Acute Coronary Syndrome, Smoking Cessation
Conditions
Keywords
Smoking, Mood Management, Depression, Behavioral Activation, Acute Coronary Syndrome, Myocardial Infarction
Brief summary
Smoking and depressed mood are both predictive of mortality following Acute Coronary Syndrome. However, to date, no counseling treatment has been designed to target smoking cessation and manage mood in this population. This trial will test such a treatment based on Behavioral Activation, an approach that has shown promise as an integrated treatment for smoking and mood management in other populations.
Detailed description
The occurrence of Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) can be conceptualized as a teachable moment, whereby patients may be more receptive to smoking cessation messages. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS hospitalization. Thus, a single, integrated treatment that targets both depressed mood and smoking could be highly effective in reducing post-ACS mortality. Behavioral Activation (BA) may be an ideal treatment for this population as BA can easily integrate both mood and smoking cessation related goals and it focuses on addressing restriction of valued activities, which is common in the post-ACS population. Thus, the overall aim of the current study is test a BA treatment manual that integrates smoking cessation and mood management for post-ACS smokers (Behavioral Activation Treatment for cardiac patients who smoke; BAT-CS). We will conduct an RCT (N=72) comparing BAT-CS (1 in-hospital session and 5-9 post-discharge sessions) to Standard Care (SC; 1 in-hospital session and 5 mailed packets of printed self-help materials). Differences in smoking cessation, depressed mood, and positive affect will be compared between conditions.
Interventions
BEHAVIORALBehavioral Activation (BA)
5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
BEHAVIORALStandard Smoking Cessation Counseling
1 hour of in hospital counseling based on clinical guidelines
DRUGNicotine patch
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
OTHERPrinted Self-help materials for Smoking Cessation
Sponsors
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ACS diagnosis documented in medical record * smoked 3 or more cigarettes per day before being hospitalized * between the ages of 18-75 * fluent in English * regular access to a telephone * lives in the Providence, RI area * willing to strongly consider an attempt to quit smoking at discharge
Exclusion criteria
* limited mental competency (i.e., Mini-Mental Status exam \< 20) * presence of current psychosis, serious mental illness, or suicidality, expectation that patient will not live through 6 month study period * currently regularly attending counseling for depression or smoking cessation and plans to continue after discharge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Smoking Lapse | 6 months | Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. |
| Smoking Cessation: 7 Day Point Prevalence Abstinence | 6 months | No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. |
| Continuous Abstinence From Smoking Since Discharge | 6 months | Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. |
| Time to Smoking Relapse | 6 months | Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression: 9 Item Patient Health Questionnaire (PHQ-9) | Baseline to 6 months | The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance. |
| Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD) | Baseline to 6 months | The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance. |
| Positive Affect | Baseline to 6 months | As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance |
| Negative Affect | Baseline to 6 months | As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance. |
Countries
United States
Participant flow
Pre-assignment details
65 patients were recruited. 1 was found to be ineligible pre-randomization.
