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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Smoking Cessation
• Intervention / Treatment: Behavioral: cognitive-behavioral education; Behavioral: 12-week brisk walking

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.

• Study Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang-Chun Wei; Phone Number: 3931 +88627082121; Email: wfc@cgh.org.tw
• Study Contact Backup: Name: Yi-Min Lee; Phone Number: 3946 88627082121; Email: yimin@cgh.org.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 10648
    • Recruiting
    • Cathay General Hospital
    • Contact: Fang-Chun Wei; Phone Number: 3931 +88628082121; Email: wfc@cgh.org.tw
    • Contact: Yi-Min Lee; Phone Number: 3946 +88628082121; Email: yimin@cgh.org.tw
    • Principal Investigator: YEN-PING Tsai
    • Principal Investigator: CHING-YI Huang
    • Principal Investigator: CHIA-YUAN Liu
    • Principal Investigator: Chiu-Ling Tsai
    • Principal Investigator: Ching-Lien Cheng
    • Principal Investigator: Chii Jeng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage2 - cognitive-behavioral education; 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.	Behavioral: cognitive-behavioral education; four-week cognitive-behavioral education course
Experimental: Stage 3- 12-week brisk walking; 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.	Behavioral: 12-week brisk walking; 12-week brisk walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage3-The change of smoking cessation success rate	smoking cessation success	12-weeks, three-month, and six month
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Stage3-The change of lung carbon monoxide concentration	physiological status	12-weeks, three-month, and six month
Stage3-The change of heart rate variability	physiological status	12-weeks, three-month, and six month
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
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
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
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.
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.

Collaborators and Investigators

• Sponsor: Cathay General Hospital
• Investigators: Principal Investigator: Fang-Chun Wei, Cathay General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Coronary artery disease; Smoking cessation; Trans-theoretical Model
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CGH-OP108004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No