Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients
NCT ID: NCT03230955
Last Updated: 2021-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2017-05-02
2020-12-31
Brief Summary
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To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.
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Detailed Description
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Objectives: To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.
Methods: Pragmatic randomized clinical trial, single-blind, with allocation 2:1 \[Intervention Group (IG) and control group (CG)\] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively for 12 months, and the CG only brief counselling after discharge. The sample size, calculated with an expected difference of 15 points on withdrawal between groups, α=0.05 and β=0.10 and 20% loss, will be of 334 (IG) and 176 (CG), which will be doubled to allow stratified analyses. Variables: a) dependent variables: self-reported smoking abstinence and verified by expired carbon monoxide levels, quit attempts, time of abstinence, motivation and self-efficacy to quit, and b) independent variables: age, sex and main disorder. Data analysis: multivariate logistic regression (odds ratio and confidence interval, CI 95%) of abstinence and other variables adjusted for potential confounding variables. Number of smokers needed to treat (NNT, and its 95% CI) to achieve one abstinent will be calculated.
Hypothesis: Abstinence rate (≥ 15%) of enrolled patients between groups. If the intervention is effective, the pragmatic nature of the study will permit to transfer it to the routine clinical practice with a reasonable investment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Psychological and psycho-educational support
The intervention group (IG) \[that will receive telephone-based assistance to quit (including psychological and psycho-educational support and pharmacological treatment advice, if required) provided by trained nurses who will proactively call at one week, 15 day, a month, 3, 6 and 12 months after discharge, plus the calls made by the patients during the process\]
Psychological and psycho-educational support by phone
The intervention is based on cognitive-behavioural therapy (CBT). The intervention, in order to achieve behavioural changes, will include components based in Bandura's social learning theory and social cognitive theory (Bandura, 1986) and the transtheorical model of change (Prochaska, 1992). It has been shown that expectations and self-efficacy are behavioural predictors and that they are an effective framework for the assistance to quit smoking. This theory allows evaluating patient motivation phase and adapting the interventions according to each phase (Fiore, 2011)
Control Group
The control group (CG) \[that will receive only a brief counselling session after discharge\]
Brief counselling session
Brief counselling session
Interventions
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Psychological and psycho-educational support by phone
The intervention is based on cognitive-behavioural therapy (CBT). The intervention, in order to achieve behavioural changes, will include components based in Bandura's social learning theory and social cognitive theory (Bandura, 1986) and the transtheorical model of change (Prochaska, 1992). It has been shown that expectations and self-efficacy are behavioural predictors and that they are an effective framework for the assistance to quit smoking. This theory allows evaluating patient motivation phase and adapting the interventions according to each phase (Fiore, 2011)
Brief counselling session
Brief counselling session
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. adults of both sexes ≥ 18 years to ≤76 years of age;
3. that have stayed in an Acute or Detoxification mental health unit for more than 24 hours;
4. with a telephone, fixed or mobile;
5. residents in the metropolitan area of Barcelona;
6. that provide their informed consent.
Exclusion Criteria
2. with dementia or brain damage;
3. that do not speak Spanish or Catalan;
4. pregnant women;
5. with hearing and/or speech deficit;
6. with insufficient reading comprehension skills in Spanish or Catalan;
7. that are trying to quit in smoking in another centre, or using another intervention in that moment;
8. that have voluntarily requested discharge;
9. that plan to shift their domicile outside of Barcelona county.
18 Years
76 Years
ALL
Yes
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Hospital Clinic of Barcelona
OTHER
Hospital Vall d'Hebron
OTHER
Hestia Alliance
OTHER
Institut Català d'Oncologia
OTHER
Responsible Party
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Principal Investigators
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Cristina Martínez, RN,BA, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Català d'Oncologia
Locations
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Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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References
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Ballbe M, Martinez C, Salto E, Cabezas C, Riccobene A, Valverde A, Gual A, Fernandez E. Maintenance of tobacco cessation programmes in public hospitals in Catalonia, Spain. Addict Behav. 2015 Mar;42:136-9. doi: 10.1016/j.addbeh.2014.11.028. Epub 2014 Nov 26.
