Coronary Artery DiseaseNCT05079958
Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation
A study testing cognitive-behavioral education and 12-week brisk walking in people with Coronary Artery Disease and Smoking Cessation, run by Cathay General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Smoking Cessation
- What is being tested?
- cognitive-behavioral education and 12-week brisk walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Oct 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cathay General Hospital
Taipei, 10648
Fang-Chun Wei, +88628082121 ext. 3931, wfc@cgh.org.tw
Yi-Min Lee, +88628082121 ext. 3946, yimin@cgh.org.tw
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Smoking Cessation
- Being tested
- cognitive-behavioral education, 12-week brisk walking
- Keywords
- Coronary artery disease, Trans-theoretical Model, Smoking cessation
- Medical subject headings
- Coronary Artery Disease, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-behavioral educationBehavioural
four-week cognitive-behavioral education course
12-week brisk walkingBehavioural
12-week brisk walking
| Study group | Role | What they receive |
|---|---|---|
| Stage2 - cognitive-behavioral education | Experimental | 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. Receives: Behavioral: cognitive-behavioral education |
| Stage 3- 12-week brisk walking | Experimental | 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. Receives: Behavioral: 12-week brisk walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage3-The change of smoking cessation success rate
smoking cessation success
Measured: 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.
Measured: Before, 4-weeks.
Secondary outcomes (8)
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
Measured: 12-weeks, three-month, and six month
Stage3-The change of lung carbon monoxide concentration
physiological status
Measured: 12-weeks, three-month, and six month
Stage3-The change of heart rate variability
physiological status
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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].
Measured: 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.
Measured: Before, 4-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start30 Oct 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang-Chun Wei, Principal investigator, Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079958
- Sponsor's protocol ID
- CGH-OP108004
- Status last verified
- Sep 2021
- First submitted
- 2 Aug 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28505303
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05079958
- Acronym / sponsor ID
- CGH-OP108004
- Conditions
- Coronary Artery Disease, Smoking Cessation
- Keywords
- Coronary artery disease, Trans-theoretical Model, Smoking cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stage2 - cognitive-behavioral education | Experimental | Behavioral: cognitive-behavioral educationA 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. |
| Stage 3- 12-week brisk walking | Experimental | Behavioral: 12-week brisk walkingSubjects 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive-behavioral educationfour-week cognitive-behavioral education course | Behavioural | Stage2 - cognitive-behavioral education |
| 12-week brisk walking12-week brisk walking | Behavioural | Stage 3- 12-week brisk walking |
Primary outcome
Stage3-The change of smoking cessation success rate
Time frame: 12-weeks, three-month, and six month
smoking cessation success
Stage2-The change of smoking cessation behavior
Time frame: Before, 4-weeks.
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.
8 secondary outcomes
Stage3-The change of Fagerstrom Test for Nicotine Dependence (FTND)
Time frame: 12-weeks, three-month, and six month
Stage3-The change of lung carbon monoxide concentration
Time frame: 12-weeks, three-month, and six month
Stage3-The change of heart rate variability
Time frame: 12-weeks, three-month, and six month
Stage3-The change of smoking withdrawal syndrome
Time frame: 12-weeks, three-month, and six month
Stage3-The change of the Center for Epidemiological Studies -Depression Scales (CESD-10)
Time frame: 12-weeks, three-month, and six month
Stage3-The change of Taiwanese Version of the Brief Resilience Scale
Time frame: 12-weeks, three-month, and six month
Stage2- smoking decision-making
Time frame: Before, 4-weeks.
Stage2- self-efficacy in smoking cessation
Time frame: Before, 4-weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Results publication: PubMed 28505303Abrantes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang-Chun Wei principal investigator
Cathay General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive-behavioral education and 12-week brisk walking in people with Coronary Artery Disease and Smoking Cessation, run by Cathay General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang-Chun Wei (+88627082121 ext. 3931, wfc@cgh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage3-The change of smoking cessation success rate (time frame: 12-weeks, three-month, and six month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.