Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Evaluation of the Effectiveness of the Program of Mindfulness - Based Relapse Prevention (MBRP) as an Assistant Strategy to the Treatment of Tobacco Dependence
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.


Options:
A: Arm Label: Mindfulness Based Relapse Prevention; Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness Based Relapse Prevention | Arm Label: Brazilian Ministry of Health Protocol; Type: OTHER; Interventions: Behavioral: Mindfulness Based Relapse Prevention, Other: Brazilian Ministry of Health Protocol | Intervention Type: BEHAVIORAL; Name: Mindfulness Based Relapse Prevention; Assigned to Arm(s): Brazilian Ministry of Health Protocol, Mindfulness Based Relapse Prevention | Intervention Type: OTHER; Name: Brazilian Ministry of Health Protocol; Assigned to Arm(s): Brazilian Ministry of Health Protocol
B: Intervention Type: BEHAVIORAL; Name: Mindfulness Based Stress Reduction; Assigned to Arm(s): N/A
C: Arm Label: Mindfulness; Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness-based intervention | Arm Label: Sham meditation; Type: SHAM_COMPARATOR; Interventions: Behavioral: Sham meditation | Arm Label: Treatment as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Mindfulness-based intervention; Assigned to Arm(s): Mindfulness | Intervention Type: BEHAVIORAL; Name: Sham meditation; Assigned to Arm(s): Sham meditation
D: Arm Label: Experimental App; Type: EXPERIMENTAL; Interventions: Behavioral: Experimental App | Arm Label: Active comparator app; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Active Comparator App | Intervention Type: BEHAVIORAL; Name: Experimental App; Assigned to Arm(s): Experimental App | Intervention Type: BEHAVIORAL; Name: Active Comparator App; Assigned to Arm(s): Active comparator app

Answer: A