Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients

NCT03230955 | Completed

• 1 other identifier: 061 QUIT_MENTAL PI15/00875
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Disorder; Smoking Cessation; Motivation

Keywords

Randomized clinical trial; Hotlines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in the level of self-efficacy to quit smoking

  through study completion, an average of 1 year

• Change of motivation to quit smoking (stage of change)

  through study completion, an average of 1 year

• Attempts to quit smoking

  through study completion, an average of 1 year

Study Arms (2)

Psychological and psycho-educational support

EXPERIMENTAL

The intervention group (IG) \[that will receive telephone-based assistance to quit (including psychological and psycho-educational support and pharmacological treatment advice, if required) provided by trained nurses who will proactively call at one week, 15 day, a month, 3, 6 and 12 months after discharge, plus the calls made by the patients during the process\]

Behavioral: Psychological and psycho-educational support by phone

Control Group

ACTIVE COMPARATOR

The control group (CG) \[that will receive only a brief counselling session after discharge\]

Other: Brief counselling session

Interventions

Psychological and psycho-educational support by phone BEHAVIORAL

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)

Also known as: Telephone-based motivational intervention

Psychological and psycho-educational support

Brief counselling session OTHER

Brief counselling session

Also known as: Brief advice

Control Group

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smokers;
• adults of both sexes ≥ 18 years to ≤76 years of age;
• that have stayed in an Acute or Detoxification mental health unit for more than 24 hours;
• with a telephone, fixed or mobile;
• residents in the metropolitan area of Barcelona;
• that provide their informed consent.

You may not qualify if:

• patient discharged from the psychiatric emergency room;
• with dementia or brain damage;
• that do not speak Spanish or Catalan;
• pregnant women;
• with hearing and/or speech deficit;
• with insufficient reading comprehension skills in Spanish or Catalan;
• that are trying to quit in smoking in another centre, or using another intervention in that moment;
• that have voluntarily requested discharge;
• that plan to shift their domicile outside of Barcelona county.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead
• Hospital Universitari de Bellvitge: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Vall d'Hebron: collaborator
• Hestia Alliance: collaborator

Study Sites (1)

Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Related Publications (16)

• 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.

  PMID: 25462661 BACKGROUND

• 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.

  PMID: 21933940 BACKGROUND

• 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.

  PMID: 23543600 BACKGROUND

• 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.

  PMID: 25239470 BACKGROUND

• 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.

  PMID: 20491721 BACKGROUND

• 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.

  PMID: 16022945 BACKGROUND

• 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.

  PMID: 21991895 BACKGROUND

• 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.

  PMID: 1932883 BACKGROUND

• 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.

  PMID: 12745503 BACKGROUND

• 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.

  PMID: 19473549 BACKGROUND

• 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.

  PMID: 25218064 BACKGROUND

• 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.

  PMID: 21665792 BACKGROUND

• 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.

  PMID: 21556784 BACKGROUND

• 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.

  PMID: 23948001 BACKGROUND

• 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.

  PMID: 25534212 BACKGROUND

• 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.

  PMID: 30635072 DERIVED

MeSH Terms

Conditions

Mental Disorders; Smoking Cessation

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Cristina Martínez, RN,BA, PhD

  Institut Català d'Oncologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants and hospital clinicians will be blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into IG and CG with 2:1 allocation using mapping software, because it is expected a larger number of losses to follow-up in the CG. GI patients will be contacted by a nurse of the 061CatSalut Respon "quit line" who will have received specific training in intervening smokers with mental disorders. The call will take place within the first 48 h after discharge from the hospitals. The patients of the CG will be contacted by a team of the 061 CatSalut Respon in order to provide a brief counselling (first call) and evaluate their use of tobacco during the 1st, 6th and 12th month.

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: July 27, 2017
• Study Start: May 2, 2017
• Primary Completion: May 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)