UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of the psychological approach, Skills for Psychological Recovery(SPR), in the reconstruction/recovery phase from the disaster
Title of the study (Brief title)	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	Kazunori Matsumoto
Organization	Tohoku University, Graduate School of Medicine
Division name	Department of Psychiatry
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	Kazunori Matsumoto
Organization	Tohoku University, Graduate School of Medicine
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000035997