Effectiveness of Mindfulness Based Relapse Prevention for Tobacco Dependents

NCT02327104 | Completed

• 1 other identifier: PROCESSO FAPESP 2013/02316-5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Keywords

mindfulness; tobacco dependence; relapse prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in smoking urges measured with the self report questionnaire: Questionnaire of Smoking Urges (QSU)

  baseline and twelve months

• Change in Symptoms of Anxiety measured through the The Hospital Anxiety and Depression Scale (HAD)

  baseline and twelve months

• Change in Symptoms of Depression measured through the Centre for Epidemiologic Studies Depression Scale (CES-D)

  baseline and twelve months

• change in Self report Mindfulness level measured with the self report questionnaire Five Facet Mindfulness Questionnaire (FFMQ)

  baseline and twelve months

• Maintenance of Abstinence measured by a Bedfont Micro Smokerlyser - CO monitor

  baseline and twelve months.

Study Arms (2)

Mindfulness Based Relapse Prevention

EXPERIMENTAL

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.

Behavioral: Mindfulness Based Relapse Prevention

Brazilian Ministry of Health Protocol

OTHER

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.

Behavioral: Mindfulness Based Relapse Prevention; Other: Brazilian Ministry of Health Protocol

Interventions

Mindfulness Based Relapse Prevention 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; Mindfulness Based Relapse Prevention

Brazilian Ministry of Health Protocol OTHER

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

Brazilian Ministry of Health Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Dependence on other substances;
• Psychiatric comorbidities;
• Pregnant women.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Drug Dependency Unit of the Federal University of São Paulo

São Paulo, 04024-003, Brazil

Location

Related Publications (2)

• 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.

  PMID: 35420700 DERIVED

• 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.

  PMID: 32222767 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ana Regina Noto, Doctor

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: December 30, 2014
• Study Start: October 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

BR (1)