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

Background 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. Hospitalized patients without monitoring after discharge quickly return to prehospitalization levels of tobacco use. The aim of the 061 QuitMen...

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Autores: Ballbè, Montse, Martínez Martínez, Cristina, Feliu, Ariadna, Torres, Núria, Nieva, Gemma, Pinet, Cristina, Raich, Antònia, Mondon, Sílvia, Barrio, Pablo, Hernández-Ribas, Rosa, Vicens, Jordi, Costa, Sílvia, Vilaplana Mayoral, Jordi, Alaustre, Laura, Vilalta, Eva, Blanch, Roser, Subirà, Susana, Bruguera, Eugeni, Suelves, Josep Maria, Guydish, Joseph, Fernández, Esteve
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10459.1/65821
Acceso en línea:https://doi.org/10.1186/s13063-018-3106-5
http://hdl.handle.net/10459.1/65821
Access Level:acceso abierto
Palabra clave:Mental disorders
Clinical trial
Smoking cessation
Telephone
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spelling Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trialBallbè, MontseMartínez Martínez, CristinaFeliu, AriadnaTorres, NúriaNieva, GemmaPinet, CristinaRaich, AntòniaMondon, SílviaBarrio, PabloHernández-Ribas, RosaVicens, JordiCosta, SílviaVilaplana Mayoral, JordiAlaustre, LauraVilalta, EvaBlanch, RoserSubirà, SusanaBruguera, EugeniSuelves, Josep MariaGuydish, JosephFernández, EsteveMental disordersClinical trialSmoking cessationTelephoneBackground 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. 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. Methods A 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. Discussion This 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 SystemThis study has been funded by the Instituto Carlos III (ISCIII) (Grant: PI15/00875) Fondo Europeo de Desarrollo Regional (FEDER) “Una manera de hacer Europa”.BMC201920192019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://doi.org/10.1186/s13063-018-3106-5http://hdl.handle.net/10459.1/65821http://hdl.handle.net/10459.1/65821reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a https://doi.org/10.1186/s13063-018-3106-5Trials, 2019, vol. 20, núm. 38, p. 1-11cc-by (c) Montse Ballbè et al., 2019info:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by/4.0/oai:recercat.cat:10459.1/658212026-05-29T05:05:01Z
dc.title.none.fl_str_mv Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial
title Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial
spellingShingle Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial
Ballbè, Montse
Mental disorders
Clinical trial
Smoking cessation
Telephone
title_short Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial
title_full Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial
title_fullStr Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial
title_full_unstemmed Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial
title_sort Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial
dc.creator.none.fl_str_mv Ballbè, Montse
Martínez Martínez, Cristina
Feliu, Ariadna
Torres, Núria
Nieva, Gemma
Pinet, Cristina
Raich, Antònia
Mondon, Sílvia
Barrio, Pablo
Hernández-Ribas, Rosa
Vicens, Jordi
Costa, Sílvia
Vilaplana Mayoral, Jordi
Alaustre, Laura
Vilalta, Eva
Blanch, Roser
Subirà, Susana
Bruguera, Eugeni
Suelves, Josep Maria
Guydish, Joseph
Fernández, Esteve
author Ballbè, Montse
author_facet Ballbè, Montse
Martínez Martínez, Cristina
Feliu, Ariadna
Torres, Núria
Nieva, Gemma
Pinet, Cristina
Raich, Antònia
Mondon, Sílvia
Barrio, Pablo
Hernández-Ribas, Rosa
Vicens, Jordi
Costa, Sílvia
Vilaplana Mayoral, Jordi
Alaustre, Laura
Vilalta, Eva
Blanch, Roser
Subirà, Susana
Bruguera, Eugeni
Suelves, Josep Maria
Guydish, Joseph
Fernández, Esteve
author_role author
author2 Martínez Martínez, Cristina
Feliu, Ariadna
Torres, Núria
Nieva, Gemma
Pinet, Cristina
Raich, Antònia
Mondon, Sílvia
Barrio, Pablo
Hernández-Ribas, Rosa
Vicens, Jordi
Costa, Sílvia
Vilaplana Mayoral, Jordi
Alaustre, Laura
Vilalta, Eva
Blanch, Roser
Subirà, Susana
Bruguera, Eugeni
Suelves, Josep Maria
Guydish, Joseph
Fernández, Esteve
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Mental disorders
Clinical trial
Smoking cessation
Telephone
topic Mental disorders
Clinical trial
Smoking cessation
Telephone
description Background 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. 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. Methods A 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. Discussion This 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
publishDate 2019
dc.date.none.fl_str_mv 2019
2019
2019
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://doi.org/10.1186/s13063-018-3106-5
http://hdl.handle.net/10459.1/65821
http://hdl.handle.net/10459.1/65821
url https://doi.org/10.1186/s13063-018-3106-5
http://hdl.handle.net/10459.1/65821
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a https://doi.org/10.1186/s13063-018-3106-5
Trials, 2019, vol. 20, núm. 38, p. 1-11
dc.rights.none.fl_str_mv cc-by (c) Montse Ballbè et al., 2019
info:eu-repo/semantics/openAccess
http://creativecommons.org/licenses/by/4.0/
rights_invalid_str_mv cc-by (c) Montse Ballbè et al., 2019
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BMC
publisher.none.fl_str_mv BMC
dc.source.none.fl_str_mv reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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