Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital

Smoking Cessation Clinical Trial

— ESCIM  

Official title:

Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045326
• Other study ID #: HCB/2019/0580
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2021
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2023
• Source: Hospital Clinic of Barcelona
• Contact: Antoni Gual, PhD, MD
• Phone: +34932275400
• Email: TGUAL[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 30, 2024
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Mental Disorder
• Mental Disorders
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Behavioral:
• Smoking cessation program
Participants will receive intensive treatment for smoking cessation during day hospital admission. The intervention is carried out individually and in an open-ended group. The treatment, provided by trained and multidisciplinary professionals (nursing, psychiatry, psychologist, occupational therapist, social work), includes psychological, psycho-educational support, and pharmacological treatment advice. The group intervention takes place once a week and is divided into six structured sessions that are repeated. Sessions include nicotine addiction and withdrawal, health consequences, benefits of quitting, motivation for change, triggers, coping responses, social support, decision making, pharmacological treatment advice and healthy lifestyle habits.
• Placebo Comparator: Brief Counselling
Participants will receive brief counseling on smoking cessation during their hospital stay. This brief intervention is based on motivational techniques to increase motivation to reduce tobacco use or to initiate treatment.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (20)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Muller DP, de Haan L. [Smoking cessation and schizophrenia]. Tijdschr Psychiatr. 2017;59(5):297-301. Dutch. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use changes from baseline to post-intervention	Number of cigarettes smoked in past 24 hours.	An average of 2 months
Primary	Motivation to quit smoking changes from baseline to post-intervention	Individuals will be assessed with the Richmond test.	An average of 2 months
Primary	Cotinine levels in urine changes from baseline to post-intervention	Urine cotinine levels	An average of 2 months
Secondary	Nicotine dependence changes from baseline to post-intervention	Change of self reported tobacco dependence using Fagerström Test for Nicotine Dependence.	An average of 2 months
Secondary	Self-efficacy to quit smoking changes from baseline to post-intervention	Change of self reported self-efficacy (using a Likert scale from 0 to 10). Minimum value: 0. Maximum value: 10. Higher scores indicate more self-efficacy to quit smoking.	An average of 2 months
Secondary	Smoking knowledge changes from baseline to post-intervention	Changes in smoking knowledge obtained through a knowledge questionnaire developed by the researchers.	An average of 2 months
Secondary	Trait and state anxiety changes from baseline to post-intervention	Changes in anxiety obtained through the State-Trait Anxiety Inventory. Minimum value: 20. Maximum value: 80. Higher scores indicate greater anxiety.	An average of 2 months
Secondary	Depressive symptoms changes from baseline to post-intervention	Changes in depressive symptoms obtained through the Montgomery and Asberg Depression. Minimum value: 0 Maximum value: 60. A score of less than 10 points indicate the absence of depressive disorder.	An average of 2 months
Secondary	Self-reported clinically relevant psychological symptoms changes from baseline to post-intervention	Changes in self-reported clinically relevant psychological symptoms through the Brief Symptom Inventory. Minimum value: 0. Maximum value: 72. Higher scores indicate higher levels of psychological distress.	An average of 2 months

External Links

•   Clinical Intervention guide on tobacco use in patients with mental disorders. Government of Catalonia. 2012.
•   The World Health Organization report on the global tobacco epidemic 2019: offer help to quit tobacco use" tracks the status of the tobacco epidemic and interventions to combat it.