Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients
Condition: Mental Disorder; Smoking Cessation; Motivation
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Psychological and psycho-educational support by phone; Brief counselling session
Intervention type(s): Behavioral; Other
Intervention description(s): 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); Brief counselling session
Other intervention name(s): Telephone-based motivational intervention; Brief advice
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.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Randomized clinical trial; Hotlines