Ballbe M, Nieva G, Mondon S, Pinet C, Bruguera E, Salto E, Fernandez E, Gual A; Smoking and Mental Health Group. Smoke-free policies in psychiatric services: identification of unmet needs. Tob Control. 2012 Nov;21(6):549-54. doi: 10.1136/tobaccocontrol-2011-050029. Epub 2011 Sep 20.
Ballbe M, Sureda X, Martinez-Sanchez JM, Salto E, Gual A, Fernandez E. Second-hand smoke in mental healthcare settings: time to implement total smoke-free bans? Int J Epidemiol. 2013 Jun;42(3):886-93. doi: 10.1093/ije/dyt014. Epub 2013 Mar 29.
Ballbe M, Sureda X, Martinez-Sanchez JM, Fu M, Salto E, Gual A, Fernandez E. Secondhand smoke in psychiatric units: patient and staff misperceptions. Tob Control. 2015 Oct;24(e3):e212-20. doi: 10.1136/tobaccocontrol-2014-051585. Epub 2014 Sep 19.
Banham L, Gilbody S. Smoking cessation in severe mental illness: what works? Addiction. 2010 Jul;105(7):1176-89. doi: 10.1111/j.1360-0443.2010.02946.x. Epub 2010 May 11.
Chabrol H, Niezborala M, Chastan E, de Leon J. Comparison of the Heavy Smoking Index and of the Fagerstrom Test for Nicotine Dependence in a sample of 749 cigarette smokers. Addict Behav. 2005 Aug;30(7):1474-7. doi: 10.1016/j.addbeh.2005.02.001.
Fiore MC, Baker TB. Clinical practice. Treating smokers in the health care setting. N Engl J Med. 2011 Sep 29;365(13):1222-31. doi: 10.1056/NEJMcp1101512.
Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25.
Martinez C, Fu M, Martinez-Sanchez JM, Ballbe M, Puig M, Garcia M, Carabasa E, Salto E, Fernandez E. Tobacco control policies in hospitals before and after the implementation of a national smoking ban in Catalonia, Spain. BMC Public Health. 2009 May 28;9:160. doi: 10.1186/1471-2458-9-160.
Martinez C, Guydish J, Le T, Tajima B, Passalacqua E. Predictors of quit attempts among smokers enrolled in substance abuse treatment. Addict Behav. 2015 Jan;40:1-6. doi: 10.1016/j.addbeh.2014.08.005. Epub 2014 Aug 27.
Morris CD, Tedeschi GJ, Waxmonsky JA, May M, Giese AA. Tobacco quitlines and persons with mental illnesses: perspective, practice, and direction. J Am Psychiatr Nurses Assoc. 2009 Feb;15(1):32-40. doi: 10.1177/1078390308330050.
Morris CD, Waxmonsky JA, May MG, Tinkelman DG, Dickinson M, Giese AA. Smoking reduction for persons with mental illnesses: 6-month results from community-based interventions. Community Ment Health J. 2011 Dec;47(6):694-702. doi: 10.1007/s10597-011-9411-z. Epub 2011 May 10.
Prochaska JJ, Hall SE, Delucchi K, Hall SM. Efficacy of initiating tobacco dependence treatment in inpatient psychiatry: a randomized controlled trial. Am J Public Health. 2014 Aug;104(8):1557-65. doi: 10.2105/AJPH.2013.301403. Epub 2013 Aug 15.
Twyman L, Bonevski B, Paul C, Bryant J. Perceived barriers to smoking cessation in selected vulnerable groups: a systematic review of the qualitative and quantitative literature. BMJ Open. 2014 Dec 22;4(12):e006414. doi: 10.1136/bmjopen-2014-006414.
Ballbe M, Martinez C, Feliu A, Torres N, Nieva G, Pinet C, Raich A, Mondon S, Barrio P, Hernandez-Ribas R, Vicens J, Costa S, Vilaplana J, Alaustre L, Vilalta E, Blanch R, Subira S, Bruguera E, Suelves JM, Guydish J, Fernandez E. Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial. Trials. 2019 Jan 11;20(1):38. doi: 10.1186/s13063-018-3106-5.
Other Identifiers
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061 QUIT_MENTAL PI15/00875
Identifier Type: -
Identifier Source: org_study_id
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