NCT03221010

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

July 16, 2017

Last Update Submit

October 27, 2018

Conditions

Keywords

SmokingSmoking cessationMotivational InterviewingPrimary health careRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    Smoking cessation rate

    thirty days

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

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 InterviewingBehavioral: Traditional cognitive-behavioral approach

Traditional cognitive-behavioral approach

ACTIVE COMPARATOR

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

Interventions

Motivational Interview (MI) is a person-centered, communicative method whose purpose is to work and increase the user's motivation for behavior change.

Motivational Interviewing

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.

Also known as: cognitive-behavioral approach
Motivational InterviewingTraditional cognitive-behavioral approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokers.
  • Participate in group smoking treatment.

You may not qualify if:

  • Missing more than two sessions of the smoking group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nossa Senhora da Conceição Hospital

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

MeSH Terms

Conditions

Tobacco SmokingSmoking CessationSmoking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

BehaviorTobacco UseHealth Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

July 16, 2017

First Posted

July 18, 2017

Study Start

June 1, 2016

Primary Completion

July 1, 2017

Study Completion

June 1, 2018

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations