Abstract
BackgroundUp to 75% of inpatients with mental disorders smoke, and their life expectancy is decreased by up to 25 years compared to the general population. Hospitalized patients without monitoring after discharge quickly return to prehospitalization levels of tobacco use. The aim of the 061 QuitMental study is to assess the effectiveness of a multicomponent and motivational telephone-based intervention to stop smoking through a quitline addressed to smokers discharged from mental health hospital wards.MethodsA pragmatic randomized controlled trial, single blinded, will include 2:1 allocation to the intervention group (IG) and the control group (CG). The IG will receive telephone assistance to quit smoking (including psychological and psychoeducational support, and pharmacological treatment advice if required) proactively for 12 months, and the CG will receive only brief advice after discharge. The sample size, calculated with an expected difference of 15 points on smoking abstinence between groups (IG, 20% and CG, 5%), α = 0.05, β = 0.10, and 20% loss, will be 334 participants (IG) and 176 participants (CG). Participants are adult smokers discharged from psychiatric units of five acute hospitals.Measurements include dependent variables (self-reported 7-day point prevalence smoking abstinence (carbon monoxide verified), duration of abstinence, number of quit attempts, motivation, and self-efficacy to quit) and independent variables (age, sex, and psychiatric diagnoses). In data analysis, IG and CG data will be compared at 48 h and 1, 6, and 12 months post discharge. Multivariate logistic regression (odds ratio; 95% confidence interval) of dependent variables adjusted for potential confounding variables will be performed. The number needed to treat to achieve one abstinence outcome will be calculated. We will compare the abstinence rate of enrolled patients between groups.DiscussionThis trial evaluates an innovative format of a quitline for smokers with severe mental disorders regardless of their motivation to quit. If effective, the pragmatic nature of the study will permit transfer to routine clinical practice in the National Health System.Trial registrationClinicalTrials.gov, NCT03230955. Registered on 24 July 2017.
Highlights
Up to 75% of inpatients with mental disorders smoke, and their life expectancy is decreased by up to 25 years compared to the general population
Ballbè et al Trials (2019) 20:38 (Continued from previous page). This trial evaluates an innovative format of a quitline for smokers with severe mental disorders regardless of their motivation to quit
Patients with mental health disorders are usually excluded from smoking cessation trials [20], and there is scarce evidence for the effectiveness of quitlines in this population
Summary
Up to 75% of inpatients with mental disorders smoke, and their life expectancy is decreased by up to 25 years compared to the general population. In Catalonia, 74.4% of patients hospitalized for mental disorders smoke [5], which is three times higher than the smoking rate (26.9%) in the general population [6]. Several explanations have been suggested, including genetic factors or/ and a low socioeconomic level [9] Another explanation sometimes invoked is the self-medication hypothesis, which suggests that patients with mental disorders, and those with schizophrenic diagnoses, smoke to ameliorate their symptoms. This hypothesis is increasingly rejected [10, 11]
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