- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02327104
Effectiveness of Mindfulness Based Relapse Prevention for Tobacco Dependents (MBRP)
Evaluation of the Effectiveness of the Program of Mindfulness - Based Relapse Prevention (MBRP) as an Assistant Strategy to the Treatment of Tobacco Dependence
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo, Brazil, 04024-003
- Drug Dependency Unit of the Federal University of São Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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The MBRP is an adjuvant treatment for people that have been treated for drug use related problems, and to prevent relapses.
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Other: 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.
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The MBRP is an adjuvant treatment for people that have been treated for drug use related problems, and to prevent relapses.
The control group will receive maintenance sessions based on the Ministry of Health protocol after the four sessions of cognitive-behavioral approach.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: baseline and twelve months
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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.
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baseline and twelve months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in smoking urges measured with the self report questionnaire: Questionnaire of Smoking Urges (QSU)
Time Frame: baseline and twelve months
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This will be measured with the self report questionnaire: Questionnaire of Smoking Urges (QSU)
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baseline and twelve months
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Change in Symptoms of Anxiety measured through the The Hospital Anxiety and Depression Scale (HAD)
Time Frame: baseline and twelve months
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The symptoms of anxiety will be measured through the The Hospital Anxiety and Depression Scale (HAD)
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baseline and twelve months
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Change in Symptoms of Depression measured through the Centre for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: baseline and twelve months
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The symptoms of depression will be measured through the Centre for Epidemiologic Studies Depression Scale (CES-D)
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baseline and twelve months
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change in Self report Mindfulness level measured with the self report questionnaire Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: baseline and twelve months
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This will be measured with the self report questionnaire Five Facet Mindfulness Questionnaire (FFMQ)
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baseline and twelve months
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Maintenance of Abstinence measured by a Bedfont Micro Smokerlyser - CO monitor
Time Frame: baseline and twelve months.
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Abstinence will be measured by a Bedfont Micro Smokerlyser - CO monitor, to support self-reports of smoking cessation.
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baseline and twelve months.
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Tobacco Dependence measured through The Fagerstrom Test for Nicotine Dependence (FTND)
Time Frame: baseline and twelve months
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This will be measured through The Fagerstrom Test for Nicotine Dependence (FTND)
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baseline and twelve months
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Change in Positive and Negative Affects measured through Positive and Negative Affect Scale (PANAS)
Time Frame: baseline and twelve months
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This will be measured through Positive and Negative Affect Scale (PANAS).
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baseline and twelve months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ana Regina Noto, Doctor, Federal University of São Paulo
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROCESSO FAPESP 2013/02316-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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