<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/NCT03230955</url>
  </required_header>
  <id_info>
    <org_study_id>061 QUIT_MENTAL PI15/00875</org_study_id>
    <nct_id>NCT03230955</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients</brief_title>
  <acronym>QUITMENTAL</acronym>
  <official_title>Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients: Pragmatic Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Català d'Oncologia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitari de Bellvitge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Vall d'Hebron</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hestia Alliance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut Català d'Oncologia</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>
      Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group&#xD;
      (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance&#xD;
      to quit smoking (including psychological and psycho-educational support and pharmacological&#xD;
      treatment advice, if required) proactively for 12 months, and the CG only brief counselling&#xD;
      after discharge.&#xD;
&#xD;
      To assess the effectiveness of a multicomponent and motivational intensive telephone-based&#xD;
      intervention to stop smoking (&quot;quit line&quot;) addressed to smokers with mental disorders&#xD;
      discharged from hospitals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: People suffering from mental illness are more likely to smoke. In Spain, up to&#xD;
      75% of patients hospitalized for mental disorders smoke, tripling the general population&#xD;
      consumption. Life expectancy for people with severe mental illnesses is decreased by up to 25&#xD;
      years in comparison to the general population, mainly due to diseases caused or worsened by&#xD;
      smoking. Hospitalized patients without monitoring after discharge quickly restore their&#xD;
      tobacco use to previous levels. This evidence suggests the need of an appropriate follow-up&#xD;
      intervention to prevent relapse after discharge and achieve higher rates of withdrawal in&#xD;
      this population.&#xD;
&#xD;
      Objectives: To assess the effectiveness of a multicomponent and motivational intensive&#xD;
      telephone-based intervention to stop smoking (&quot;quit line&quot;) addressed to smokers with mental&#xD;
      disorders discharged from hospitals.&#xD;
&#xD;
      Methods: Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention&#xD;
      Group (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone&#xD;
      assistance to quit smoking (including psychological and psycho-educational support and&#xD;
      pharmacological treatment advice, if required) proactively for 12 months, and the CG only&#xD;
      brief counselling after discharge. The sample size, calculated with an expected difference of&#xD;
      15 points on withdrawal between groups, α=0.05 and β=0.10 and 20% loss, will be of 334 (IG)&#xD;
      and 176 (CG), which will be doubled to allow stratified analyses. Variables: a) dependent&#xD;
      variables: self-reported smoking abstinence and verified by expired carbon monoxide levels,&#xD;
      quit attempts, time of abstinence, motivation and self-efficacy to quit, and b) independent&#xD;
      variables: age, sex and main disorder. Data analysis: multivariate logistic regression (odds&#xD;
      ratio and confidence interval, CI 95%) of abstinence and other variables adjusted for&#xD;
      potential confounding variables. Number of smokers needed to treat (NNT, and its 95% CI) to&#xD;
      achieve one abstinent will be calculated.&#xD;
&#xD;
      Hypothesis: Abstinence rate (≥ 15%) of enrolled patients between groups. If the intervention&#xD;
      is effective, the pragmatic nature of the study will permit to transfer it to the routine&#xD;
      clinical practice with a reasonable investment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</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>
