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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name