Participants by arm
| Arm | Count |
|---|---|
| BA for Cardiac Patients Who Smoke Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. | 28 |
| Standard Care Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines
Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Printed Self-help materials for Smoking Cessation | 31 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not receive the allocated interventi | 2 | 1 |
| Overall Study | ineligible post-randomization | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | BA for Cardiac Patients Who Smoke | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 53.9 Years STANDARD_DEVIATION 11.9 | 57.1 Years STANDARD_DEVIATION 8.3 | 55.6 Years STANDARD_DEVIATION 10.2 |
| Gender Female | 5 Participants | 11 Participants | 16 Participants |
| Gender Male | 23 Participants | 20 Participants | 43 Participants |
| Region of Enrollment United States | 28 participants | 31 participants | 59 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 31 |
| serious Total, serious adverse events | 0 / 28 | 0 / 31 |
Outcome results
Primary
Continuous Abstinence From Smoking Since Discharge
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BA for Cardiac Patients Who Smoke | Continuous Abstinence From Smoking Since Discharge | 0.38 proportion of participants |
| Standard Care | Continuous Abstinence From Smoking Since Discharge | 0.34 proportion of participants |
Primary
Smoking Cessation: 7 Day Point Prevalence Abstinence
No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BA for Cardiac Patients Who Smoke | Smoking Cessation: 7 Day Point Prevalence Abstinence | 0.46 proportion of participants |
| Standard Care | Smoking Cessation: 7 Day Point Prevalence Abstinence | 0.44 proportion of participants |
Primary
Time to Smoking Lapse
Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BA for Cardiac Patients Who Smoke | Time to Smoking Lapse | 62.4 Days | Standard Error 13.8 |
| Standard Care | Time to Smoking Lapse | 31.8 Days | Standard Error 6.5 |
Primary
Time to Smoking Relapse
Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BA for Cardiac Patients Who Smoke | Time to Smoking Relapse | 71.2 Days | Standard Error 17.2 |
| Standard Care | Time to Smoking Relapse | 47.4 Days | Standard Error 8.7 |
Secondary
Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Time frame: Baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BA for Cardiac Patients Who Smoke | Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD) | Adjusted CESD Baseline | 10.36 units on a scale | Standard Error 1.31 |
| BA for Cardiac Patients Who Smoke | Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD) | Adjusted CESD 6 months | 5.57 units on a scale | Standard Error 1.06 |
| Standard Care | Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD) | Adjusted CESD Baseline | 11.72 units on a scale | Standard Error 1.23 |
| Standard Care | Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD) | Adjusted CESD 6 months | 6.93 units on a scale | Standard Error 1.03 |
Secondary
Depression: 9 Item Patient Health Questionnaire (PHQ-9)
The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Time frame: Baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BA for Cardiac Patients Who Smoke | Depression: 9 Item Patient Health Questionnaire (PHQ-9) | Adjusted PHQ-9 Baseline | 6.33 units on a scale | Standard Error 2.1 |
| BA for Cardiac Patients Who Smoke | Depression: 9 Item Patient Health Questionnaire (PHQ-9) | Adjusted PHQ-9 6 months | 3.34 units on a scale | Standard Error 2.62 |
| Standard Care | Depression: 9 Item Patient Health Questionnaire (PHQ-9) | Adjusted PHQ-9 Baseline | 6.98 units on a scale | Standard Error 1.77 |
| Standard Care | Depression: 9 Item Patient Health Questionnaire (PHQ-9) | Adjusted PHQ-9 6 months | 6.08 units on a scale | Standard Error 2.35 |
Secondary
Negative Affect
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
Time frame: Baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BA for Cardiac Patients Who Smoke | Negative Affect | Adjusted PANAS-Negative Baseline | 9.63 units on a scale | Standard Error 0.91 |
| BA for Cardiac Patients Who Smoke | Negative Affect | Adjusted PANAS-Negative 6 months | 7.41 units on a scale | Standard Error 1.41 |
| Standard Care | Negative Affect | Adjusted PANAS-Negative Baseline | 7.62 units on a scale | Standard Error 0.75 |
| Standard Care | Negative Affect | Adjusted PANAS-Negative 6 months | 8.14 units on a scale | Standard Error 0.87 |
Secondary
Positive Affect
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance
Time frame: Baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BA for Cardiac Patients Who Smoke | Positive Affect | Adjusted PANAS-Positive Baseline | 13.47 units on a scale | Standard Error 0.68 |
| BA for Cardiac Patients Who Smoke | Positive Affect | Adjusted PANAS-Positive 6 months | 16.85 units on a scale | Standard Error 1.66 |
| Standard Care | Positive Affect | Adjusted PANAS-Positive Baseline | 14.56 units on a scale | Standard Error 0.47 |
| Standard Care | Positive Affect | Adjusted PANAS-Positive 6 months | 15.79 units on a scale | Standard Error 1.52 |