Clinical trial NCT05045326: Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital
Official title: Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Use Disorder
Smoking Cessation
Mental Disorder
Keywords: Motivational Interviewing
Group Counseling
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Background: Nicotine contained in tobacco is highly addictive and tobacco use is a major risk factor for cardiovascular and respiratory diseases. Every year, more than 8 million people die from tobacco use.

Smoking-related mortality is significantly higher in people with serious mental illness. Is estimated that half of all deaths among individuals with mental illnesses are attributable to tobacco use. People with serious mental illness have greater daily tobacco consumption, nicotine dependence, and smoking relapse. While significant progress has been made in reducing tobacco use within the general population, rates of tobacco use remain high among individuals with mental illness. Smoking cessation often requires numerous attempts by these people. Thus, smokers with mental health illnesses may find it more difficult to quit, although highly motivated to quit.

Smoking cessation during hospitalization (total or partial) is cost-effective, as it reduces hospital readmissions, and mortality, and improves smokers' quality of life. Available quitting aids are both safe and effective in supporting cessation in tobacco users with mental illness and stopping smoking is associated with an improvement in mental health.

The investigators aimed to evaluate the feasibility and efficacy of adding an intensive smoking intervention to the usual treatment for patients with psychiatric disorders attending a day hospital of a tertiary hospital.

Detailed description: The investigators will perform a quasi-experimental, longitudinal, and prospective study in the mental health day hospital of the Hospital Clinic of Barcelona.

Adults attending the day hospital and willing to participate, under informed consent, will be invited to participate. Consecutive eligible individuals will be recruited and will be assigned to two groups, the control group, and the experimental group. Initially, patients will be recruited for the control group, once the control group is completed the experimental group will begin.

An assessment will be conducted at baseline (admission) and in the discharge. Sociodemographic and clinical data will be obtained.

Eligibility criteria: Inclusion Criteria:

* Mental health day hospital inpatient.
* Smoker of at least 1 cigarette per day, electronic cigarette, or heated tobacco product daily for at least 1 month.
* Individuals who accept to participate in the study and give informed consent.

Exclusion Criteria:

* Cognitive impairment, dementia, or brain damage.
* Medically unstable.
* Explicitly demanding tobacco treatment.
* Trying to quit smoking using another intervention.
* Insufficient comprehension skills in Spanish or Catalan.

