Acute Coronary SyndromePACESNCT03029923
Integrated Smoking Cessation and Mood Management for ACS Patients
A study testing Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) and Smoking cessation plus Health and Wellness in people with Acute Coronary Syndrome and Tobacco Use, run by The Miriam Hospital at 1 site in United States.
Trial summary
Quitting smoking following acute coronary syndrome can reduce mortality up to 50%. However, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Tobacco Use
- What is being tested?
- Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) and Smoking cessation plus Health and Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 Dec 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospital inpatients with an ACS diagnosis documented in medical record,
- smoked 1 or more cigarettes per day before being hospitalized,
- age of 18-75,
- English fluency,
- lives within a 1 hour drive of the admitting hospital and has no plans to move away from the area for 1 year,
- willing to consider quitting smoking at discharge,
- has telephone, and
- willing to consent to all study procedures.
Who cannot join
- limited mental competency (i.e., Mini Mental Status Exam score ≤ 23);
- presence of severe mental illness that would interfere with participation (e.g., schizophrenia) or suicidality;
- expected discharge to hospice; and
- currently attending counseling for depression or smoking cessation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Smoking Cessation and Mood Management for ACS Patients (PACES Phase IV Vanguard R56 Trial)
Quitting smoking following acute coronary syndrome can reduce mortality up to 50%. However, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. Thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. Behavioral Activation (BA) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS).
Objective: For this R56 the investigators will conduct a vanguard trial to pilot all methods, materials, and systems for the later fully powered BAT-CS vs. attention control trial. The investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS or an attention control (Health and Wellness Education). Both groups will be offered the nicotine patch if medically safe.
- Conditions
- Acute Coronary Syndrome, Tobacco Use
- Being tested
- Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS), Smoking cessation plus Health and Wellness
- Keywords
- smoking, depression, Behavioral Activation
- Medical subject headings
- Acute Coronary Syndrome, Tobacco Use, Smoking, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)Behavioural
All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared.
Smoking cessation plus Health and WellnessBehavioural
All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared.
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation and Mood Management | Experimental | Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared. Receives: Behavioral: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) |
| Smoking cessation and Health and Wellness | Active comparator | Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared. Receives: Behavioral: Smoking cessation plus Health and Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Acceptability
Treatment Acceptability as measured by the Client Satisfaction Questionnaire
Measured: 12 weeks post-Discharge
Secondary outcomes (2)
Smoking Cessation
7 day point-prevalence abstinence. Biochemically verified.
Measured: 12 weeks post-Discharge
Depression Symptoms
Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Measured: 12 weeks post-Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start1 Feb 2017 (estimated)
- Primary completion1 Oct 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Why it stopped: Funding for this pilot transitioned into funding for a fully powered study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Andrew Busch, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029923
- Sponsor's protocol ID
- 214016
- Other IDs
- R56HL131711-01A1
- Acronym
- PACES
- Status last verified
- Aug 2017
- First submitted
- 20 Jan 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Smoking Cessation and Mood Management for ACS Patients (PACES Phase IV Vanguard R56 Trial)
- ClinicalTrials.gov ID
- NCT03029923
- Acronym / sponsor ID
- PACES / 214016
- Conditions
- Acute Coronary Syndrome, Tobacco Use
- Keywords
- smoking, depression, Behavioral Activation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for this pilot transitioned into funding for a fully powered study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2017 (estimated)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- 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.
Quitting smoking following acute coronary syndrome can reduce mortality up to 50%. However, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. Thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. Behavioral Activation (BA) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS).
Objective: For this R56 the investigators will conduct a vanguard trial to pilot all methods, materials, and systems for the later fully powered BAT-CS vs. attention control trial. The investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS or an attention control (Health and Wellness Education). Both groups will be offered the nicotine patch if medically safe.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation and Mood Management | Experimental | Behavioral: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared. |
| Smoking cessation and Health and Wellness | Active comparator | Behavioral: Smoking cessation plus Health and WellnessParticipants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- hospital inpatients with an ACS diagnosis documented in medical record,
- smoked 1 or more cigarettes per day before being hospitalized,
- age of 18-75,
- English fluency,
- lives within a 1 hour drive of the admitting hospital and has no plans to move away from the area for 1 year,
Key exclusion criteria (4 listed)
- limited mental competency (i.e., Mini Mental Status Exam score ≤ 23);
- presence of severe mental illness that would interfere with participation (e.g., schizophrenia) or suicidality;
- expected discharge to hospice; and
- currently attending counseling for depression or smoking cessation.
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 |
|---|---|---|
| Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared. | Behavioural | Smoking Cessation and Mood Management |
| Smoking cessation plus Health and WellnessAll participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared. | Behavioural | Smoking cessation and Health and Wellness |
Primary outcome
Treatment Acceptability
Time frame: 12 weeks post-Discharge
Treatment Acceptability as measured by the Client Satisfaction Questionnaire
2 secondary outcomes
Smoking Cessation
Time frame: 12 weeks post-Discharge
Depression Symptoms
Time frame: 12 weeks post-Discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) and Smoking cessation plus Health and Wellness in people with Acute Coronary Syndrome and Tobacco Use, 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 8 inclusion and 4 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: withdrawn, as of the sponsor's last update on 29 Aug 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Treatment Acceptability (time frame: 12 weeks post-Discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2017.