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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033542
Receipt No. R000038246
Scientific Title Intervention Effects on the Willingness to Stop Smoking and Social Nicotine Dependence Based on Single-session Group Therapy with Frequent Use of Role Play Targeting Smokers with Mental Disorders
Date of disclosure of the study information 2018/07/27
Last modified on 2018/07/27

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Basic information
Public title Intervention Effects on the Willingness to Stop Smoking and Social Nicotine Dependence Based on Single-session Group Therapy with Frequent Use of Role Play Targeting Smokers with Mental Disorders
Acronym Intervention Effects on the Willingness to Stop Smoking and Social Nicotine Dependence Based on Single-session Group Therapy with Frequent Use of Role Play Targeting Smokers with Mental Disorders
Scientific Title Intervention Effects on the Willingness to Stop Smoking and Social Nicotine Dependence Based on Single-session Group Therapy with Frequent Use of Role Play Targeting Smokers with Mental Disorders
Scientific Title:Acronym Intervention Effects on the Willingness to Stop Smoking and Social Nicotine Dependence Based on Single-session Group Therapy with Frequent Use of Role Play Targeting Smokers with Mental Disorders
Region
Japan

Condition
Condition Smokers with Mental Disorders
Classification by specialty
Psychiatry Rehabilitation medicine Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We devised a Smoking Cessation Motivation Program as a community welfare service aimed at making short-term improvements in social nicotine dependence and enhancing the willingness to stop smoking among people with mental disorders. The study conducted a controlled trial to empirically examine the effects of the program on the willingness to stop smoking and social nicotine dependence among smokers with mental disorders in the intervention group, who were compared with a control group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary evaluation item was the Kano Test for Social Nicotine Dependence
Key secondary outcomes Stages of behavioral change
Willingness to quit smoking
Confidence to quit smoking
Confidence to deal with the temptation to smoke

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Smoking-Cessation Motivation Program
Single-session Group Therapy
Interventions/Control_2 A pre-survey was conducted at the facility assigned to the control group, as well as a test to measure exhaled carbon monoxide concentration, and a post-survey was conducted after about an hour of normal activity.
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Adults aged 20 over were targeted. We selected schizophrenic patients interested in quitting smoking who had a GAF of more than 50 points, and had been discharged from a hospital and were living in the community interested in the program at the time of the intervention. A questionnaire was conducted in advance. We selected respondents who stated that they were interested in quitting and scored higher that 0 (have no intention at all of quitting smoking) on a 10cm (want to quit smoking very much) visual analog scale .
Key exclusion criteria Persons who can not concentrate on this program for 60 minutes
Persons with severe mental retardation (IQ 50 or less)
Persons whose acute symptoms such as hallucinations, delusions, acute alcohol symptoms continue
Any person who falls under any of the above even at the discretion of the staff and the business clerical doctor etc is excluded.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Komatsu Youhei
Organization Nishikyushu University
Division name Department of Rehabilitation Sciences
Zip code
Address 4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga-ken 842-8585, Japan
TEL 0952-52-4191
Email komatsuy@nisikyu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Komatsu Youhei
Organization Nishikyushu University
Division name Department of Rehabilitation Sciences
Zip code
Address 4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga-ken 842-8585, Japan
TEL 0952-52-4191
Homepage URL
Email komatsuy@nisikyu-u.ac.jp

Sponsor
Institute Nishikyushu University
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Fukuoka University
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 07 Month 27 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
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 10 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 07 Month 27 Day
Last modified on
2018 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038246

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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