BackgroundThere is an increased risk of premature death in people with severe mental illness (SMI). Respiratory disorders and cardiovascular disease are leading causes of increased mortality rates in these patients, and tobacco consumption remains the most preventable risk factor involved. Developing new tools to motivate patients towards cessation of smoking is a high priority. Information on the motivational value of giving the lung age and prevention opportunities is unknown in this high-risk population.Methods/designThis article describes in detail a protocol developed to evaluate an intensive motivational tool, based on the individual risks of pulmonary damage and prevention opportunities. It is designed as a randomized, 12-month, follow-up, multicenter study. A minimum of 204 smokers will be included, aged 40 years and older, all of whom are patients diagnosed with either schizophrenia or bipolar disorder (BD). Chronic obstructive pulmonary disease (COPD) will be evaluated using spirometry, and the diagnosis will then be validated by a pneumologist and the lung age estimated. Based on this value, a motivational message about prevention will be issued for the intervention group, which will be reinforced by individualized text messages over a period of 3 months.The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed.DiscussionIn the context of community care, screening and early detection of lung damage could potentially be used, together with mobile technology, in order to produce a prevention message, which may provide patients with SMI with a better chance of quitting smoking.Trial registrationClinicalTrials.gov, ID: NCT03583203. Registered on 11 July 2018.Trial status: recruitment.

BackgroundThis study has two main objectives: to describe the prevalence of undetected chronic obstructive pulmonary disease (COPD) in a clinical sample of smokers with severe mental illness (SMI), and to assess the value of the Tobacco Intensive Motivational Estimated Risk tool, which informs smokers of their respiratory risk and uses brief text messages to reinforce intervention.MethodA multicenter, randomized, open-label, and active-controlled clinical trial, with a 12-month follow-up. Outpatients with schizophrenia (SZ) and bipolar disorder were randomized either to the experimental group—studied by spirometry and informed of their calculated lung age and degree of obstruction (if any)—or to the active control group, who followed the 5 A’s intervention.ResultsThe study sample consisted of 160 patients (71.9% SZ), 78.1% of whom completed the 12-month follow-up. Of the patients who completed the spirometry test, 23.9% showed evidence of COPD (77.8% in moderate or severe stages). TIMER was associated with a significant reduction in tobacco use at week 12 and in the long term, 21.9% of patients reduced consumption and 14.6% at least halved it. At week 48, six patients (7.3%) allocated to the experimental group achieved the seven-day smoking abstinence confirmed by CO (primary outcome in terms of efficacy), compared to three (3.8%) in the control group.ConclusionIn this clinical pilot trial, one in four outpatients with an SMI who smoked had undiagnosed COPD. An intensive intervention tool favors the early detection of COPD and maintains its efficacy to quit smoking, compared with the standard 5 A’s intervention.

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