UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018354 |
|---|---|
| Receipt number | R000021250 |
| Scientific Title | Research on a brief psycho-edcuation program for women with post-traumatic disorder |
| Date of disclosure of the study information | 2015/07/20 |
| Last modified on | 2015/07/20 11:45:06 |
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Basic information
Public title
Research on a brief psycho-edcuation program for women with post-traumatic disorder
Acronym
Research on a brief psycho-education for women with PTSD
Scientific Title
Research on a brief psycho-edcuation program for women with post-traumatic disorder
Scientific Title:Acronym
Research on a brief psycho-education for women with 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 effectiveness of the brief psycho-education progaram based on behavior therapy for women with post-traumatic stress disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese-Language Version of the Impact of Event Scale-Reviesed (IES-R): avoidance
Key secondary outcomes
"Total score", "intrusion", and "hyperarousal" of the IES-R
The Japanese version of the Kessler-6 (K6)
The Japanese Version of the WHO Well-Being Index (WHO-5)
"Total score", "parent domain", and "child domain" of the PSI-SF
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A brief psycho-education program based on behavior therapy for women with PTSD
Interventions/Control_2
A psycho-education program for noticing children's early signs of mental health problems
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
Female
Key inclusion criteria
1.Mothers whose children have been participating into the cohoft study "the Great East Japan Earthquake Follow-up for Children"
2.Mothers have been suffered from PTSD's avoidance symptoms
3.Mothers' avoidance things are those which they had to be often exposure in daily life
4.Mothers can perform imaginary exposure exercise and had no severe psychological reactions in the first interviews
Key exclusion criteria
1. Mothers have been suffered from severe PTSD symtptoms
2. Mothers have been suffered from major deprssion diagnosed DSM-4-TR
3. Mothers have been treated in psychiatric hospitals
4. Mothers are thought that they can have side effects with this intervention program because of vulnerable ego function
5. Mothers have suicied attempts
6. Mothers had maltreatment or child abuses with their children
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Tachibana |
Organization
National Center for Child Health and Development
Division name
Division of Infant and Toddler Mental Healath, Department of Psychosocial Medicine
Zip code
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
+81-(0)3-3416-0181
tachibana-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Tachibana |
Organization
National Center for Child Health and Development
Division name
Division of Infant and Toddler Mental Healath, Department of Psychosocial Medicine
Zip code
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
+81-(0)3-3416-0181
Homepage URL
tachibana-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 07 | Month | 20 | 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
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 26 | 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
| 2015 | Year | 07 | Month | 20 | Day |
Last modified on
| 2015 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021250
| 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 |