    <intervention_model_description>Participants will be randomized into IG and CG with 2:1 allocation using mapping software, because it is expected a larger number of losses to follow-up in the CG. GI patients will be contacted by a nurse of the 061CatSalut Respon &quot;quit line&quot; who will have received specific training in intervening smokers with mental disorders. The call will take place within the first 48 h after discharge from the hospitals. The patients of the CG will be contacted by a team of the 061 CatSalut Respon in order to provide a brief counselling (first call) and evaluate their use of tobacco during the 1st, 6th and 12th month.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants and hospital clinicians will be blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from tobacco consumption abstinence at 12 months</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Tobacco consumption abstinence (yes/no), self-reported the day of recruitment and 12 months after discharge (7 days abstinence prior to the evaluation point)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the level of self-efficacy to quit smoking</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Change of self reported self-efficacy (using a Likert scale from 0 to 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of motivation to quit smoking (stage of change)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>The Stages of Change Model helps to know the patient's motivation to quit, or stage of change, in order to allow clinicians to tailor interventions according to each stage (Prochaska, 1992).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attempts to quit smoking</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Number of serious quit attempts after discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Mental Disorder</condition>
  <condition>Smoking Cessation</condition>
  <condition>Motivation</condition>
  <arm_group>
    <arm_group_label>Psychological and psycho-educational support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group (IG) [that will receive telephone-based assistance to quit (including psychological and psycho-educational support and pharmacological treatment advice, if required) provided by trained nurses who will proactively call at one week, 15 day, a month, 3, 6 and 12 months after discharge, plus the calls made by the patients during the process]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group (CG) [that will receive only a brief counselling session after discharge]</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychological and psycho-educational support by phone</intervention_name>
    <description>The intervention is based on cognitive-behavioural therapy (CBT). The intervention, in order to achieve behavioural changes, will include components based in Bandura's social learning theory and social cognitive theory (Bandura, 1986) and the transtheorical model of change (Prochaska, 1992). It has been shown that expectations and self-efficacy are behavioural predictors and that they are an effective framework for the assistance to quit smoking. This theory allows evaluating patient motivation phase and adapting the interventions according to each phase (Fiore, 2011)</description>
    <arm_group_label>Psychological and psycho-educational support</arm_group_label>
    <other_name>Telephone-based motivational intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brief counselling session</intervention_name>
    <description>Brief counselling session</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Brief advice</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. smokers;&#xD;
&#xD;
          2. adults of both sexes ≥ 18 years to ≤76 years of age;&#xD;
&#xD;
          3. that have stayed in an Acute or Detoxification mental health unit for more than 24&#xD;
             hours;&#xD;
&#xD;
          4. with a telephone, fixed or mobile;&#xD;
&#xD;
          5. residents in the metropolitan area of Barcelona;&#xD;
&#xD;
          6. that provide their informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patient discharged from the psychiatric emergency room;&#xD;
&#xD;
          2. with dementia or brain damage;&#xD;
&#xD;
          3. that do not speak Spanish or Catalan;&#xD;
&#xD;
          4. pregnant women;&#xD;
&#xD;
          5. with hearing and/or speech deficit;&#xD;
&#xD;
          6. with insufficient reading comprehension skills in Spanish or Catalan;&#xD;
&#xD;
          7. that are trying to quit in smoking in another centre, or using another intervention in&#xD;
             that moment;&#xD;
&#xD;
          8. that have voluntarily requested discharge;&#xD;
&#xD;
          9. that plan to shift their domicile outside of Barcelona county.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cristina Martínez, RN,BA, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Català d'Oncologia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Ballbe M, Martinez C, Salto E, Cabezas C, Riccobene A, Valverde A, Gual A, Fernandez E. Maintenance of tobacco cessation programmes in public hospitals in Catalonia, Spain. Addict Behav. 2015 Mar;42:136-9. doi: 10.1016/j.addbeh.2014.11.028. Epub 2014 Nov 26.</citation>
    <PMID>25462661</PMID>
  </reference>
  <reference>
