UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032606 |
|---|---|
| Receipt number | 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 01:34:00 |
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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
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
rinri@ml.n-fukushi.ac.jp
Sponsor or person
Institute
Nihon Fukushi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037181
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
