Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk - TIMER-): study protocol for a randomized controlled trial

María José Jaén-Moreno, Nuria Feu, Justa Redondo-Écija, Francisco Javier Montiel, Cristina Gómez, Gloria I Del Pozo, Jose Ángel Alcalá, Luis Gutiérrez-Rojas, Vicente Balanzá-Martinez, Geli Marie Chauca, Laura Carrión, Maria Isabel Osuna, María Dolores Sánchez, Inmaculada Caro, Miriam Ayora, Francisca Valdivia, María Soledad López, Jose Manuel Poyato, Fernando Sarramea, María José Jaén-Moreno, Nuria Feu, Justa Redondo-Écija, Francisco Javier Montiel, Cristina Gómez, Gloria I Del Pozo, Jose Ángel Alcalá, Luis Gutiérrez-Rojas, Vicente Balanzá-Martinez, Geli Marie Chauca, Laura Carrión, Maria Isabel Osuna, María Dolores Sánchez, Inmaculada Caro, Miriam Ayora, Francisca Valdivia, María Soledad López, Jose Manuel Poyato, Fernando Sarramea

Abstract

Background: There 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/design: This 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.

Discussion: In 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 registration: ClinicalTrials.gov, ID: NCT03583203 . Registered on 11 July 2018. Trial status: recruitment.

Keywords: Bipolar disorder; Chronic obstructive pulmonary disease; Mobile technology; Schizophrenia; Screening; Tobacco cessation.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol has been approved by the Ethics Committee of Reina Sofía Hospital in Córdoba, Spain, and informed consent will be obtained from each participating patient before recruitment.

Consent for publication

Not applicable.

Competing interests

VB-M. has received grants and served as consultant, advisor or continuing medical education (CME) speaker during the last 5 years for the following entities: Angelini Spain, Angelini Portugal, AstraZeneca, Bristol-Myers-Squibb, Ferrer, Janssen. Juste, Lundbeck, Nutrición Médica, and Otsuka. JA Alcalá-Partera has served as advisor to: Adamed, Lundbeck, Otsuka, Janssen-Cilag, Pfizer, Rovi y Servier; and as speaker to: Janssen-Cilag, Pfizer y Servier. L. Gutiérrez-Rojas has been a spokesperson for, and advisory board member of, Bristol-Myers Squibb, Janssen-Cilag, Astra-Zeneca, Rovi, Lundbeck, Otsuka, GSK and Pfizer. All other researchers report no biomedical financial interests or potential conflicts of interests.

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Figures

Fig. 1
Fig. 1
Flow diagram of study design
Fig. 2
Fig. 2
Scheduled tasks

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