Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-28 @ 4:48 AM
Study NCT ID:
NCT02327104
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2014-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Mindfulness Based Relapse Prevention for Tobacco Dependents
Sponsor:
Federal University of São Paulo
Organization:
Study Overview
Official Title:
Evaluation of the Effectiveness of the Program of Mindfulness - Based Relapse Prevention (MBRP) as an Assistant Strategy to the Treatment of Tobacco Dependence
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MBRP
Brief Summary:
The dependence on tobacco is a predictable leading cause of death. The treatment based on the cognitive-behavioral therapy, including relapse prevention, became standard for tobacco dependents; yet scientific advances are still needed. Accordingly, the Mindfulness-Based Relapse Prevention (MBRP) program, adjunct to treatment, has shown promising results. The purpose of this project is to evaluate the effectiveness of the program MBRP as an adjunct in the treatment of smoking cessation instituted by the Ministry of Health, through the Instituto Nacional do Câncer (INCA) in Brazil.There will be a randomized clinical trial, with a simple random allocation. 60 patients will participate in this study receiving treatment (INCA'S standard) randomized between two groups: the MBRP Group (EG), which will undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the traditional model of Relapse Prevention.This study will be conducted at Ambulatory benchmark to smoking cessation treatment in the city of Juiz de Fora (Minas Gerais State- Brazil). Changes will be evaluated on several variables such as cessation of smoking, anxiety, depression, craving, positive and negative affects and will investigate the association of levels of mindfulness with smoking cessation. The data will be assessed at baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the study, besides being subjected to evaluations of regularly planned maintenance in the protocol of Ministry of Health. For data analysis there will be used Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect of two types of intervention on the evolution of comorbidities and abstinence of patients.
Detailed Description:
Treatments based on cognitive-behavioral therapy, including relapse prevention, have become standard for smoking cessation in Brazil and many other areas of the world; yet scientific advances are still needed.
Mindfulness-based approaches have more recently begun to be assessed and implemented for treatment of addiction. The Mindfulness-Based Relapse Prevention (MBRP) program, which integrates mindfulness practice with cognitive therapy approaches, has shown promising preliminary results in previous studies.
The purpose of the current study is to evaluate the effectiveness of the Mindfulness-Based Relapse Prevention program as an adjunct in the standard smoking cessation treatment instituted by the Ministry of Health in Brazil.
The study is a randomized clinical trial, with 60 patients diagnosed with nicotine dependence. 60 patients will participate in this study receiving treatment (instituted by the Ministry of Health in Brazil, through the Instituto Nacional do Câncer - INCA'S standard) randomized between two groups: the Experimental Group (EG), which will undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the traditional model of Relapse Prevention (INCA's standard). This will include patients diagnosed with nicotine dependence, who have achieved abstinence. Specific Objetctives: Evaluate the difference in the number of patients who continued abstinence of tobacco; Study the effectiveness MBRP in preventing lapses and relapses; Evaluate the effect of MBRP on the craving and its association with smoking cessation; Evaluate the effect of MBRP in positive and negative affects and its association with smoking cessation; To investigate the association of levels of mindfulness with smoking cessation; Evaluate the effect of MBRP in depressive symptoms, and its possible association with smoking cessation; Evaluate the effect of MBRP in anxiety symptoms, and its possible association with smoking cessation. These will be assessed at baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the study, besides being subjected to evaluations of regularly planned maintenance in the protocol INCA. Screening instruments: Self Report Questionnaire (SRQ-20); Questionnaire of Smoking Urges (QSU); Hospital Anxiety and Depression Scale (HAD); Center for Epidemiologic Studies Depression Scale (CES-D); Five Facet Mindfulness Questionnaire (FFMQ); Smokerlyser (measuring CO); The Fagerstrom Test for Nicotine Dependence (FTND); Positive and Negative Affect Schedule (PANAS). For data analysis there will be used Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect of two types of intervention on the evolution of comorbidities and abstinence of patients. Context: Ambulatory benchmark to smoking cessation treatment in the city of Juiz de Fora, Minas Gerais, Brazil. Participants: • Inclusion: patients with a diagnosis of nicotine dependence;• Exclusion: dependence on other substances, psychiatric comorbidities, pregnant women. •Groups matched for gender, education level and dependence on tobacco level. This initial study will evaluate the feasibility of Mindfulness-Based Relapse Prevention in the context of the Brazilian Public Health system as a supplemental treatment on craving and smoking cessation.
Mindfulness-based approaches have more recently begun to be assessed and implemented for treatment of addiction. The Mindfulness-Based Relapse Prevention (MBRP) program, which integrates mindfulness practice with cognitive therapy approaches, has shown promising preliminary results in previous studies.
The purpose of the current study is to evaluate the effectiveness of the Mindfulness-Based Relapse Prevention program as an adjunct in the standard smoking cessation treatment instituted by the Ministry of Health in Brazil.
The study is a randomized clinical trial, with 60 patients diagnosed with nicotine dependence. 60 patients will participate in this study receiving treatment (instituted by the Ministry of Health in Brazil, through the Instituto Nacional do Câncer - INCA'S standard) randomized between two groups: the Experimental Group (EG), which will undergo eight sessions of MBRP; and the Control Group (CG) that will undergo eight sessions of the traditional model of Relapse Prevention (INCA's standard). This will include patients diagnosed with nicotine dependence, who have achieved abstinence. Specific Objetctives: Evaluate the difference in the number of patients who continued abstinence of tobacco; Study the effectiveness MBRP in preventing lapses and relapses; Evaluate the effect of MBRP on the craving and its association with smoking cessation; Evaluate the effect of MBRP in positive and negative affects and its association with smoking cessation; To investigate the association of levels of mindfulness with smoking cessation; Evaluate the effect of MBRP in depressive symptoms, and its possible association with smoking cessation; Evaluate the effect of MBRP in anxiety symptoms, and its possible association with smoking cessation. These will be assessed at baseline (T0) and four other times: 1 (T1), 3 (T2), 6 (T3) and 12 months (T4) after the initiation of the study, besides being subjected to evaluations of regularly planned maintenance in the protocol INCA. Screening instruments: Self Report Questionnaire (SRQ-20); Questionnaire of Smoking Urges (QSU); Hospital Anxiety and Depression Scale (HAD); Center for Epidemiologic Studies Depression Scale (CES-D); Five Facet Mindfulness Questionnaire (FFMQ); Smokerlyser (measuring CO); The Fagerstrom Test for Nicotine Dependence (FTND); Positive and Negative Affect Schedule (PANAS). For data analysis there will be used Analysis of Variance with Repeated Measures and Longitudinal Logistic Regression, in order to evaluate the effect of two types of intervention on the evolution of comorbidities and abstinence of patients. Context: Ambulatory benchmark to smoking cessation treatment in the city of Juiz de Fora, Minas Gerais, Brazil. Participants: • Inclusion: patients with a diagnosis of nicotine dependence;• Exclusion: dependence on other substances, psychiatric comorbidities, pregnant women. •Groups matched for gender, education level and dependence on tobacco level. This initial study will evaluate the feasibility of Mindfulness-Based Relapse Prevention in the context of the Brazilian Public Health system as a supplemental treatment on craving and smoking cessation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: