Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial

Smoking prevalence has declined over the last decade in developed countries. However, in some vulnerable populations, such as people suffering from mental disorders, the prevalence has not followed this trend [1‐3]. People with mental disorders are more likely to smoke, and the greater number of lifetime psychiatric diagnoses, the greater the probability of smoking [4]. 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]. In addition, these patients start to smoke at an early age, experience higher levels of nicotine dependence, and have more difficulty quitting [7, 8].

The reasons for higher consumption of tobacco among people with mental disorders are not clear. 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 particularly those with schizophrenic diagnoses, smoke to ameliorate their symptoms. However, this hypothesis is increasingly rejected [10, 11].

Tobacco is the cause of death for 48–53% of people with mental illness [12, 13] primarily for cardiovascular and respiratory diseases, cancer, and diabetes [14]. For people with severe mental illness, life expectancy is reduced up to 10–17 years, mainly for illnesses caused or worsened by smoking [15‐17]. The persistent high prevalence of tobacco use within this population highlights how public health and healthcare services have neglected the needs of this disadvantaged population [18]. Historically, tobacco consumption has been considered a “minor problem” among patients with mental disorders; it was believed that these patients were not interested in quitting [19] and even that smoking helped patients control their disorder [20]. Some of these beliefs may be reflected in smoking cessation research. While there have been approximately 9000 smoking cessation trials among general population smokers, there have been only 20 such trials among patients with mental disorders [21]. The few studies that have been done, however, indicate that patients with mental disorders can achieve significant rates of abstinence [20].

Over the last decade, some jurisdictions have implemented cost-effective measures, as proposed by the World Health Organization (WHO), to curb smoking among persons with mental disorders [20]. These measures are mainly policies for smoke-free areas, treatment to quit smoking, and community measures of sustained support to quit [22].

Hospitalization in smoke-free psychiatric centers increases the quality of life in both patients and professionals, and decreases the exposure to second-hand smoke [23]. In addition, such policies increase quit attempts by patients and their expectations of staying abstinent [24, 25]. Only total smoke-free areas completely protect patients from second-hand smoke [26]. In Spain, the tobacco control Law 42/2010 bans smoking in both indoors and outdoors areas of acute hospitals including psychiatric units. This legal framework, which implies abstinence of patients during hospitalization, creates a unique opportunity to promote smoking cessation among patients with mental disorders.

Concerning treatment to quit smoking, the use of self-help materials, telephone advice, and psychological and pharmacological treatments have been shown to be effective [27, 28]. Although interventions to promote smoking cessation among patients with mental disorders aim to achieve abstinence, it is often necessary to first promote motivation to quit [27]. Thus, these patients would be able to make serious attempts to quit smoking when hospitals have trained professionals to respond to their needs and offer them pharmacological and psychological aids [29]. Interventions that combine pharmacological treatment and psychological therapy—primarily cognitive-behavioral psychological treatment—increase the likelihood of tobacco cessation in patients with mental disorders [30‐32]. However, without patient monitoring after discharge, smoking is restored to previous levels in 2 weeks [33, 34]. Only a few clinical trials [21, 35, 36] have demonstrated the efficacy of multicomponent interventions (which included motivational, psychosocial, and pharmacological components) addressed to patients with mental disorders after discharge. In these studies, the intervention group showed higher abstinence rates, more quit attempts, and fewer cigarettes per day as compared to controls [21, 35, 36]. In addition, as shown in the general population, it is likely that patients with a mental disorder who quit smoking also reduce their levels of anxiety, increase their quality of life, and obtain better results in abstinence from other drugs [37].

In relation to community measures, “quitlines” (i.e., telephone counseling) stand out as an effective support in the general population [38]. However, this resource has so far been little used among populations with mental disorders [39]. The few studies conducted with mentally ill patients showed that a quitline intervention combined with nicotine replacement therapy (NRT) slightly but significantly increased 7-day point prevalence abstinence at 6 months follow-up, reduced the number of cigarettes consumed per day, and increased readiness to quit smoking [36, 39].

