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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05079958
• Other study ID #: CGH-OP108004
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Cathay General Hospital
• Contact: Fang-Chun Wei
• Phone: +88627082121
• Email: wfc[@]cgh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Smoking Cessation

Intervention

Behavioral:
• cognitive-behavioral education
four-week cognitive-behavioral education course
• 12-week brisk walking
12-week brisk walking

Locations

Country	Name	City	State
Taiwan	Cathay General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Cathay General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage3-The change of smoking cessation success rate	smoking cessation success	12-weeks, three-month, and six month
Primary	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.	Before, 4-weeks.
Secondary	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	12-weeks, three-month, and six month
Secondary	Stage3-The change of lung carbon monoxide concentration	physiological status	12-weeks, three-month, and six month
Secondary	Stage3-The change of heart rate variability	physiological status	12-weeks, three-month, and six month
Secondary	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.	12-weeks, three-month, and six month
Secondary	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.	12-weeks, three-month, and six month
Secondary	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.	12-weeks, three-month, and six month
Secondary	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].	Before, 4-weeks.
Secondary	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.	Before, 4-weeks.