UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025220 |
|---|---|
| Receipt number | R000028926 |
| Scientific Title | A randomized controlled trial of cognitive behavior therapy as an adjunct to usualcare for panic disorder refractory to medical treatment |
| Date of disclosure of the study information | 2016/12/11 |
| Last modified on | 2017/12/11 10:14:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A randomized controlled trial of cognitive behavior therapy as an adjunct to usualcare for panic disorder refractory to medical treatment
Acronym
RCT about the effectiveness of the CBT for medical treatment-resistant panic disorder patients
Scientific Title
A randomized controlled trial of cognitive behavior therapy as an adjunct to usualcare for panic disorder refractory to medical treatment
Scientific Title:Acronym
RCT about the effectiveness of the CBT for medical treatment-resistant panic disorder patients
Region
| Japan |
Condition
Condition
panic disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of cognitive behavioral therapy as an adjunct to usual care when compared to usual care alone in patients with panic disorder refractory to medical treatment.
Basic objectives2
Others
Basic objectives -Others
To examine clinical and cost effectiveness of cognitive behavioral therapy as an adjunct to usual care 16weeks after.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
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)
MDS(Mental Defeat Scale)
CFS(Cognitive Flexibility Scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cognitive behavioral therapy(16 weeks)
Interventions/Control_2
usual care only(16 weeks)
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
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | 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
Zip code
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 | |
| Middle name | |
| Last name | Yoichi Seki |
Organization
Chiba University Hospital
Division name
Cognitive Behavioral Therapy Center
Zip code
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-222-7171
Homepage URL
yoichi-seki@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
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
Address
Tel
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
| 2016 | Year | 12 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 08 | 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
| 2016 | Year | 12 | Month | 11 | Day |
Last modified on
| 2017 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028926
