Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients (QUITMENTAL)

October 8, 2021 updated by: Institut Català d'Oncologia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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]
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 Names:
  • Telephone-based motivational intervention
Active Comparator: Control Group
The control group (CG) [that will receive only a brief counselling session after discharge]
Other: Brief counselling session
Brief counselling session
Other Names:
  • Brief advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 1 year
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).
through study completion, an average of 1 year
Attempts to quit smoking
Time Frame: through study completion, an average of 1 year
Number of serious quit attempts after discharge
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Català d'Oncologia

Collaborators

Hospital Clinic of Barcelona
Hospital Universitari de Bellvitge
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Vall d'Hebron
Hestia Alliance

Investigators

  • Principal Investigator: Cristina Martínez, RN,BA, PhD, Institut Catala D'oncologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 27, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 061 QUIT_MENTAL PI15/00875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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