Effectiveness of Mindfulness Based Relapse Prevention for Tobacco Dependents

NCT ID: NCT02327104

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-08-31

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mindfulness Based Relapse Prevention

The Experimental Group (EG) will undergo eight sessions of MBRP after Brazilian Ministry of Health Protocol (BMHP) for Tobacco dependence treatment. MBRP Program: the first three sessions: focus on practicing mindful awareness and integrating mindfulness practices into daily life (body scan, sitting meditation, walking meditation); The next three sessions: emphasize acceptance of present experience and application of mindfulness practices to relapse prevention; The final two sessions: expand to include issues of self-care, support network, and lifestyle balance.

Group Type: EXPERIMENTAL

Mindfulness Based Relapse Prevention

Intervention Type: BEHAVIORAL

The MBRP is an adjuvant treatment for people that have been treated for drug use related problems, and to prevent relapses.

Brazilian Ministry of Health Protocol

The Control Group (CG) is undergo the protocol of the Brazilian Ministry of Health Protocol (BMHP): clinical evaluation, four sessions of cognitive-behavioral approach and Nicotine Replacement Therapy and/or Bupropion as needed, as the Experimental Group. And during the eight sessions of MBRP (EG) both groups (EG and CG) are subjected to eight maintenance sessions of BMHP.

Group Type: OTHER

Mindfulness Based Relapse Prevention

Intervention Type: BEHAVIORAL

The MBRP is an adjuvant treatment for people that have been treated for drug use related problems, and to prevent relapses.

Brazilian Ministry of Health Protocol

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ana Regina Noto

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Regina Noto, Doctor

Role: STUDY_DIRECTOR

Federal University of São Paulo

Locations

Drug Dependency Unit of the Federal University of São Paulo

São Paulo, , Brazil

Countries

Brazil

References

Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

Reference Type: DERIVED

PMID: 35420700 (View on PubMed)

Weiss de Souza IC, Kozasa EH, Bowen S, Richter KP, Sartes LMA, Colugnati FAB, Noto AR. Effectiveness of Mindfulness-Based Relapse Prevention Program as an Adjunct to the Standard Treatment for Smoking: A Pragmatic Design Pilot Study. Nicotine Tob Res. 2020 Aug 24;22(9):1605-1613. doi: 10.1093/ntr/ntaa057.

Reference Type: DERIVED

PMID: 32222767 (View on PubMed)

Other Identifiers

PROCESSO FAPESP 2013/02316-5

Identifier Type: -

Identifier Source: org_study_id