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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001183
Receipt No. R000001446
Scientific Title Randomized controlled trial on the efficacy of the prolonged exposure therapy for PTSD
Date of disclosure of the study information 2008/06/11
Last modified on 2011/01/16

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Basic information
Public title Randomized controlled trial on the efficacy of the prolonged exposure therapy for PTSD
Acronym RCT of the PE for PTSD
Scientific Title Randomized controlled trial on the efficacy of the prolonged exposure therapy for PTSD
Scientific Title:Acronym RCT of the PE for PTSD
Region
Japan

Condition
Condition Posttraumatic Stress Disorder (PTSD)
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of the prolonged exposure therapy (PE) for PTSD by comparing the outcome of the groups of PE added to treatment as usual (TAU) and TAU alone, with the RCT design and masked assessment of the severity of PTSD symptoms pre and post treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The severity of PTSD symptoms measured by the CAPS
Key secondary outcomes 1.PTSD diagnosis confirmed by the CAPS
2.Psychological symptoms other than PTSD, i.e., STAI, SCL-90R, DES, PTCI, WHOQOL
3.Autonomic nervous function at rest
4.Serum cortisol and stress related hormones

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The prolonged exposure therapy added to the treatment as usual
Interventions/Control_2 treatment as usual
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
16 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria 1.Diagnosed as PTSD by the CAPS with its score greater than 40
2.More than 6 months duration of PTSD
3.PTSD was caused by human violence, such as rape, intimate partner violence, assault etc.
4.Traumatized after the age 15
5.Those who live in the catchment area of the participating centers
6.Those who can spend two hours a day for the homework
7.Native Japanese speaker
Key exclusion criteria 1.Comorbidity of schizophrenia, bipolar disorder, alcohol or drug dependence, group A personality disorder.
2.Presence of psychopathology that needs acute treatment, such as severe depression, self-harm, severe suicidal attempt, etc.
3.Physical disease that may interfere psychological treatment
4.Those who have a history of epilepsy and whose EEG has not been normalized
5.Pregnant
6.Those who have difficulty in understanding the procedure of the study or treatment protocol, due to illiteracy or intellectual problem, etc.
7.Those who have already received psychological treatment based on exposure to trauma, including EMDR
8.Ongoing or scheduled court litigation for which PTSD works favorably (excluding arbitration or litigation for divorce)
9.Suicidal attempts of serious self harm within past six months(self mutilation that needs suture, overdose of drugs that caused loss of consciousness, manipulative self-harm in order to threat others, etc.)
10.Those who are participating in other clinical trial
11.Those who are judged by the screening doctors as inadequate, due to disturbed consciousness, poor treatment compliance, unstable family environment such as ongoing trauma, etc.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Kim
Organization National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name Division of Adult Mental Health
Zip code
Address 4-1-1 Ogawa Higashi Cho, Kodaira, Tokyo, JAPAN
TEL 042-346-1985
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiharu Kim
Organization National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name Department of Adult Mental Health
Zip code
Address 4-1-1 Ogawa Higashi Cho, Kodaira, Tokyo, JAPAN
TEL 042-346-1985
Homepage URL
Email

Sponsor
Institute National Institute of Mental Health, National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Institute of Women's Health, Tokyo Women's Medical University
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
2008 Year 06 Month 11 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
2008 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information As is approved by the UMIN center, the protcol has been registered May, 2008, but due to inevitable technical reasons, appeared on the list 11 June, 2008.

Management information
Registered date
2008 Year 06 Month 11 Day
Last modified on
2011 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001446

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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