Effectiveness of Mindfulness Based Relapse Prevention for Tobacco Dependents

Tobacco Use Disorder Clinical Trial

— MBRP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327104
• Other study ID #: PROCESSO FAPESP 2013/02316-5
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: August 2016

Study information

• Verified date: July 2020
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of nicotine dependence;

• Patients currently smoking at least 10 cigarettes a day;

• Do not have any current major psychological disorders;

• Patients undergoing treatment for the first time

• Be willing to attend treatment and follow-up sessions, complete surveys and expired CO tests;

• Do not exhibit dependence on other drugs.

Exclusion Criteria:

• Dependence on other substances;

• Psychiatric comorbidities;

• Pregnant women.

Related Conditions & MeSH terms

• Recurrence
• Tobacco Use Disorder

Intervention

Behavioral:
• Mindfulness Based Relapse Prevention
The MBRP is an adjuvant treatment for people that have been treated for drug use related problems, and to prevent relapses.

Other:
• Brazilian Ministry of Health Protocol
The control group will receive maintenance sessions based on the Ministry of Health protocol after the four sessions of cognitive-behavioral approach.

Locations

Country	Name	City	State
Brazil	Drug Dependency Unit of the Federal University of São Paulo	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of São Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the maintenance of abstinence from Cessation of tobacco use through assessment interviews (self-report and CO monitor will be used), and the point prevalence	We will assess the maintenance of abstinence from tobacco use through assessment interviews (self-report and CO monitor will be used), and the point prevalence will be the primary outcome measure.	baseline and twelve months
Secondary	Change in smoking urges measured with the self report questionnaire: Questionnaire of Smoking Urges (QSU)	This will be measured with the self report questionnaire: Questionnaire of Smoking Urges (QSU)	baseline and twelve months
Secondary	Change in Symptoms of Anxiety measured through the The Hospital Anxiety and Depression Scale (HAD)	The symptoms of anxiety will be measured through the The Hospital Anxiety and Depression Scale (HAD)	baseline and twelve months
Secondary	Change in Symptoms of Depression measured through the Centre for Epidemiologic Studies Depression Scale (CES-D)	The symptoms of depression will be measured through the Centre for Epidemiologic Studies Depression Scale (CES-D)	baseline and twelve months
Secondary	change in Self report Mindfulness level measured with the self report questionnaire Five Facet Mindfulness Questionnaire (FFMQ)	This will be measured with the self report questionnaire Five Facet Mindfulness Questionnaire (FFMQ)	baseline and twelve months
Secondary	Maintenance of Abstinence measured by a Bedfont Micro Smokerlyser - CO monitor	Abstinence will be measured by a Bedfont Micro Smokerlyser - CO monitor, to support self-reports of smoking cessation.	baseline and twelve months.
Secondary	Tobacco Dependence measured through The Fagerstrom Test for Nicotine Dependence (FTND)	This will be measured through The Fagerstrom Test for Nicotine Dependence (FTND)	baseline and twelve months
Secondary	Change in Positive and Negative Affects measured through Positive and Negative Affect Scale (PANAS)	This will be measured through Positive and Negative Affect Scale (PANAS).	baseline and twelve months