UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032367 |
|---|---|
| Receipt number | 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 09:03:55 |
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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
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
u.ik.n.n.a.2226@gmail.com
Sponsor or person
Institute
Department of Psychiatry, Tohoku University Hospital
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036914
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
