UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of cognitive behavioral therapy and brain alteration in post-traumatic stress disorder
Title of the study (Brief title)	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	Eiji Shimizu
Organization	Chiba University
Division name	Department of Cognitive Behavioral Physiology, Graduate School of Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	0432262975
Email	eiji@faculty.chiba-u.jp

Public contact
Name of contact person	Yoshiyuki Hirano
Organization	Chiba University
Division name	Research Center for Child Mental Development
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	0432262975
Homepage URL
Email	hirano@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028517