UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012509 |
|---|---|
| Receipt number | R000014642 |
| Scientific Title | A research of group cognitive behavioral therapy on working for adult patients with developmental disorders |
| Date of disclosure of the study information | 2013/12/06 |
| Last modified on | 2015/06/06 10:05:07 |
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Basic information
Public title
A research of group cognitive behavioral therapy on working for adult patients with developmental disorders
Acronym
A research of group CBT on work for PDD
Scientific Title
A research of group cognitive behavioral therapy on working for adult patients with developmental disorders
Scientific Title:Acronym
A research of group CBT on work for PDD
Region
| Japan |
Condition
Condition
developmental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are aiming to evaluate the effect on work of group cognitive behavioral therapy for the patients with developmental disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SFS and GAF
Key secondary outcomes
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
| Behavior,custom |
Interventions/Control_1
group cognitive behavioral therapy
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients of Chiba University Hospital meeting the criteria below:
18 - 39 years old
Pervasive developmental disorders in ICD-10
needs to participate in work or other social activities
Key exclusion criteria
Either of the below:
F0, F1, F2, or F7 in ICD-10
Other mental disorders uncontrolled
decision of the docter in charge as inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Iyo |
Organization
Chiba University hospital
Division name
Department of Psychiatry
Zip code
Address
Inohana 1-8-1, Chuoh-ku, Chiba-shi
TEL
81432262297
iyom@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Shiina |
Organization
Chiba University Hospital
Division name
Department of Child Psychiatry
Zip code
Address
Inohana 1-8-1, Chuoh-ku, Chiba-shi
TEL
81432262297
Homepage URL
shiina-akihiro@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 12 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 06 | Day |
Last modified on
| 2015 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014642
