UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028099 |
|---|---|
| Receipt number | R000032149 |
| Scientific Title | Observational epidemiology database study on cognitive behavioral therapy of the anxiety disorder |
| Date of disclosure of the study information | 2017/07/06 |
| Last modified on | 2017/07/05 15:42:42 |
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Basic information
Public title
Observational epidemiology database study on cognitive behavioral therapy of the anxiety disorder
Acronym
Database study on cognitive behavioral therapy of the anxiety disorder
Scientific Title
Observational epidemiology database study on cognitive behavioral therapy of the anxiety disorder
Scientific Title:Acronym
Database study on cognitive behavioral therapy of the anxiety disorder
Region
| Japan |
Condition
Condition
anxiety disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the patients who received cognitive behavioral therapy of the anxiety disorder (social anxiety disorder(SAD), panic disorder(PD), obsessive compulsive disorder(OCD), PTSD), I collect the symptom with the structured interview and writing by oneself-style question paper and observational epidemiology data of the evaluation standard score of the QOL in the form that a study cooperator providing cognitive behavioral therapy inputs into WEB database and am intended that I analyze it in the place where enough majority cases gathered about the progress.
It is with valuable data for the spread if I can fix the system chasing the progress of the patient who received cognitive-behavioral therapy of the anxiety disorder by this study and thinks that it is significant.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient Health Questionnaire-9 :PHQ-9
Generalized Anxiety Disorder-7 :GAD-7
Working Alliance Inventory Short Form:WAI-SF
The main diagnosis
OCD: Yale-Brown Obsessive-Compulsive Scale :Y-BOCS
SAD: Liebowitz Social Anxiety Scale :LSAS
PD: Panic Disorder Severity Scale :PDSS
PTSD: Impact of Event Scale-Revised:IES-R
An investigation period is one year per one patient. The data are collected with following four points,from the point of the cognitive behavioral therapy of start, a midterm, the point of end, a start one year later.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Correspond to obsessive-compulsive disorder, panic disorder, society anxiety disorder, diagnostic criteria of the PTSD
:mental disease simple posture Creator interview The Mini-International Neuropsychiatric Interview:M.I.N.I. is based.
2 The age at agreement acquisition is less than 65 years old 16 years old or older. The sex does not matter.
3 A document agreement:give the case younger than 20 years to the person 16 years old or older, and the document of the protector agrees; by the free will of the person is provided in the one which understands it enough after having received enough explanation on participating of the final examination.
4 Can understand cognitive-behavioral therapy, and, for at least one year, can practice it continuously; is mental, and have a physical state.
5 Previous treatment, having medical therapy or not do not matter
Key exclusion criteria
1 The person that I am complicated with serious mental disorders such as the brain disorder (including dementia) of the tissue, a psychotic obstacle, bipolar disorder, the drug dependency, and interruption of the cognitive-behavioral therapy is expected for these symptom aggravation.
2 The person that interruption of the cognitive-behavioral therapy is expected to have the risk of the urgent suicide.
3 The person that interruption of the cognitive-behavioral therapy is expected because I repeat an antisocial act.
4 The person that interruption of the cognitive-behavioral therapy is expected to have a serious progressive physical disease.
5 The person who has difficulty in contact with the researcher.
6 The person who, in addition, judged it though a study person in charge or a study partaker carried out the final examination safely if was inappropriate.
Target sample size
210
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 | Eiji Shimizu |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Cognitive Behavioral Physiology
Zip code
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
Homepage URL
eiji@faculty.chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine Chiba University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 07 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study design
A.A direction of the data acquisition: The kind of the forward ;that but I turn my back and am possible after having obtained consent from a patient when data already exist.
B. study: It is a study of running, a cohort study
Management information
Registered date
| 2017 | Year | 07 | Month | 06 | Day |
Last modified on
| 2017 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032149
