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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032606
Receipt No. R000037181
Scientific Title Team approach for prevention, treatment, and recovery of PTSD due to violence victimization: Effectiveness of CBT for individual, parent-child, and family.
Date of disclosure of the study information 2018/05/16
Last modified on 2018/05/16

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Basic information
Public title Team approach for prevention, treatment, and recovery of PTSD due to violence victimization: Effectiveness of CBT for individual, parent-child, and family.
Acronym Effectiveness of CBT on PTSD for individual, parent-child, and family
Scientific Title Team approach for prevention, treatment, and recovery of PTSD due to violence victimization: Effectiveness of CBT for individual, parent-child, and family.
Scientific Title:Acronym Effectiveness of CBT on PTSD for individual, parent-child, and family
Region
Japan

Condition
Condition Post traumatic stress disorder
Classification by specialty
Psychosomatic Internal Medicine Psychiatry Nursing
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is to examine the effectiveness of CBT on PTSD for individual, parent-child, and family provided by the PTSD prevention, treatment, and recovery team.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PTSD Diagnosis, Symptoms of PTSD,depression, and dissociation
Child behavioral problems
Parental difficulties and stress
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver Other
Interventions/Control_1 Conduct Prolonged exposure therapy (PE)on individuals, Parent-Child Interaction Therapy(PCIT) on parent and child, and psycho-education on family.
Interventions/Control_2 PE waiting
PCIT waiting
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria PE:
a.Male and Female aged 20 years and over.
b.Suffering PTS symptoms with and without diagnosis of PTSD
c.Remember and tell traumatic experience
d.Willingly participate in this study
e.Primary doctor's agreement
PCIT
a.Parent or caregiver who fosters children from 2 and a half to 7 years of age.
b.Child has behavioral problems including disruptive behaviors.
c.Could continuously comply to this treatment schedule
d.Willingly participate in this study
e.Primary doctor's agreement
Key exclusion criteria PE
a.Have risk of harm self and others compulsively.
b.Have severe self-harm behaviors
c.Have current psychosis
d.Have risk of being revictimization
e.Almost no trauma memory
f.Minor aged under 20 years
g.No agreement of primary doctor

PCIT
a.Children aged under 2 and a half years or 7 years over, and their parents and caregivers.
b.Could not comply the treatment schedule
c.Required to priorities other intervention than PCIT
d.No agreement of primary doctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miyoko Nagae
Organization Nihon Fukushi University
Division name Faculty of Nursing School
Zip code
Address 229 Kawaminamishinden, Ota-machi, Tokai-shi, Aichi-ken 477-0031, JAPAN
TEL 0562-39-3811
Email mnagae1@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Research Ethics Board
Organization Nihon Fukushi University
Division name Research Department
Zip code
Address 229 Kawaminamishinden, Ota-machi, Tokai-shi, Aichi-ken 477-0031, JAPAN
TEL 0562-39-3811
Homepage URL
Email rinri@ml.n-fukushi.ac.jp

Sponsor
Institute Nihon Fukushi University
Institute
Department

Funding Source
Organization Japanese Society for the Promotion of Science
KAKENHI
Grant in Aid for Scientific Research B
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 05 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 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
2018 Year 05 Month 16 Day
Last modified on
2018 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037181

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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