Smoking CessationPACESNCT01964898
Post Acute Coronary Event Smoking Study
A study testing Behavioral Activation (BA), Standard Smoking Cessation Counseling and Nicotine patch in people with Smoking Cessation and Acute Coronary Syndrome, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking Cessation, Acute Coronary Syndrome
- What is being tested?
- Behavioral Activation (BA), Standard Smoking Cessation Counseling and Nicotine patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Smoking Cessation and Mood Management for Cardiac Patients
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.
Read the 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.
- Conditions
- Smoking Cessation, Acute Coronary Syndrome
- Being tested
- Behavioral Activation (BA), Standard Smoking Cessation Counseling, Nicotine patch, Printed Self-help materials for Smoking Cessation
- Keywords
- Smoking, Mood Management, Depression, Behavioral Activation, Acute Coronary Syndrome, Myocardial Infarction
- Medical subject headings
- Smoking Cessation, Acute Coronary Syndrome, Smoking, Depression, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation (BA)Behavioural
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 CounselingBehavioural
1 hour of in hospital counseling based on clinical guidelines
Nicotine patchDrug
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 CessationOther
| Study group | Role | What they receive |
|---|---|---|
| BA for cardiac patients who smoke | Experimental | 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. Receives: Behavioral: Behavioral Activation (BA); Behavioral: Standard Smoking Cessation Counseling; Drug: Nicotine patch |
| Standard Care | Active comparator | 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. Receives: Behavioral: Standard Smoking Cessation Counseling; Drug: Nicotine patch; Other: Printed Self-help materials for Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Continuous Abstinence From Smoking Since Discharge
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
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
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Busch, The Miriam Hospital
- Investigators
- Andrew M Busch, Ph.D, Principal investigator, The Miriam Hospital Centers for Behavioral and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964898
- Sponsor's protocol ID
- 5K23HL107391
- Acronym
- PACES
- Status last verified
- Jan 2017
- First submitted
- 15 Oct 2013
- Last updated
- 12 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7.
PubMed 28415979
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Smoking Cessation and Mood Management for Cardiac Patients
- ClinicalTrials.gov ID
- NCT01964898
- Acronym / sponsor ID
- PACES / 5K23HL107391
- Conditions
- Smoking Cessation, Acute Coronary Syndrome
- Keywords
- Smoking, Mood Management, Depression, Behavioral Activation, Acute Coronary Syndrome, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Posted 12 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BA for cardiac patients who smoke | Experimental | Behavioral: Behavioral Activation (BA), Behavioral: Standard Smoking Cessation Counseling, Drug: Nicotine patchBehavioral 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. |
| Standard Care | Active comparator | Behavioral: Standard Smoking Cessation Counseling, Drug: Nicotine patch, Other: Printed Self-help materials for Smoking CessationParticipant 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| 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. | Behavioural | BA for cardiac patients who smoke |
| Standard Smoking Cessation Counseling1 hour of in hospital counseling based on clinical guidelines | Behavioural | BA for cardiac patients who smoke, Standard Care |
| Nicotine patchAn 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD. | Drug | BA for cardiac patients who smoke, Standard Care |
| Printed Self-help materials for Smoking Cessation | Other | Standard Care |
Primary outcome
Smoking Cessation: 7 Day Point Prevalence Abstinence
Time frame: 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
Time frame: 6 months
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
Time to Smoking Relapse
Time frame: 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.
Time to Smoking Lapse
Time frame: 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.
4 secondary outcomes
Depression: 9 Item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to 6 months
Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Time frame: Baseline to 6 months
Positive Affect
Time frame: Baseline to 6 months
Negative Affect
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28415979Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7.
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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.
Andrew M Busch, Ph.D principal investigator
The Miriam Hospital Centers for Behavioral and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation (BA), Standard Smoking Cessation Counseling and Nicotine patch in people with Smoking Cessation and Acute Coronary Syndrome, run by The Miriam Hospital at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 12 Jan 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation: 7 Day Point Prevalence Abstinence (time frame: 6 months). The study lists 4 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 NCT01964898, 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 12 Jan 2017.