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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008724
Receipt No. R000009972
Scientific Title Japanese Anxiety Children/Adolescents CBT study
Date of disclosure of the study information 2012/08/27
Last modified on 2018/06/04

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Basic information
Public title Japanese Anxiety Children/Adolescents CBT study
Acronym JACACBT study
Scientific Title Japanese Anxiety Children/Adolescents CBT study
Scientific Title:Acronym JACACBT study
Region
Japan

Condition
Condition social phobia, generalized anxiety disorder, separation anxiety disorder, specific phobia
Classification by specialty
Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate CBT for Japanese children and adolescents with anxiety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Anxiety Disorders Interview Schedule for DSM-IV(ADIS)
Key secondary outcomes Spence Children's Anxiety Scale(SCAS), Depression Self-Rating Scale for Children(DSRS), Children's Cognitive Error Scale(CCES), Children's Self-Statement Scale(CSSS), Spence Children's Scale for Parents(SCAS-P)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 cognitive behavioral intervention
Interventions/Control_2 control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
7 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria To be included in the study the participants(a)have to be between 7 and 18years of age, (b)have an anxiety disorder as determined through a diagnostic interview(ADIS), and (c) agree to discontinue other forms of psychotherapy for the duration of the study.
Key exclusion criteria not fulfill criteria for PTSD, mental retardation, pervasive developmental disorder or a psychotic disorder.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyasu Motomura
Organization Osaka Medical College
Division name Faculty of Nursing
Zip code
Address 7-6, Hacchou-nishimachi, Takatsuki, Osaka
TEL 072-684-7267
Email motomura@art.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoyasu Motomura
Organization Osaka Medical College
Division name Faculty of Nursing
Zip code
Address 7-6, Hacchou-nishimachi, Takatsuki, Osaka
TEL 072-684-7267
Homepage URL
Email nrs105@art.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministry of Health
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪医科大学(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 27 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 Enrolling by invitation
Date of protocol fixation
2012 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 20 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 05 Month 31 Day
Date analysis concluded
2017 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 20 Day
Last modified on
2018 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009972


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