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 Addiction Treatment (MBAT); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Mindfulness-based Addiction Treatment, Behavioral: Self-Help guide, Drug: Nicotine Patch | Arm Label: iQuit Mindfully; Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness-based Addiction Treatment, Behavioral: iQuit Mindfully, Behavioral: Self-Help guide, Drug: Nicotine Patch | Intervention Type: BEHAVIORAL; Name: Mindfulness-based Addiction Treatment; Assigned to Arm(s): Mindfulness-based Addiction Treatment (MBAT), iQuit Mindfully | Intervention Type: BEHAVIORAL; Name: iQuit Mindfully; Assigned to Arm(s): iQuit Mindfully | Intervention Type: BEHAVIORAL; Name: Self-Help guide; Assigned to Arm(s): Mindfulness-based Addiction Treatment (MBAT), iQuit Mindfully | Intervention Type: DRUG; Name: Nicotine Patch; Assigned to Arm(s): Mindfulness-based Addiction Treatment (MBAT), iQuit Mindfully
B: 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
C: Arm Label: Mindfulness-Based Treatment Group (MBAT); Type: EXPERIMENTAL; Interventions: Behavioral: MBAT Group Therapy, Drug: Nicotine | Arm Label: Standard Care Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine, Behavioral: Group Therapy | Arm Label: Usual Care Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine, Behavioral: Individual Therapy | Intervention Type: BEHAVIORAL; Name: MBAT Group Therapy; Assigned to Arm(s): Mindfulness-Based Treatment Group (MBAT) | Intervention Type: DRUG; Name: Nicotine; Assigned to Arm(s): Mindfulness-Based Treatment Group (MBAT), Standard Care Group, Usual Care Group | Intervention Type: BEHAVIORAL; Name: Group Therapy; Assigned to Arm(s): Standard Care Group | Intervention Type: BEHAVIORAL; Name: Individual Therapy; Assigned to Arm(s): Usual Care Group
D: Arm Label: ACT; Type: EXPERIMENTAL; Interventions: Behavioral: ACT | Arm Label: CBT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: CBT | Intervention Type: BEHAVIORAL; Name: ACT; Assigned to Arm(s): ACT | Intervention Type: BEHAVIORAL; Name: CBT; Assigned to Arm(s): CBT

Answer: B