cognitive-behavioral therapy for panic disorder patients
Scientific Title
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
Scientific Title:Acronym
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
| 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
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 Hospital Clinical Research Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
The Chiba University Clinical Research Center (CCRC)
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
Tel
043-226-2027
yoichi-seki@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
| 2018 | Year | 08 | Month | 08 | 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
12
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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 08 | Month | 08 | Day |
Last modified on
| 2020 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038398
