Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients

Smoking Cessation Clinical Trial

— QUITMENTAL  

Official title:

Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients: Pragmatic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230955
• Other study ID #: 061 QUIT_MENTAL PI15/00875
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: Institut Català d'Oncologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Description:

Background: People suffering from mental illness are more likely to smoke. In Spain, up to 75% of patients hospitalized for mental disorders smoke, tripling the general population consumption. Life expectancy for people with severe mental illnesses is decreased by up to 25 years in comparison to the general population, mainly due to diseases caused or worsened by smoking. Hospitalized patients without monitoring after discharge quickly restore their tobacco use to previous levels. This evidence suggests the need of an appropriate follow-up intervention to prevent relapse after discharge and achieve higher rates of withdrawal in this population.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

Inclusion Criteria:

1. smokers;

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:

1. patient discharged from the psychiatric emergency room;

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.

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Motivation
• Smoking Cessation

Intervention

Behavioral:
• 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)

Other:
• Brief counselling session
Brief counselling session

Locations

Country	Name	City	State
Spain	Hospital Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Institut Català d'Oncologia	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hestia Alliance, Hospital Clinic of Barcelona, Hospital Universitari de Bellvitge, Hospital Vall d'Hebron

Country where clinical trial is conducted

Spain, 

References & Publications (15)

Ballbè M, Martínez C, Saltó E, Cabezas C, Riccobene A, Valverde A, Gual A, Fernández 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. — View Citation

Ballbè M, Nieva G, Mondon S, Pinet C, Bruguera E, Saltó E, Fernández 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. — View Citation

Ballbè M, Sureda X, Martínez-Sánchez JM, Fu M, Saltó E, Gual A, Fernández 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. — View Citation

Ballbè M, Sureda X, Martínez-Sánchez JM, Saltó E, Gual A, Fernández 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. — View Citation

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. Erratum in: Nicotine Tob Res. 2003 Aug;5(4):603. — View Citation

Martínez C, Fu M, Martínez-Sánchez JM, Ballbè M, Puig M, García M, Carabasa E, Saltó E, Fernández 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. — View Citation

Martínez 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from tobacco consumption abstinence at 12 months	Tobacco consumption abstinence (yes/no), self-reported the day of recruitment and 12 months after discharge (7 days abstinence prior to the evaluation point)	through study completion, an average of 1 year
Secondary	Change in the level of self-efficacy to quit smoking	Change of self reported self-efficacy (using a Likert scale from 0 to 10)	through study completion, an average of 1 year
Secondary	Change of motivation to quit smoking (stage of change)	The Stages of Change Model helps to know the patient's motivation to quit, or stage of change, in order to allow clinicians to tailor interventions according to each stage (Prochaska, 1992).	through study completion, an average of 1 year
Secondary	Attempts to quit smoking	Number of serious quit attempts after discharge	through study completion, an average of 1 year