Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients (QUITMENTAL)
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|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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||1002 participants|
|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 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|
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
- 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)
- 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)
- 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).
- Attempts to quit smoking [ Time Frame: through study completion, an average of 1 year ]Number of serious quit attempts after discharge
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
|Contact: Cristina Martinez, RN,BA, PhDemail@example.com|
|Contact: Esteve Fernandez, MD, MPH, PhDfirstname.lastname@example.org|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08908|
|Contact: Cristina Martínez|
|Principal Investigator:||Cristina Martínez, RN,BA, PhD||Catalan Institute of Oncology|