UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031527
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kaz-mat@umin.net

Sponsor
Institute Tohoku University, Graduate School of Medicine, Department of Preventive Psychiatry
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035997

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.