Primary outcomes:
measure: Tobacco use changes from baseline to post-intervention
timeFrame: An average of 2 months
measure: Motivation to quit smoking changes from baseline to post-intervention
timeFrame: An average of 2 months
measure: Cotinine levels in urine changes from baseline to post-intervention
timeFrame: An average of 2 months
Secondary outcomes:
measure: Nicotine dependence changes from baseline to post-intervention
timeFrame: An average of 2 months
measure: Self-efficacy to quit smoking changes from baseline to post-intervention
timeFrame: An average of 2 months
measure: Smoking knowledge changes from baseline to post-intervention
timeFrame: An average of 2 months
measure: Trait and state anxiety changes from baseline to post-intervention
timeFrame: An average of 2 months
measure: Depressive symptoms changes from baseline to post-intervention
timeFrame: An average of 2 months
measure: Self-reported clinically relevant psychological symptoms changes from baseline to post-intervention
timeFrame: An average of 2 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Antoni Gual, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers ES, Gillespie C, Smelson D, Sherman SE. A Qualitative Evaluation of Mental Health Clinic Staff Perceptions of Barriers and Facilitators to Treating Tobacco Use. Nicotine Tob Res. 2018 Sep 4;20(10):1223-1230. doi: 10.1093/ntr/ntx204.
citation: Japuntich SJ, Hammett PJ, Rogers ES, Fu S, Burgess DJ, El Shahawy O, Melzer AC, Noorbaloochi S, Krebs P, Sherman SE. Effectiveness of Proactive Tobacco Cessation Treatment Outreach Among Smokers With Serious Mental Illness. Nicotine Tob Res. 2020 Aug 24;22(9):1433-1438. doi: 10.1093/ntr/ntaa013.
citation: Martin-Cantera C, Sanmartin JMI, Martinez AF, Lorenzo CM, Cohen VB, Jimenez MLC, Perez-Teijon SC, Osca JARI, Garcia RC, Fernandez JL, Domenech MAG, Navascues MAM, Chaves ES, Ibanez MLR, Rubio VG, Rayo SM, Otero BM, Lopez LG, Guillem FC, Fuente FM, Ruiz DB, Rodriguez AIH, Caballero JDG, Moreno CB, Pubil MP, Grau ML. Good practice regarding smoking cessation management in Spain: Challenges and opportunities for primary care physicians and nurses. Tob Prev Cessat. 2020 Sep 21;6:55. doi: 10.18332/tpc/126630. eCollection 2020.
citation: Godoy R, Callejas FJ, Cruz J, Tornero AI, Tarraga PJ, Rodriguez-Montes JA. [Comparative analysis: Effectiveness of nicotine addiction treatment in people with psychiatric comorbidity]. Semergen. 2018 May-Jun;44(4):249-256. doi: 10.1016/j.semerg.2017.03.008. Epub 2017 Jun 20. Spanish.
citation: Rice VH, Heath L, Livingstone-Banks J, Hartmann-Boyce J. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2017 Dec 15;12(12):CD001188. doi: 10.1002/14651858.CD001188.pub5.
citation: Lindson N, Thompson TP, Ferrey A, Lambert JD, Aveyard P. Motivational interviewing for smoking cessation. Cochrane Database Syst Rev. 2019 Jul 31;7(7):CD006936. doi: 10.1002/14651858.CD006936.pub4.
citation: Jaen-Moreno MJ, Feu N, Redondo-Ecija J, Montiel FJ, Gomez C, Del Pozo GI, Alcala JA, Gutierrez-Rojas L, Balanza-Martinez V, Chauca GM, Carrion L, Osuna MI, Sanchez MD, Caro I, Ayora M, Valdivia F, Lopez MS, Poyato JM, Sarramea F. Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk - TIMER-): study protocol for a randomized controlled trial. Trials. 2019 Jan 14;20(1):47. doi: 10.1186/s13063-018-3139-9.
citation: Jordan K. A Provider - Patient Relationship: The Critical First Step of Smoking Cessation. J Gen Intern Med. 2020 Jan;35(1):10-11. doi: 10.1007/s11606-019-05276-0. No abstract available.
citation: Guydish J, Wahleithner J, Williams D, Yip D. Tobacco-free grounds implementation in California residential substance use disorder (SUD) treatment programs. J Addict Dis. 2020 Jan-Mar;38(1):55-63. doi: 10.1080/10550887.2020.1713687. Epub 2020 Jan 25.
citation: Knudsen HK. Implementation of smoking cessation treatment in substance use disorder treatment settings: a review. Am J Drug Alcohol Abuse. 2017 Mar;43(2):215-225. doi: 10.1080/00952990.2016.1183019. Epub 2016 Jun 17.
citation: Malone V, Harrison R, Daker-White G. Mental health service user and staff perspectives on tobacco addiction and smoking cessation: A meta-synthesis of published qualitative studies. J Psychiatr Ment Health Nurs. 2018 May;25(4):270-282. doi: 10.1111/jpm.12458. Epub 2018 Apr 14.
citation: Martinez C, Castellano Y, Andres A, Fu M, Feliu A, Anton L, Ballbe M, Fernandez P, Cabrera S, Riccobene A, Gavilan E, Baena A, Margalef M, Tigova O, Quiros N, Guillen O, Company A, Fernandez E. Impact of an Online Training Program in Smoking Cessation Interventions in Hospitals. J Nurs Scholarsh. 2019 Jul;51(4):449-458. doi: 10.1111/jnu.12469. Epub 2019 Mar 15.
citation: Martinez C, Feliu A, Castellano Y, Fu M, Fernandez P, Cabrera-Jaime S, Puig-Llobet M, Galimany J, Guydish J, Fernandez E; ETHIF Research Group. Factors associated with receipt of the 5As model of brief intervention for smoking cessation among hospitalized patients. Addiction. 2020 Nov;115(11):2098-2112. doi: 10.1111/add.15076. Epub 2020 Apr 28.
citation: Andres A, Castellano Y, Fu M, Feliu A, Ballbe M, Anton L, Baena A, Fernandez E, Martinez C. Exploring individual and contextual factors contributing to tobacco cessation intervention implementation. Addict Behav. 2019 Jan;88:163-168. doi: 10.1016/j.addbeh.2018.08.003. Epub 2018 Aug 6.
citation: Peckham E, Brabyn S, Cook L, Tew G, Gilbody S. Smoking cessation in severe mental ill health: what works? an updated systematic review and meta-analysis. BMC Psychiatry. 2017 Jul 14;17(1):252. doi: 10.1186/s12888-017-1419-7.
citation: Muller DP, de Haan L. [Smoking cessation and schizophrenia]. Tijdschr Psychiatr. 2017;59(5):297-301. Dutch.
citation: Zvolensky MJ, Rosenfield D, Garey L, Kauffman BY, Langdon KJ, Powers MB, Otto MW, Davis ML, Marcus BH, Church TS, Frierson GM, Hopkins LB, Paulus DJ, Baird SO, Smits JAJ. Does exercise aid smoking cessation through reductions in anxiety sensitivity and dysphoria? Health Psychol. 2018 Jul;37(7):647-657. doi: 10.1037/hea0000588. Epub 2018 Apr 30.
citation: Nieva G, Ballbe M, Cano M, Carcole B, Fernandez T, Martinez A, Mondon S, Raich A, Roig P, Serra I, Serrano J, Pinet C. Smoking cessation interventions in substance use disorders treatment centers of Catalonia: The abandoned addiction. Adicciones. 2022 Jul 1;34(3):227-234. doi: 10.20882/adicciones.1492. English, Spanish.
citation: Healey A, Roberts S, Sevdalis N, Goulding L, Wilson S, Shaw K, Jolley C, Robson D. A Cost-Effectiveness Analysis of Stop Smoking Interventions in Substance-Use Disorder Populations. Nicotine Tob Res. 2019 Apr 17;21(5):623-630. doi: 10.1093/ntr/nty087.
citation: Ballbe M, Gual A, Nieva G, Salto E, Fernandez E; Tobacco and Mental Health Working Group. Deconstructing myths, building alliances: a networking model to enhance tobacco control in hospital mental health settings. Gac Sanit. 2016 Sep-Oct;30(5):389-92. doi: 10.1016/j.gaceta.2016.04.017. Epub 2016 Jun 17.