Clinical trial NCT05079958: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Smoking Cessation
Keywords: Coronary artery disease
Trans-theoretical Model
Smoking cessation
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 172
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Stage3-The change of smoking cessation success rate
timeFrame: 12-weeks, three-month, and six month
measure: Stage2-The change of smoking cessation behavior
timeFrame: Before, 4-weeks.
Secondary outcomes:
measure: Stage3-The change of Fagerstrom Test for Nicotine Dependence (FTND)
timeFrame: 12-weeks, three-month, and six month
measure: Stage3-The change of lung carbon monoxide concentration
timeFrame: 12-weeks, three-month, and six month
measure: Stage3-The change of heart rate variability
timeFrame: 12-weeks, three-month, and six month
measure: Stage3-The change of smoking withdrawal syndrome
timeFrame: 12-weeks, three-month, and six month
measure: Stage3-The change of the Center for Epidemiological Studies -Depression Scales (CESD-10)
timeFrame: 12-weeks, three-month, and six month
measure: Stage3-The change of Taiwanese Version of the Brief Resilience Scale
timeFrame: 12-weeks, three-month, and six month
measure: Stage2- smoking decision-making
timeFrame: Before, 4-weeks.
measure: Stage2- self-efficacy in smoking cessation
timeFrame: Before, 4-weeks.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
affiliation: Cathay General Hospital
name: Fang-Chun Wei
role: PRINCIPAL_INVESTIGATOR
References:
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.