UMIN-CTR Clinical Trial

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

anxiety disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

eiji@faculty.chiba-u.jp

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

Email

eiji@faculty.chiba-u.jp

Institute

Graduate School of Medicine Chiba University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

07

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

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