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Completed

NCT Number: NCT03230955

Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients

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.

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Key information

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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)

Other names: Telephone-based motivational intervention

Brief counselling session

Other

Brief counselling session

Other names: Brief advice

Primary outcomes

  1. Change from tobacco consumption abstinence at 12 months

    Time frame: through study completion, an average of 1 year

    Tobacco consumption abstinence (yes/no), self-reported the day of recruitment and 12 months after discharge (7 days abstinence prior to the evaluation point)

Secondary outcomes

  1. Change in the level of self-efficacy to quit smoking

    Time frame: through study completion, an average of 1 year

    Change of self reported self-efficacy (using a Likert scale from 0 to 10)

  2. Change of motivation to quit smoking (stage of change)

    Time frame: through study completion, an average of 1 year

    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).

  3. Attempts to quit smoking

    Time frame: through study completion, an average of 1 year

    Number of serious quit attempts after discharge

Sponsors and collaborators

Lead sponsor

Institut Català d'Oncologia

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: QUITMENTAL

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2017
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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