UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031527 |
|---|---|
| Receipt number | R000035997 |
| Scientific Title | A feasibility study of the psychological approach, Skills for Psychological Recovery(SPR), in the reconstruction/recovery phase from the disaster |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2019/03/04 15:25:33 |
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Basic information
Public title
A feasibility study of the psychological approach, Skills for Psychological Recovery(SPR), in the reconstruction/recovery phase from the disaster
Acronym
A feasibility study of the Skills for Psychological Recovery(SPR)
Scientific Title
A feasibility study of the psychological approach, Skills for Psychological Recovery(SPR), in the reconstruction/recovery phase from the disaster
Scientific Title:Acronym
A feasibility study of the Skills for Psychological Recovery(SPR)
Region
| Japan |
Condition
Condition
post-traumatic stress
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the feasibility of the Skills of Psychological Recovery(SPR), which is the psychological approach recommended for the survivors in the recover/reconstruction phase from the disaster.
In this study, the SPR program will be provided to the survivors of the Great East Japan Earthquake.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental health state: General Health Questionnaire (GHQ-30)
(pre, post, follow-up: 2 months after)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The mental health workers received the training of the SPR (public health nurse, nurse, clinical psychologist psychiatric social worker, psychiatrist, etc) will visit and make an intervention based on the SPR program.
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
1) Over 18 years old
2) A person who is aware of mental unhealthy (more than 7 points in the GHQ-30 total score)
3) A person who live or work in Miyagi prefecture
4) Japanese is the mother tongue
5) A person who is able to understand the purpose and content of this study and to decide and write the consent of participation to the this study
Key exclusion criteria
1) A person who visit regularly to a medical institution, such as a psychiatry clinic/hospital
2) A person whom the treatment is interrupted/untreated and who has severe mental symptoms
3) A person who has remarkable suicide thoughts or high-risk behaviors related to the suicide
4) A person who has the alcohol/substance use disorders
5) A person who has the intellectual disabilities
6) A person who has a history of the organic brain damage, including the dementia
7) A person who is difficult to understand Japanese
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Matsumoto |
Organization
Tohoku University, Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-8059
kaz-mat@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Matsumoto |
Organization
Tohoku University, Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-8059
Homepage URL
kaz-mat@umin.net
Sponsor or person
Institute
Tohoku University, Graduate School of Medicine, Department of Preventive Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Miyagi prefecture
Organization
Division
Category of Funding Organization
Local Government
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 | 03 | Month | 01 | 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
| 2013 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 14 | Day |
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035997
