UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008750 |
|---|---|
| Receipt number | R000010276 |
| Scientific Title | A randomized study of bibliotherpy for smoking cessation with and without focusing on cognitive elements |
| Date of disclosure of the study information | 2012/08/22 |
| Last modified on | 2023/03/02 10:32:54 |
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Basic information
Public title
A randomized study of bibliotherpy for smoking cessation with and without focusing on cognitive elements
Acronym
A randomized study of bibliotherpy for smoking cessation with and without focusing on cognitive elements
Scientific Title
A randomized study of bibliotherpy for smoking cessation with and without focusing on cognitive elements
Scientific Title:Acronym
A randomized study of bibliotherpy for smoking cessation with and without focusing on cognitive elements
Region
| Japan |
Condition
Condition
smoking
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare bibliotherapy with and without focusing on cognitive elements for smoking cessation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Smoking status
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Provide one bibliotherapy booklet which is focusing on cognitive elements. Follow up one year later.
Interventions/Control_2
Provide one conventional bibliotherapy booklet. Follow up one year later.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Smokers who are expected to be followed up after a year
Key exclusion criteria
Nonsmokers
Smokers who are not expected to be followed up after a year
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Isomura |
Organization
Reset Behavior Research Group
Division name
Director
Zip code
456-0027
Address
Hataya 2-8-1-305 Atsuta-ku Nagoya, Japan 456-0027
TEL
09042316946
tatakeshiisomura@gmail.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Isomura |
Organization
Reset Behavior Research Group
Division name
Director
Zip code
456-0027
Address
Hataya 2-8-1-305 Atsuta-ku Nagoya, Japan 456-0027
TEL
+81(52)6717339
Homepage URL
http://cleanair.air-nifty.com/private/2007/10/post_b0d3.html
takeshiisomura@gmail.com
Sponsor or person
Institute
Reset Behavior Research Group
Institute
Department
Personal name
Funding Source
Organization
Reset Behavior Research Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reset Behavior Research Group
Address
Shinjuku-ku Mimamimoto-cho 4-18-202 Tokyo, Japan
Tel
03-3354-5411
yuruuishishunki@gmail.com
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
| 2012 | Year | 08 | Month | 22 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 02 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 02 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010276
| 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 |