    <citation>Ballbe M, Nieva G, Mondon S, Pinet C, Bruguera E, Salto E, Fernandez E, Gual A; Smoking and Mental Health Group. Smoke-free policies in psychiatric services: identification of unmet needs. Tob Control. 2012 Nov;21(6):549-54. doi: 10.1136/tobaccocontrol-2011-050029. Epub 2011 Sep 20.</citation>
    <PMID>21933940</PMID>
  </reference>
  <reference>
    <citation>Ballbe M, Sureda X, Martinez-Sanchez JM, Salto E, Gual A, Fernandez E. Second-hand smoke in mental healthcare settings: time to implement total smoke-free bans? Int J Epidemiol. 2013 Jun;42(3):886-93. doi: 10.1093/ije/dyt014. Epub 2013 Mar 29.</citation>
    <PMID>23543600</PMID>
  </reference>
  <reference>
    <citation>Ballbe M, Sureda X, Martinez-Sanchez JM, Fu M, Salto E, Gual A, Fernandez E. Secondhand smoke in psychiatric units: patient and staff misperceptions. Tob Control. 2015 Oct;24(e3):e212-20. doi: 10.1136/tobaccocontrol-2014-051585. Epub 2014 Sep 19.</citation>
    <PMID>25239470</PMID>
  </reference>
  <reference>
    <citation>Banham L, Gilbody S. Smoking cessation in severe mental illness: what works? Addiction. 2010 Jul;105(7):1176-89. doi: 10.1111/j.1360-0443.2010.02946.x. Epub 2010 May 11.</citation>
    <PMID>20491721</PMID>
  </reference>
  <reference>
    <citation>Chabrol H, Niezborala M, Chastan E, de Leon J. Comparison of the Heavy Smoking Index and of the Fagerstrom Test for Nicotine Dependence in a sample of 749 cigarette smokers. Addict Behav. 2005 Aug;30(7):1474-7. doi: 10.1016/j.addbeh.2005.02.001.</citation>
    <PMID>16022945</PMID>
  </reference>
  <reference>
    <citation>Fiore MC, Baker TB. Clinical practice. Treating smokers in the health care setting. N Engl J Med. 2011 Sep 29;365(13):1222-31. doi: 10.1056/NEJMcp1101512.</citation>
    <PMID>21991895</PMID>
  </reference>
  <reference>
    <citation>Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.</citation>
    <PMID>1932883</PMID>
  </reference>
  <reference>
    <citation>Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25. Erratum In: Nicotine Tob Res. 2003 Aug;5(4):603.</citation>
    <PMID>12745503</PMID>
  </reference>
  <reference>
    <citation>Martinez C, Fu M, Martinez-Sanchez JM, Ballbe M, Puig M, Garcia M, Carabasa E, Salto E, Fernandez E. Tobacco control policies in hospitals before and after the implementation of a national smoking ban in Catalonia, Spain. BMC Public Health. 2009 May 28;9:160. doi: 10.1186/1471-2458-9-160.</citation>
    <PMID>19473549</PMID>
  </reference>
  <reference>
    <citation>Martinez C, Guydish J, Le T, Tajima B, Passalacqua E. Predictors of quit attempts among smokers enrolled in substance abuse treatment. Addict Behav. 2015 Jan;40:1-6. doi: 10.1016/j.addbeh.2014.08.005. Epub 2014 Aug 27.</citation>
    <PMID>25218064</PMID>
  </reference>
  <reference>
    <citation>Morris CD, Tedeschi GJ, Waxmonsky JA, May M, Giese AA. Tobacco quitlines and persons with mental illnesses: perspective, practice, and direction. J Am Psychiatr Nurses Assoc. 2009 Feb;15(1):32-40. doi: 10.1177/1078390308330050.</citation>
    <PMID>21665792</PMID>
  </reference>
  <reference>
    <citation>Morris CD, Waxmonsky JA, May MG, Tinkelman DG, Dickinson M, Giese AA. Smoking reduction for persons with mental illnesses: 6-month results from community-based interventions. Community Ment Health J. 2011 Dec;47(6):694-702. doi: 10.1007/s10597-011-9411-z. Epub 2011 May 10.</citation>
    <PMID>21556784</PMID>
  </reference>
  <reference>
    <citation>Prochaska JJ, Hall SE, Delucchi K, Hall SM. Efficacy of initiating tobacco dependence treatment in inpatient psychiatry: a randomized controlled trial. Am J Public Health. 2014 Aug;104(8):1557-65. doi: 10.2105/AJPH.2013.301403. Epub 2013 Aug 15.</citation>
    <PMID>23948001</PMID>
  </reference>
  <reference>
    <citation>Twyman L, Bonevski B, Paul C, Bryant J. Perceived barriers to smoking cessation in selected vulnerable groups: a systematic review of the qualitative and quantitative literature. BMJ Open. 2014 Dec 22;4(12):e006414. doi: 10.1136/bmjopen-2014-006414.</citation>
    <PMID>25534212</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>March 29, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Randomized clinical trial</keyword>
  <keyword>Hotlines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual data will not be shared with other researchers</ipd_description>
  </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/NCT03230955
org study id: 061 QUIT_MENTAL PI15/00875
nct id: NCT03230955
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention Group
      (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone assistance
      to quit smoking (including psychological and psycho-educational support and pharmacological
      treatment advice, if required) proactively for 12 months, and the CG only brief counselling
      after discharge.

