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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03230955
Recruitment Status : Unknown
Verified October 2018 by Institut Català d'Oncologia.
Recruitment status was:  Recruiting
First Posted : July 27, 2017
Last Update Posted : October 3, 2018
Sponsor:
Collaborators:
Hospital Universitari de Bellvitge
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Clinic of Barcelona
Hospital Vall d'Hebron
Hestia Alliance
Information provided by (Responsible Party):
Institut Català d'Oncologia

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.


Condition or disease Intervention/treatment Phase
Mental Disorder Smoking Cessation Motivation Behavioral: Psychological and psycho-educational support by phone Other: Brief counselling session Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1002 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: Participants and hospital clinicians will be blind
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients: Pragmatic Clinical Trial
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Brief advice




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230955


Contacts
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Contact: Cristina Martinez, RN,BA, PhD 932607335 cmartinez@iconcologia.net
Contact: Esteve Fernandez, MD, MPH, PhD 932607357 efernandez@iconcologia.net

Locations
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Spain
Hospital Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Contact: Cristina Martínez         
Sponsors and Collaborators
Institut Català d'Oncologia
Hospital Universitari de Bellvitge
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Clinic of Barcelona
Hospital Vall d'Hebron
Hestia Alliance
Investigators
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Principal Investigator: Cristina Martínez, RN,BA, PhD Catalan Institute of Oncology
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT03230955    
Other Study ID Numbers: 061 QUIT_MENTAL PI15/00875
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Català d'Oncologia:
Randomized clinical trial
Hotlines
Additional relevant MeSH terms:
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Mental Disorders