UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention study to examine the effectiveness of general citizen training program by approach based on cognitive behavioral therapy in disaster affected area
Title of the study (Brief title)	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	Kazunori Matsumoto
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Preventive Psychiatry
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	Ikki Ueda
Organization	Tohoku Universty Hospital
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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