Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients: Pragmatic Clinical Trial

Conditions
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Mental Disorder, Smoking Cessation, Motivation

Intervention / Treatment
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* Behavioral: Psychological and psycho-educational support by phone
* Other: Brief counselling session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smokers; adults of both sexes ≥ 18 years to ≤76 years of age; that have stayed in an Acute or Detoxification mental health unit for more than 24 hours; with a telephone, fixed or mobile; residents in the metropolitan area of Barcelona; that provide their informed consent. Exclusion Criteria: patient discharged from the psychiatric emergency room; with dementia or brain damage; that do not speak Spanish or Catalan; pregnant women; with hearing and/or speech deficit; with insufficient reading comprehension skills in Spanish or Catalan; that are trying to quit in smoking in another centre, or using another intervention in that moment; that have voluntarily requested discharge; that plan to shift their domicile outside of Barcelona county.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological and psycho-educational support<br>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] | Behavioral: Psychological and psycho-educational support by phone<br>* 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)<br>* Other names: Telephone-based motivational intervention;|
| Active Comparator: Control Group<br>The control group (CG) [that will receive only a brief counselling session after discharge] | Other: Brief counselling session<br>* Brief counselling session<br>* Other names: Brief advice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from tobacco consumption abstinence at 12 months | Tobacco consumption abstinence (yes/no), self-reported the day of recruitment and 12 months after discharge (7 days abstinence prior to the evaluation point) | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the level of self-efficacy to quit smoking | Change of self reported self-efficacy (using a Likert scale from 0 to 10) | through study completion, an average of 1 year | 
| Change of motivation to quit smoking (stage of change) | 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). | through study completion, an average of 1 year | 
| Attempts to quit smoking | Number of serious quit attempts after discharge | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized clinical trial, Hotlines