UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Komatsu Youhei
Organization	Nishikyushu University
Division name	Department of Rehabilitation Sciences
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	Komatsu Youhei
Organization	Nishikyushu University
Division name	Department of Rehabilitation Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 01 Day
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

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Publication of results	Unpublished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