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

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 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


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

Value
https://center6.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