      To assess the effectiveness of a multicomponent and motivational intensive telephone-based
      intervention to stop smoking ("quit line") addressed to smokers with mental disorders
      discharged from hospitals.
Background: People suffering from mental illness are more likely to smoke. In Spain, up to
      75% of patients hospitalized for mental disorders smoke, tripling the general population
      consumption. Life expectancy for people with severe mental illnesses is decreased by up to 25
      years in comparison to the general population, mainly due to diseases caused or worsened by
      smoking. Hospitalized patients without monitoring after discharge quickly restore their
      tobacco use to previous levels. This evidence suggests the need of an appropriate follow-up
      intervention to prevent relapse after discharge and achieve higher rates of withdrawal in
      this population.

      Objectives: To assess the effectiveness of a multicomponent and motivational intensive
      telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental
      disorders discharged from hospitals.

      Methods: Pragmatic randomized clinical trial, single-blind, with allocation 2:1 [Intervention
      Group (IG) and control group (CG)] in 5 acute hospitals. The IG will receive telephone
      assistance to quit smoking (including psychological and psycho-educational support and
      pharmacological treatment advice, if required) proactively for 12 months, and the CG only
      brief counselling after discharge. The sample size, calculated with an expected difference of
      15 points on withdrawal between groups, α=0.05 and β=0.10 and 20% loss, will be of 334 (IG)
      and 176 (CG), which will be doubled to allow stratified analyses. Variables: a) dependent
      variables: self-reported smoking abstinence and verified by expired carbon monoxide levels,
      quit attempts, time of abstinence, motivation and self-efficacy to quit, and b) independent
      variables: age, sex and main disorder. Data analysis: multivariate logistic regression (odds
      ratio and confidence interval, CI 95%) of abstinence and other variables adjusted for
      potential confounding variables. Number of smokers needed to treat (NNT, and its 95% CI) to
      achieve one abstinent will be calculated.

      Hypothesis: Abstinence rate (≥ 15%) of enrolled patients between groups. If the intervention
      is effective, the pragmatic nature of the study will permit to transfer it to the routine
      clinical practice with a reasonable investment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized into IG and CG with 2:1 allocation using mapping software, because it is expected a larger number of losses to follow-up in the CG. GI patients will be contacted by a nurse of the 061CatSalut Respon "quit line" who will have received specific training in intervening smokers with mental disorders. The call will take place within the first 48 h after discharge from the hospitals. The patients of the CG will be contacted by a team of the 061 CatSalut Respon in order to provide a brief counselling (first call) and evaluate their use of tobacco during the 1st, 6th and 12th month.
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Participants and hospital clinicians will be blind
measure: Change from tobacco consumption abstinence at 12 months
time frame: through study completion, an average of 1 year
description: Tobacco consumption abstinence (yes/no), self-reported the day of recruitment and 12 months after discharge (7 days abstinence prior to the evaluation point)
measure: Change in the level of self-efficacy to quit smoking
time frame: through study completion, an average of 1 year
description: Change of self reported self-efficacy (using a Likert scale from 0 to 10)
measure: Change of motivation to quit smoking (stage of change)
time frame: through study completion, an average of 1 year
description: The Stages of Change Model helps to know the patient's motivation to quit, or stage of change, in order to allow clinicians to tailor interventions according to each stage (Prochaska, 1992).
