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Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation

Primary Purpose

Coronary Artery Disease, Smoking Cessation

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cognitive-behavioral education
12-week brisk walking
Sponsored by
Cathay General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Coronary artery disease, Trans-theoretical Model, Smoking cessation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Those who meet the diagnosis and can perform aerobic exercise after being referred by a physician.
  2. Those who have a clear consciousness and have no mental disorders as recorded in medical records or verbally.
  3. Those who can walk on their own.
  4. Participated in the first or second phase of the study and the smoking cessation phase is in the preparation and action phases

Exclusion Criteria:

  1. Irregular heart rhythm.
  2. Install a heart regulator.
  3. Those who already have regular exercise (3 times a week, 20-30 minutes of physical activity each time).

Sites / Locations

  • Cathay General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stage2 - cognitive-behavioral education

Stage 3- 12-week brisk walking

Arm Description

A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants' smoking cessation behavior, smoking decision-making, and self-efficacy in smoking cessation.

Subjects who are at the "preparation " and "action" stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status.

Outcomes

Primary Outcome Measures

Stage3-The change of smoking cessation success rate
smoking cessation success
Stage2-The change of smoking cessation behavior
Only one question, "Are you currently considering quitting smoking?" The smoking cessation behavior change stage is divided into 5 periods according to the cross-theoretical model, and they are respectively 1. Unintentional period: current smoking, and no smoking cessation will be considered in the next six months. 2. Intent period: currently smoking, but considering quitting in the next six months. 3. Preparation period: currently smoking, and plan to quit smoking within the nearest month. 4. Action period: I have quit smoking, but less than six months. 5. Maintenance period: I have quit smoking for more than six months.

Secondary Outcome Measures

Stage3-The change of Fagerstrom Test for Nicotine Dependence (FTND)
Used the "Fagerstrom Test for Nicotine Dependence" (FTND) translated by Health Promotion Administration, Ministry of Health and Welfare. The content of the scale includes six questions. The total score of the scale is 0-10 points. The higher the score, the higher the nicotine dependence index; the lower than 4 points means the degree of addiction is not high. If you are determined to quit smoking, you will be successful; 4-6 is divided into addiction High degree, need to work hard to quit smoking; 7-10 points nicotine addiction is very high, and professionals are needed to help quit smoking
Stage3-The change of lung carbon monoxide concentration
physiological status
Stage3-The change of heart rate variability
physiological status
Stage3-The change of smoking withdrawal syndrome
We used French Minnesota Nicotine Withdrawal Scale, MNWS to assess smoking addiction and withdrawal symptoms. This Includes 1 craving for smoking and 8 withdrawal symptoms (depressed mood; irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty falling asleep; restless sleep and the urge to smoke). The items are the feelings of those who quit smoking in the past day, and are scored on a scale of 0 to 4. Not at all: 0 points; mild: 1 point; moderate: 2 points; quite severe: 3 points; extremely severe: 4 points. The score includes the smoking craving degree and the eight withdrawal symptoms, which are used to evaluate smoking cessation After the impact, the higher the score, the more severe the withdrawal symptoms.
Stage3-The change of the Center for Epidemiological Studies -Depression Scales (CESD-10)
We used the Center for Epidemiological Studies -Depression Scales (CESD-10). There are a total of 10 questions, measuring the frequency of depression symptoms in the subject within a week. Each item is given a score of 0 to 3, with a total score of 0 to 30. The higher the score, the more severe the depression. When the scale score ≥ 10 points, it indicates that there is a tendency to depression.
Stage3-The change of Taiwanese Version of the Brief Resilience Scale
We used Taiwanese Version of the Brief Resilience Scale (BRS). The scale has 6 items divided into two dimensions: resilience and succumbing. Questions 1, 3, and 5 are positive questions, the measurement aspect is resilience, questions 2, 4, and 6 are negative questions, and the measurement aspect is yield. The scoring method uses Likert's 5-point scoring method, from 1 to 5 points each representing "strongly disagree" to "strongly agree", and the negative questions are scored in reverse. The BRS score calculation method is to calculate the average of the individual scores of the 6 items. The higher the average, the higher the psychological resilience, and vice versa, the lower the psychological resilience.
Stage2- smoking decision-making
This scale was developed by Chia et al (2013). There are 6 questions on the scale, including "benefits" and "costs". The score for the benefit part is 3-15 points, the higher score indicates that smoking is important, which means that smoking can gain benefits, and smoking is actually bad [negative reaction]. The score for the costs part is scored 3-15 points. The higher the score indicates that smoking will pay the price, meaning that it is important not to smoke [positive reaction].
Stage2- self-efficacy in smoking cessation
The self-efficacy in smoking cessation developed by Ou, Li and Yan (2000).It was used to evaluate the confidence of the subjects to not smoke in various situations. There are a total of 14 questions on the scale. The Likert four-point calculation is used. The scoring method is used to answer that I will never smoke (4 points), I may not smoke (3 points), I may smoke (2 points), and I will definitely smoke (1 point). The score ranges from 14 to 56 points. The higher the score, the better the self-efficacy of refusal to smoke.

Full Information

First Posted
August 2, 2021
Last Updated
October 13, 2021
Sponsor
Cathay General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05079958
Brief Title
Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation
Official Title
Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation and Physical and Mental Health in Patients With Coronary Heart Disease: Application of the Transtheoretical Model
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cathay General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patient's smoking behavior and explore the effect of "Cognitive-Behavioral Education Course" and "Exercise Program" on Smoking cessation, physical health, and mental health of smokers with CAD.
Detailed Description
Smoking is a major risk factor of coronary artery disease (CAD) and is responsible for the death of one in three patients with cardiovascular diseases. Smoking cessation is one of the most favorable methods for reducing the risk of cardiovascular diseases; even for patients with a heart disease, quitting smoking can reduce the chance of a relapse of said disease. However, the Health Promotion Administration revealed that among male patients with acute myocardial infarction (AMI), 79.5% had smoked and 35.6% continued to smoke after an episode of AMI. Although previous studies confirmed that health education and exercises can increase smoking cessation rates, patients' lack of motivation to quit smoking has resulted in a failure rate of 65.5%. Therefore, identifying methods to strengthen patients' motivation to quit smoking is a key to successfully achieving smoking cessation. The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patient's smoking behavior and explore the effect of "Cognitive-Behavioral Education Course" and "Exercise Program" on Smoking cessation, physical health, and mental health of smokers with CAD. This study is composed of three stages in three years period, recruiting patients (who meet the selection criteria) from the cardiology department of a medical center in northern Taiwan. For the first stage, a cross-sectional method will be employed to investigate the relationship between smoking status and various physiological and psychological indicators in patients with CAD. For the second stage, subjects who are at the smoking cessation stage of "precontemplation" and "contemplation" will be recruited. A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants' smoking cessation behavior, smoking decision-making, and self-efficacy in smoking cessation. For the third stage, subjects from Stages 1 and 2 who are at the "preparation " and "action" stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status. The primary indicator used for health status evaluation is smoking cessation success rate; the secondary indicators used are physiological status (i.e., nicotine addiction, lung carbon monoxide concentration, heart rate variability, and smoking withdrawal syndrome) and psychological status (i.e., depression and resilience). SPSS for Window 24.0 software will be used in statistical analysis. The type one error is 0.05. In inferences analysis, chi-square test, Pearson correlation coefficient, independent t test, one-way ANOVA and post hoc comparison (scheffe) test will be used to examine the variance among groups. Finally, ANCOVA and GEE mode will be used to test the effectiveness of intervention at stage 1 and stage 2, respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Smoking Cessation
Keywords
Coronary artery disease, Trans-theoretical Model, Smoking cessation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
For the third stage, subjects will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage2 - cognitive-behavioral education
Arm Type
Experimental
Arm Description
A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants' smoking cessation behavior, smoking decision-making, and self-efficacy in smoking cessation.
Arm Title
Stage 3- 12-week brisk walking
Arm Type
Experimental
Arm Description
Subjects who are at the "preparation " and "action" stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants' immediate (short-term), three-month, and six month (long-term) health status.
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behavioral education
Intervention Description
four-week cognitive-behavioral education course
Intervention Type
Behavioral
Intervention Name(s)
12-week brisk walking
Intervention Description
12-week brisk walking
Primary Outcome Measure Information:
Title
Stage3-The change of smoking cessation success rate
Description
smoking cessation success
Time Frame
12-weeks, three-month, and six month
Title
Stage2-The change of smoking cessation behavior
Description
Only one question, "Are you currently considering quitting smoking?" The smoking cessation behavior change stage is divided into 5 periods according to the cross-theoretical model, and they are respectively 1. Unintentional period: current smoking, and no smoking cessation will be considered in the next six months. 2. Intent period: currently smoking, but considering quitting in the next six months. 3. Preparation period: currently smoking, and plan to quit smoking within the nearest month. 4. Action period: I have quit smoking, but less than six months. 5. Maintenance period: I have quit smoking for more than six months.
Time Frame
Before, 4-weeks.
Secondary Outcome Measure Information:
Title
Stage3-The change of Fagerstrom Test for Nicotine Dependence (FTND)
Description
Used the "Fagerstrom Test for Nicotine Dependence" (FTND) translated by Health Promotion Administration, Ministry of Health and Welfare. The content of the scale includes six questions. The total score of the scale is 0-10 points. The higher the score, the higher the nicotine dependence index; the lower than 4 points means the degree of addiction is not high. If you are determined to quit smoking, you will be successful; 4-6 is divided into addiction High degree, need to work hard to quit smoking; 7-10 points nicotine addiction is very high, and professionals are needed to help quit smoking
