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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032367
Receipt No. R000036914
Scientific Title Intervention study to examine the effectiveness of general citizen training program by approach based on cognitive behavioral therapy in disaster affected area
Date of disclosure of the study information 2018/04/25
Last modified on 2018/04/26

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Basic information
Public title Intervention study to examine the effectiveness of general citizen training program by approach based on cognitive behavioral therapy in disaster affected area
Acronym Examination of the effectiveness of approach based on cognitive behavioral therapy in disaster affected area
Scientific Title Intervention study to examine the effectiveness of general citizen training program by approach based on cognitive behavioral therapy in disaster affected area
Scientific Title:Acronym Examination of the effectiveness of approach based on cognitive behavioral therapy in disaster affected area
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to target general citizens in disaster affected areas from primary prevention point of view, to learn basic concepts and skills of cognitive behavioral therapy and to use "Kokoro-No exercise workshop" that can be utilized for stress care in daily life To intervene and verify the effect of the program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Average scores of the following items after the workshop ends.
Self-Efficacy Scale; SES
Key secondary outcomes K6, GHQ30, Automatic Thoughts Questionnaire-Revised; ATQ-R

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Approximately two weeks after the prior explanatory meeting, the workshop program of all four will be implemented in the intervention group first.
It takes 90 minutes each time, once a week, for 4 weeks. Also, set home work every time to learn more experientially.
Interventions/Control_2 Waiting group. After the workshop of the intervention group, the same workshop is also implemented in the waiting group.
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
79 years-old >=
Gender Male and Female
Key inclusion criteria Participants of this study were citizens of Miyagi Prefecture who were affected by the Great East Japan Earthquake and wanted to participate in this workshop, understand the purpose of the research, and obtain cooperation.
Key exclusion criteria 1. Person who is in the hospital to psychiatric medical institutions etc.
2. Persons with severe psychiatric symptoms with psychiatric medical institutions, etc. being interrupted / not treated.
3. Persons who have clear alcohol or substance dependence problems.
4. Persons who have obvious mental retardation.
5. Persons who have a history of organic brain damage (including dementia).
6. Persons who have difficulty understanding Japanese.
Target sample size 124

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 Preventive Psychiatry
Zip code
Address 1-1 Seiryomachi, Aoba ward, Sendai city, Miyagi prefecture
TEL 022-717-8059
Email kaz-mat@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Ikki Ueda
Organization Tohoku Universty Hospital
Division name Department of Psychiatry
Zip code
Address 1-1 Seiryomachi, Aoba ward, Sendai city, Miyagi prefecture
TEL 022-717-7262
Homepage URL
Email u.ik.n.n.a.2226@gmail.com

Sponsor
Institute Department of Psychiatry, Tohoku University Hospital
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 YES
Study ID_1 2017-1-855
Org. issuing International ID_1 Tohoku University Graduate School of Medicine
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 04 Month 25 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
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 21 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
2018 Year 04 Month 24 Day
Last modified on
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036914

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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