measure: Attempts to quit smoking
time frame: through study completion, an average of 1 year
description: Number of serious quit attempts after discharge
arm group label: Psychological and psycho-educational support
arm group type: Experimental
description: The intervention group (IG) [that will receive telephone-based assistance to quit (including psychological and psycho-educational support and pharmacological treatment advice, if required) provided by trained nurses who will proactively call at one week, 15 day, a month, 3, 6 and 12 months after discharge, plus the calls made by the patients during the process]
arm group label: Control Group
arm group type: Active Comparator
description: The control group (CG) [that will receive only a brief counselling session after discharge]
intervention type: Behavioral
intervention name: Psychological and psycho-educational support by phone
description: The intervention is based on cognitive-behavioural therapy (CBT). The intervention, in order to achieve behavioural changes, will include components based in Bandura's social learning theory and social cognitive theory (Bandura, 1986) and the transtheorical model of change (Prochaska, 1992). It has been shown that expectations and self-efficacy are behavioural predictors and that they are an effective framework for the assistance to quit smoking. This theory allows evaluating patient motivation phase and adapting the interventions according to each phase (Fiore, 2011)
arm group label: Psychological and psycho-educational support
other name: Telephone-based motivational intervention
intervention type: Other
intervention name: Brief counselling session
description: Brief counselling session
arm group label: Control Group
other name: Brief advice
criteria: 
gender: All
minimum age: 18 Years
maximum age: 76 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cristina Martínez, RN,BA, PhD
role: Principal Investigator
affiliation: Institut Català d'Oncologia
facility: 
country: Spain
citation: Ballbe M, Martinez C, Salto E, Cabezas C, Riccobene A, Valverde A, Gual A, Fernandez E. Maintenance of tobacco cessation programmes in public hospitals in Catalonia, Spain. Addict Behav. 2015 Mar;42:136-9. doi: 10.1016/j.addbeh.2014.11.028. Epub 2014 Nov 26.
PMID: 25462661
citation: Ballbe M, Nieva G, Mondon S, Pinet C, Bruguera E, Salto E, Fernandez E, Gual A; Smoking and Mental Health Group. Smoke-free policies in psychiatric services: identification of unmet needs. Tob Control. 2012 Nov;21(6):549-54. doi: 10.1136/tobaccocontrol-2011-050029. Epub 2011 Sep 20.
PMID: 21933940
citation: Ballbe M, Sureda X, Martinez-Sanchez JM, Salto E, Gual A, Fernandez E. Second-hand smoke in mental healthcare settings: time to implement total smoke-free bans? Int J Epidemiol. 2013 Jun;42(3):886-93. doi: 10.1093/ije/dyt014. Epub 2013 Mar 29.
PMID: 23543600
citation: Ballbe M, Sureda X, Martinez-Sanchez JM, Fu M, Salto E, Gual A, Fernandez E. Secondhand smoke in psychiatric units: patient and staff misperceptions. Tob Control. 2015 Oct;24(e3):e212-20. doi: 10.1136/tobaccocontrol-2014-051585. Epub 2014 Sep 19.
PMID: 25239470
citation: Banham L, Gilbody S. Smoking cessation in severe mental illness: what works? Addiction. 2010 Jul;105(7):1176-89. doi: 10.1111/j.1360-0443.2010.02946.x. Epub 2010 May 11.
PMID: 20491721
citation: Chabrol H, Niezborala M, Chastan E, de Leon J. Comparison of the Heavy Smoking Index and of the Fagerstrom Test for Nicotine Dependence in a sample of 749 cigarette smokers. Addict Behav. 2005 Aug;30(7):1474-7. doi: 10.1016/j.addbeh.2005.02.001.
PMID: 16022945
citation: Fiore MC, Baker TB. Clinical practice. Treating smokers in the health care setting. N Engl J Med. 2011 Sep 29;365(13):1222-31. doi: 10.1056/NEJMcp1101512.
PMID: 21991895
citation: Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PMID: 1932883
citation: Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25. Erratum In: Nicotine Tob Res. 2003 Aug;5(4):603.
PMID: 12745503
citation: Martinez C, Fu M, Martinez-Sanchez JM, Ballbe M, Puig M, Garcia M, Carabasa E, Salto E, Fernandez E. Tobacco control policies in hospitals before and after the implementation of a national smoking ban in Catalonia, Spain. BMC Public Health. 2009 May 28;9:160. doi: 10.1186/1471-2458-9-160.
PMID: 19473549
citation: Martinez C, Guydish J, Le T, Tajima B, Passalacqua E. Predictors of quit attempts among smokers enrolled in substance abuse treatment. Addict Behav. 2015 Jan;40:1-6. doi: 10.1016/j.addbeh.2014.08.005. Epub 2014 Aug 27.
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PMID: 25534212
responsible party type: Sponsor
mesh term: Mental Disorders
sharing ipd: No
ipd description: Individual data will not be shared with other researchers