In Catalonia, the health information and care telephone line “061 CatSalut Respon” provides a free support program to quit smoking, which acts as a quitline. A nursing team, experts in telephone assistance and smoking cessation, provide an individualized intervention to quit smoking through intensive care for 1 year. However, this service has not so far been used for patients with mental disorders. Quitlines may have some advantages over other cessation services, as they can increase access, are less costly than face-to-face visits [38], and offer a solution to the lack of systematic interventions in patients with mental disorders especially after discharge [34, 40]. However, contact with the quitline is usually initiated by the smoker, and is not usually initiated proactively by the treatment provider. Therefore, we propose a pragmatic randomized controlled trial that uses the existing resources of 061 CatSalut Respon to engage patients with mental disorders identified during hospitalization in acute psychiatric hospital units.

The aim of this study is to assess the effectiveness of a telephone-based (quitline) intervention for smoking cessation addressed to smokers with severe mental disorders after discharge from adult inpatient acute units (the 061 QuitMental study). The intervention group (IG) will receive a telephone intervention to quit smoking (including psychological and psychoeducational support and pharmacological treatment advice, if required) proactively for 12 months, and the control group (CG) will receive only brief counseling after discharge.

The specific objectives of the 061 QuitMental study are as follows:

These objectives will be analyzed by comparing the results obtained from the IG and the CG at several time points post discharge: 48 h and 1, 6, and 12 months (Fig. 1).

The hypotheses of this study are the following:

This project arises from the collaboration between the Catalan Institute of Oncology, the Public Health Agency of Catalonia, and the 061 CatSalut Respon program, which is a public telephone service from the National Health System about health topics addressed to all citizens.

Smoking has serious implications for people with severe mental illnesses, mainly in terms of quality of life and mortality but also in economic costs and marginalization. Hospital mental health units are an optimal setting to intervene and promote patient engagement in tobacco cessation treatment [21]. For this reason, it is necessary to offer and improve a variety of interventions to motivate and promote cessation among these patients.

Patients with mental health disorders are usually excluded from smoking cessation trials [20], and consequently there is scarce evidence for the effectiveness of quitlines in this population. As these patients usually have high comorbidity and high smoking dependence, they represent a complex population for smoking cessation intervention. They need more intensive counseling, pharmacological intervention, and longer follow-up support to achieve cessation [20], so there is a need to tailor these strategies to this population [50]. Only a few studies of quitline effectiveness have included mental health patients and, usually, quitline interventions have not been tailored to this population [51]. This is the first randomized trial to test a quitline intervention specifically tailored to the needs of mental health patients that incorporates a long-term follow-up of 1 year, since other studies have performed follow-up periods from 6 to 7 months [52] and with smaller samples [53].

The large sample, together with the long follow-up period, will allow us to perform other subgroup analyses in addition to assessing smoking cessation. The main expected outcome is an increased rate of CO-verified 7-day point prevalence abstinence in the intervention group, as compared with the control group. All smokers, regardless of their level of motivation to quit, will be eligible to participate. Analyses will consider covariates such as psychiatric diagnoses, use of other psychoactive substances, psychological distress, mental illness relapse and rehospitalization, and sociodemographic variables. Other relevant outcomes for comparison will include the level of motivation to quit, number of quit attempts, and level of psychological distress.

There are several potential limitations. In Catalonia, Spain, patients who have high motivation to quit smoking at the time of discharge from acute mental health hospitals are referred to a face-to-face intensive smoking cessation intervention with free pharmacotherapy for smoking cessation. These patients are excluded from our study and, therefore, our sample does not include patients with high motivation to quit smoking. Nonetheless, we will assess all patients who meet the study inclusion criteria and compare demographic, psychiatric, and tobacco use characteristics of those who accept or decline enrollment. Another limitation, derived from the long-term follow up design, is loss to follow-up that could bias follow-up findings. We will perform an attrition analysis comparing characteristics of those followed to those not followed at each time point. In addition, to preserve statistical power needed to observe a 15% difference in the quit rate between conditions, we have increased the baseline sample size to accommodate an anticipated 20% loss to follow-up at 12 months. To increase follow-up data collection, clinicians will collect contact telephone numbers for the participant and at least two family members or caregivers. There is potential for underreporting of smoking status at follow-up. Participants reporting nonsmoking status at follow-up receive a reminder and a clinic appointment to complete exhaled CO testing.

If effective, this intervention could be included in the Catalan Health System and regularly offered to mental health patients who smoke, no matter their motivation to quit. We need to offer a wide range of possibilities to intervene in smoking cessation in this population as their smoking prevalence has not decreased in the last decade (Additional file 2).