Tobacco Use DisorderESCIMNCT05045326
Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital
A study testing Smoking cessation program in people with Tobacco Use Disorder and Smoking Cessation, run by Hospital Clinic of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Smoking Cessation, Mental Disorder
- What is being tested?
- Smoking cessation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2021to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Antoni Gual, PhD, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Tobacco Use Disorder, Smoking Cessation, Mental Disorder
- Being tested
- Smoking cessation program, Placebo Comparator: Brief Counselling
- Keywords
- Motivational Interviewing, Group Counseling
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation programBehavioural
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 CounsellingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Smoking cessation program |
| Placebo Comparator: Brief Counselling | Placebo comparator | Participants in the placebo group will receive a brief intervention for smoking cessation. Receives: Behavioral: Placebo Comparator: Brief Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco use changes from baseline to post-intervention
Number of cigarettes smoked in past 24 hours.
Measured: An average of 2 months
Motivation to quit smoking changes from baseline to post-intervention
Individuals will be assessed with the Richmond test.
Measured: An average of 2 months
Cotinine levels in urine changes from baseline to post-intervention
Urine cotinine levels
Measured: An average of 2 months
Secondary outcomes (6)
Nicotine dependence changes from baseline to post-intervention
Change of self reported tobacco dependence using Fagerström Test for Nicotine Dependence.
Measured: An average of 2 months
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.
Measured: An average of 2 months
Smoking knowledge changes from baseline to post-intervention
Changes in smoking knowledge obtained through a knowledge questionnaire developed by the researchers.
Measured: An average of 2 months
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.
Measured: An average of 2 months
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.
Measured: An average of 2 months
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.
Measured: An average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start30 May 2021
- Primary completion27 Jul 2023 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoni Gual, PhD, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045326
- Sponsor's protocol ID
- HCB/2019/0580
- Acronym
- ESCIM
- Status last verified
- Feb 2023
- First submitted
- 29 Jul 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29059344Japuntich 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.
PubMed 31957794Martin-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.
PubMed 33083683Godoy 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.
PubMed 28645694Rice 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.
PubMed 29243221Lindson 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.
PubMed 31425622Jaen-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.
PubMed 30642365Jordan 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.
PubMed 31720963Guydish 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.
PubMed 32186480Knudsen 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.
PubMed 27314884Malone 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.
PubMed 29498459Martinez 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.
PubMed 30874373Martinez 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.
PubMed 32297373Andres 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.
PubMed 30205255Peckham 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.
PubMed 28705244
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital
- ClinicalTrials.gov ID
- NCT05045326
- Acronym / sponsor ID
- ESCIM / HCB/2019/0580
- Conditions
- Tobacco Use Disorder, Smoking Cessation, Mental Disorder
- Keywords
- Motivational Interviewing, Group Counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 27 Jul 2023 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Behavioral: Smoking cessation programParticipants 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. |
| Placebo Comparator: Brief Counselling | Placebo comparator | Behavioral: Placebo Comparator: Brief CounsellingParticipants in the placebo group will receive a brief intervention for smoking cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation programParticipants 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. | Behavioural | Experimental: Intervention Group |
| Placebo Comparator: Brief CounsellingParticipants 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. | Behavioural | Placebo Comparator: Brief Counselling |
Primary outcome
Tobacco use changes from baseline to post-intervention
Time frame: An average of 2 months
Number of cigarettes smoked in past 24 hours.
Motivation to quit smoking changes from baseline to post-intervention
Time frame: An average of 2 months
Individuals will be assessed with the Richmond test.
Cotinine levels in urine changes from baseline to post-intervention
Time frame: An average of 2 months
Urine cotinine levels
6 secondary outcomes
Nicotine dependence changes from baseline to post-intervention
Time frame: An average of 2 months
Self-efficacy to quit smoking changes from baseline to post-intervention
Time frame: An average of 2 months
Smoking knowledge changes from baseline to post-intervention
Time frame: An average of 2 months
Trait and state anxiety changes from baseline to post-intervention
Time frame: An average of 2 months
Depressive symptoms changes from baseline to post-intervention
Time frame: An average of 2 months
Self-reported clinically relevant psychological symptoms changes from baseline to post-intervention
Time frame: An average of 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 29059344Rogers 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.
- Background: PubMed 31957794Japuntich 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.
- Background: PubMed 33083683Martin-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.
- Background: PubMed 28645694Godoy 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.
- Background: PubMed 29243221Rice 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.
- Background: PubMed 31425622Lindson 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.
- Background: PubMed 30642365Jaen-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.
- Background: PubMed 31720963Jordan 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.
- Background: PubMed 32186480Guydish 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.
- Background: PubMed 27314884Knudsen 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.
- Background: PubMed 29498459Malone 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.
- Background: PubMed 30874373Martinez 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Gual, PhD, MD contact
Antoni Gual, PhD, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation program in people with Tobacco Use Disorder and Smoking Cessation, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoni Gual, PhD, MD (+34932275400 ext. 3167, TGUAL@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco use changes from baseline to post-intervention (time frame: An average of 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05045326, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.