<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03029923</url>
  </required_header>
  <id_info>
    <org_study_id>214016</org_study_id>
    <secondary_id>R56HL131711-01A1</secondary_id>
    <nct_id>NCT03029923</nct_id>
  </id_info>
  <brief_title>Integrated Smoking Cessation and Mood Management for ACS Patients</brief_title>
  <acronym>PACES</acronym>
  <official_title>Integrated Smoking Cessation and Mood Management for ACS Patients (PACES Phase IV Vanguard R56 Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The Miriam Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quitting smoking following acute coronary syndrome can reduce mortality up to 50%. However,&#xD;
      depression and smoking are highly co-morbid and depressed mood may interfere with cessation&#xD;
      and independently predicts mortality. Thus, a single, integrated treatment for both smoking&#xD;
      and depression could be highly effective in reducing post-acute coronary syndrome mortality.&#xD;
      Behavioral Activation (BA) is a well established treatment for depression and has recently&#xD;
      shown promise as a treatment for smoking cessation. The investigators systematically&#xD;
      developed an intervention integrating gold standard smoking cessation counseling with&#xD;
      existing BA based mood management techniques for post-ACS smokers; Behavioral Activation&#xD;
      Treatment for Cardiac Smokers (BAT-CS).&#xD;
&#xD;
      Objective: For this R56 the investigators will conduct a vanguard trial to pilot all methods,&#xD;
      materials, and systems for the later fully powered BAT-CS vs. attention control trial. The&#xD;
      investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS&#xD;
      or an attention control (Health and Wellness Education). Both groups will be offered the&#xD;
      nicotine patch if medically safe.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding for this pilot transitioned into funding for a fully powered study.&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Acceptability</measure>
    <time_frame>12 weeks post-Discharge</time_frame>
    <description>Treatment Acceptability as measured by the Client Satisfaction Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Smoking Cessation</measure>
    <time_frame>12 weeks post-Discharge</time_frame>
    <description>7 day point-prevalence abstinence. Biochemically verified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Symptoms</measure>
    <time_frame>12 weeks post-Discharge</time_frame>
    <description>Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Tobacco Use</condition>
  <arm_group>
    <arm_group_label>Smoking Cessation and Mood Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smoking cessation and Health and Wellness</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)</intervention_name>
    <description>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.</description>
    <arm_group_label>Smoking Cessation and Mood Management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking cessation plus Health and Wellness</intervention_name>
    <description>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.</description>
    <arm_group_label>Smoking cessation and Health and Wellness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. hospital inpatients with an ACS diagnosis documented in medical record,&#xD;
&#xD;
          2. smoked 1 or more cigarettes per day before being hospitalized,&#xD;
&#xD;
          3. age of 18-75,&#xD;
&#xD;
          4. English fluency,&#xD;
&#xD;
          5. lives within a 1 hour drive of the admitting hospital and has no plans to move away&#xD;
             from the area for 1 year,&#xD;
&#xD;
          6. willing to consider quitting smoking at discharge,&#xD;
&#xD;
          7. has telephone, and&#xD;
&#xD;
          8. willing to consent to all study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. limited mental competency (i.e., Mini Mental Status Exam score ≤ 23);&#xD;
&#xD;
          2. presence of severe mental illness that would interfere with participation (e.g.,&#xD;
             schizophrenia) or suicidality;&#xD;
&#xD;
          3. expected discharge to hospice; and&#xD;
&#xD;
          4. currently attending counseling for depression or smoking cessation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Miriam Hospital</investigator_affiliation>
    <investigator_full_name>Andrew Busch</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>smoking</keyword>
  <keyword>depression</keyword>
  <keyword>Behavioral Activation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03029923
org study id: 214016
secondary id: R56HL131711-01A1
nct id: NCT03029923
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Treatment Acceptability
time frame: 12 weeks post-Discharge
description: Treatment Acceptability as measured by the Client Satisfaction Questionnaire
measure: Smoking Cessation
time frame: 12 weeks post-Discharge
description: 7 day point-prevalence abstinence. Biochemically verified.
measure: Depression Symptoms
time frame: 12 weeks post-Discharge
description: Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
arm group label: Smoking Cessation and Mood Management
arm group type: Experimental
description: Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.
arm group label: Smoking cessation and Health and Wellness
arm group type: Active Comparator
description: Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.
intervention type: Behavioral
intervention name: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)
description: 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.
arm group label: Smoking Cessation and Mood Management
intervention type: Behavioral
intervention name: Smoking cessation plus Health and Wellness
description: 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.
arm group label: Smoking cessation and Health and Wellness
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Miriam Hospital
investigator full name: Andrew Busch
investigator title: Assistant Professor
mesh term: Acute Coronary Syndrome
sharing ipd: No