Use of the Motivational Interviewing in the Treatment of Smokers in Groups in Primary Health Care (MITG)

Evaluation of the Effectiveness of the Motivational Interviewing in the Cessation of Smoking in Groups in Primary Health Care Services: a Community Clinical Trial

The objective of this study is to evaluate the efficacy of Motivational Interview (MI) on the smoking cessation rates of the smoking groups performed by the primary care teams of the Conceição Hospitalar Group, Porto Alegre, Brasil, and also whether there is an increase in the completion rate of the groups.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Smoking, Tobacco
• Intervention / Treatment: Behavioral: Motivational Interviewing; Behavioral: Traditional cognitive-behavioral approach

Detailed Description

Smoking is the leading cause of preventable death and a major public health problem worldwide. Primary health care is a strategic setting in the treatment of this problem. The objective of this study is to evaluate the efficacy of Motivational Interview (MI) on the smoking cessation rates of the smoking groups performed by the primary care teams of the Conceição Hospitalar Group, Porto Alegre, Brasil, and also whether there is an increase in the completion rate of the groups. Methodology: A randomized community trial was carried out in the 12 units of this service, starting in July 2016, with randomization by cluster, where the intervention group received an 8-hour training in MI in order to associate the technique with the conventional approach, while the units of the control group used only the conventional approach.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 91350-200
      • Nossa Senhora da Conceição Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Smokers.
• Participate in group smoking treatment.

Exclusion Criteria:

• Missing more than two sessions of the smoking group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interviewing; Intervention Group: in this group, composed of 6 randomized Basic Health Units, the professionals who coordinate the smoking groups will receive the training for the use of the Motivational Interviewing as an additional resource to the work of motivation and cognitive-behavioral approach usually performed in the groups, however , With an approach based on Motivational Interviewing.	Behavioral: Motivational Interviewing; Motivational Interview (MI) is a person-centered, communicative method whose purpose is to work and increase the user's motivation for behavior change.; Behavioral: Traditional cognitive-behavioral approach; This approach aims to combine cognitive interventions in the training of behavioral skills in patients, developing strategies to cope with the problem and detecting situations of risk, mobilizing the subject for his own process of change. Helps correct cognitive dysfunctions and behavioral changes in specific situations.; Other Names: cognitive-behavioral approach
Active Comparator: Traditional cognitive-behavioral approach; Control Group: in this group composed of the remaining 6 Randomized Basic Health Units, professionals will use only the traditional cognitive-behavioral approach advocated by the Brazilian Ministry of Health's smoking program.	Behavioral: Traditional cognitive-behavioral approach; This approach aims to combine cognitive interventions in the training of behavioral skills in patients, developing strategies to cope with the problem and detecting situations of risk, mobilizing the subject for his own process of change. Helps correct cognitive dysfunctions and behavioral changes in specific situations.; Other Names: cognitive-behavioral approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation	Smoking cessation rate	thirty days

Collaborators and Investigators

• Sponsor: Hospital Nossa Senhora da Conceicao
• Collaborators: Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: July 16, 2017
• First Submitted That Met QC Criteria: July 16, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 27, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Randomized clinical trial; Smoking; Primary health care; Smoking cessation
• Other Study ID Numbers: HNSC-Tobacco Groups

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No