title: Effectiveness of a multi-component Smoking Cessation Support Programme (McSCSP) for patients with severe mental disorders: study design.
abstract: Only a few studies have examined the efficacy and safety of smoking cessation programmes in patients with mental disorders. The aim of this paper is to describe in detail the methodology used in the study as well as the Multi-component Smoking Cessation Support Programme in terms of pharmacological treatments and psychological interventions. An open-label 9-month follow-up study was conducted in Spain. A total of 82 clinically stable outpatients with schizophrenia, schizoaffective or bipolar disorder were enrolled. Treatment consisted of a programme specifically developed by the research team for individuals with severe mental disorders. The programme consisted of two phases: (1) weekly individual motivational therapy for 4-12 weeks, and (2) a 12-week active treatment phase. During this phase, at each study visit patients received a one- or two-week supply of medication (transdermal nicotine patches, varenicline or bupropion) with instructions on how to take it, in addition to group psychotherapy for smoking cessation. Evaluations were performed: (1) at the time of enrollment in the study, (2) during the 12-week active treatment phase of the study (weekly for the first 4 weeks and then biweekly), and (3) after the end of this phase (two follow-up assessments at weeks 12 and 24). Evaluations included: (1) smoking history, (2) substance use, (3) psychopathology, (4) adverse events, and (5) laboratory tests. The importance of this study lies in addressing a topical issue often ignored by psychiatrists: the unacceptably high rates of tobacco use in patients with severe mental disorders.
authors.forename: Maria Paz
authors.initials: MP
authors.lastname: Garcia-Portilla
authors.forename: Leticia
authors.initials: L
authors.lastname: Garcia-Alvarez
authors.affiliation: Departmento de Psiquiatría, Universidad de Oviedo, 33006 Oviedo, Spain. frank@uniovi.es.
authors.forename: Pilar Alejandra
authors.initials: PA
authors.lastname: Saiz
authors.forename: Eva
authors.initials: E
authors.lastname: Diaz-Mesa
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Galvan
authors.forename: Fernando
authors.initials: F
authors.lastname: Sarramea
authors.forename: Josefa
authors.initials: J
authors.lastname: Garcia-Blanco
authors.forename: Edorta
authors.initials: E
authors.lastname: Elizagarate
authors.forename: Julio
authors.initials: J
authors.lastname: Bobes
mesh_terms: D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use; D001552:Benzazepines / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000523:psychology*; D016642:Bupropion / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D005500:Follow-Up Studies; D006801:Humans; D062405:Motivational Interviewing; D018722:Nicotinic Agonists / Q000627:therapeutic use; D011615:Psychotherapy, Group; D011810:Quinoxalines / Q000627:therapeutic use; D012565:Schizophrenic Psychology; D012720:Severity of Illness Index; D012907:Smoking / Q000188:drug therapy / Q000523:psychology*; D016540:Smoking Cessation / Q000379:methods*; D061485:Tobacco Use Cessation Devices; D000068580:Varenicline
chemical_list: D018687:Antidepressive Agents, Second-Generation; D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D016642:Bupropion; D000068580:Varenicline