UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024791 |
|---|---|
| Receipt number | R000028517 |
| Scientific Title | Effect of cognitive behavioral therapy and brain alteration in post-traumatic stress disorder |
| Date of disclosure of the study information | 2016/11/10 |
| Last modified on | 2017/05/12 11:30:17 |
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Basic information
Public title
Effect of cognitive behavioral therapy and brain alteration in post-traumatic stress disorder
Acronym
Effect of CBT and MRI change in PTSD
Scientific Title
Effect of cognitive behavioral therapy and brain alteration in post-traumatic stress disorder
Scientific Title:Acronym
Effect of CBT and MRI change in PTSD
Region
| Japan |
Condition
Condition
post-traumatic stress disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of cognitive behavioral therapy (prolonged exposure: PE) in post-traumatic stress disorder induced by sexual violent and explore biological indicator brain alteration using MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CAPS, IES-R, PTCI, SF-36
Key secondary outcomes
CES-D, structural and functional MRI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cognitive behavioral therapy (prolonged exposure: PE, 10-15 weekly 120-minite session).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To meet the diagnostic criteria for PTSD induced by sexual violence who remains moderate or severe symptoms (IES-R>=25).
Key exclusion criteria
Individuals who have history of organic disease in the brain, schizophrenia, or other psychiatric disorder.
Individuals who have histories of alcoholic or substance abuse within 12 months.
Individuals who have active suicidality.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Shimizu |
Organization
Chiba University
Division name
Department of Cognitive Behavioral Physiology, Graduate School of Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432262975
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Hirano |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432262975
Homepage URL
hirano@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
| 2016 | Year | 11 | Month | 10 | 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
| 2015 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | 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 | 11 | Month | 10 | Day |
Last modified on
| 2017 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028517
