UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033542
Receipt number 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 18:39:35

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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 or person

Institute

Nishikyushu University

Institute

Department

Personal name



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

Value
https://center6.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