Time Frame
12-weeks, three-month, and six month
Title
Stage3-The change of lung carbon monoxide concentration
Description
physiological status
Time Frame
12-weeks, three-month, and six month
Title
Stage3-The change of heart rate variability
Description
physiological status
Time Frame
12-weeks, three-month, and six month
Title
Stage3-The change of smoking withdrawal syndrome
Description
We used French Minnesota Nicotine Withdrawal Scale, MNWS to assess smoking addiction and withdrawal symptoms. This Includes 1 craving for smoking and 8 withdrawal symptoms (depressed mood; irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty falling asleep; restless sleep and the urge to smoke). The items are the feelings of those who quit smoking in the past day, and are scored on a scale of 0 to 4. Not at all: 0 points; mild: 1 point; moderate: 2 points; quite severe: 3 points; extremely severe: 4 points. The score includes the smoking craving degree and the eight withdrawal symptoms, which are used to evaluate smoking cessation After the impact, the higher the score, the more severe the withdrawal symptoms.
Time Frame
12-weeks, three-month, and six month
Title
Stage3-The change of the Center for Epidemiological Studies -Depression Scales (CESD-10)
Description
We used the Center for Epidemiological Studies -Depression Scales (CESD-10). There are a total of 10 questions, measuring the frequency of depression symptoms in the subject within a week. Each item is given a score of 0 to 3, with a total score of 0 to 30. The higher the score, the more severe the depression. When the scale score ≥ 10 points, it indicates that there is a tendency to depression.
Time Frame
12-weeks, three-month, and six month
Title
Stage3-The change of Taiwanese Version of the Brief Resilience Scale
Description
We used Taiwanese Version of the Brief Resilience Scale (BRS). The scale has 6 items divided into two dimensions: resilience and succumbing. Questions 1, 3, and 5 are positive questions, the measurement aspect is resilience, questions 2, 4, and 6 are negative questions, and the measurement aspect is yield. The scoring method uses Likert's 5-point scoring method, from 1 to 5 points each representing "strongly disagree" to "strongly agree", and the negative questions are scored in reverse. The BRS score calculation method is to calculate the average of the individual scores of the 6 items. The higher the average, the higher the psychological resilience, and vice versa, the lower the psychological resilience.
Time Frame
12-weeks, three-month, and six month
Title
Stage2- smoking decision-making
Description
This scale was developed by Chia et al (2013). There are 6 questions on the scale, including "benefits" and "costs". The score for the benefit part is 3-15 points, the higher score indicates that smoking is important, which means that smoking can gain benefits, and smoking is actually bad [negative reaction]. The score for the costs part is scored 3-15 points. The higher the score indicates that smoking will pay the price, meaning that it is important not to smoke [positive reaction].
Time Frame
Before, 4-weeks.
Title
Stage2- self-efficacy in smoking cessation
Description
The self-efficacy in smoking cessation developed by Ou, Li and Yan (2000).It was used to evaluate the confidence of the subjects to not smoke in various situations. There are a total of 14 questions on the scale. The Likert four-point calculation is used. The scoring method is used to answer that I will never smoke (4 points), I may not smoke (3 points), I may smoke (2 points), and I will definitely smoke (1 point). The score ranges from 14 to 56 points. The higher the score, the better the self-efficacy of refusal to smoke.
Time Frame
Before, 4-weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Those who meet the diagnosis and can perform aerobic exercise after being referred by a physician. Those who have a clear consciousness and have no mental disorders as recorded in medical records or verbally. Those who can walk on their own. Participated in the first or second phase of the study and the smoking cessation phase is in the preparation and action phases Exclusion Criteria: Irregular heart rhythm. Install a heart regulator. Those who already have regular exercise (3 times a week, 20-30 minutes of physical activity each time).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang-Chun Wei
Phone
+88627082121
Ext
3931
Email
wfc@cgh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Min Lee
Phone
88627082121
Ext
3946
Email
yimin@cgh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang-Chun Wei
Organizational Affiliation
Cathay General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cathay General Hospital
City
Taipei
ZIP/Postal Code
10648
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang-Chun Wei
Phone
+88628082121
Ext
3931
Email
wfc@cgh.org.tw
First Name & Middle Initial & Last Name & Degree
Yi-Min Lee
Phone
+88628082121
Ext
3946
Email
yimin@cgh.org.tw
First Name & Middle Initial & Last Name & Degree
YEN-PING Tsai
First Name & Middle Initial & Last Name & Degree
CHING-YI Huang
First Name & Middle Initial & Last Name & Degree
CHIA-YUAN Liu
First Name & Middle Initial & Last Name & Degree
Chiu-Ling Tsai
First Name & Middle Initial & Last Name & Degree
Ching-Lien Cheng
First Name & Middle Initial & Last Name & Degree
Chii Jeng
First Name & Middle Initial & Last Name & Degree
Chi-Hung Huang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28505303
Citation
Abrantes AM, Farris SG, Minami H, Strong DR, Riebe D, Brown RA. Acute Effects of Aerobic Exercise on Affect and Smoking Craving in the Weeks Before and After a Cessation Attempt. Nicotine Tob Res. 2018 Apr 2;20(5):575-582. doi: 10.1093/ntr/ntx104.
Results Reference
result

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Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation

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