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

NCT05045326 | Unknown

• 1 other identifier: HCB/2019/0580
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Smoking Cessation; Mental Disorder

Keywords

Motivational Interviewing; Group Counseling

Outcome Measures

Primary Outcomes (3)

• Tobacco use changes from baseline to post-intervention

  Number of cigarettes smoked in past 24 hours.

  An average of 2 months

• Motivation to quit smoking changes from baseline to post-intervention

  Individuals will be assessed with the Richmond test.

  An average of 2 months

• Cotinine levels in urine changes from baseline to post-intervention

  Urine cotinine levels

  An average of 2 months

Secondary Outcomes (6)

• Nicotine dependence changes from baseline to post-intervention

  An average of 2 months

• Self-efficacy to quit smoking changes from baseline to post-intervention

  An average of 2 months

• Smoking knowledge changes from baseline to post-intervention

  An average of 2 months

• Trait and state anxiety changes from baseline to post-intervention

  An average of 2 months

• Depressive symptoms changes from baseline to post-intervention

  An average of 2 months

Study Arms (2)

Experimental: Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive an intensive motivational intervention with individual and group treatment for smoking cessation. The treatment, provided by trained professionals, will include psychological, psycho-educational support and pharmacological treatment advice.

Behavioral: Smoking cessation program

Placebo Comparator: Brief Counselling

PLACEBO COMPARATOR

Participants in the placebo group will receive a brief intervention for smoking cessation.

Behavioral: Placebo Comparator: Brief Counselling

Interventions

Smoking cessation program BEHAVIORAL

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.

Experimental: Intervention Group

Placebo Comparator: Brief Counselling BEHAVIORAL

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.

Placebo Comparator: Brief Counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Related Publications (20)

• 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.

  PMID: 29059344 BACKGROUND

• 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.

  PMID: 31957794 BACKGROUND

• 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.

  PMID: 33083683 BACKGROUND

• 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.

  PMID: 28645694 BACKGROUND

• 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.

  PMID: 29243221 BACKGROUND

• 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.

  PMID: 31425622 BACKGROUND

• 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.

  PMID: 30642365 BACKGROUND

• 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.

  PMID: 31720963 BACKGROUND

• 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.

  PMID: 32186480 BACKGROUND

• 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.

  PMID: 27314884 BACKGROUND

• 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.

  PMID: 29498459 BACKGROUND

• 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.

  PMID: 30874373 BACKGROUND

• 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.

  PMID: 32297373 BACKGROUND

• 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.

  PMID: 30205255 BACKGROUND

• 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.

  PMID: 28705244 BACKGROUND

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

  PMID: 28593623 BACKGROUND

• 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.

  PMID: 29708388 BACKGROUND

• 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.

  PMID: 33768256 BACKGROUND

• 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.

  PMID: 29733376 BACKGROUND

• 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.

  PMID: 27325123 BACKGROUND

Related Links

• 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.
• Clinical Intervention guide on tobacco use in patients with mental disorders. Government of Catalonia. 2012.

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Mental Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Health Behavior; Behavior

Study Officials

• Antoni Gual, PhD, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoni Gual, PhD, MD

CONTACT

+34932275400; TGUAL@clinic.cat

Antoni Gual, PhD, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 16, 2021
• Study Start: May 30, 2021
• Primary Completion: July 27, 2023
• Study Completion: July 30, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)