Smoking, TobaccoMITGNCT03221010
Use of the Motivational Interviewing in the Treatment of Smokers in Groups in Primary Health Care
A study testing Motivational Interviewing and Traditional cognitive-behavioral approach in people with Smoking, Tobacco and Smoking Cessation, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Tobacco, Smoking Cessation
- What is being tested?
- Motivational Interviewing and Traditional cognitive-behavioral approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smokers.
- Participate in group smoking treatment.
Who cannot join
- Missing more than two sessions of the smoking group.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Nossa Senhora da Conceição Hospital
Porto Alegre, Rio Grande do Sul, 91350-200
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking, Tobacco, Smoking Cessation
- Being tested
- Motivational Interviewing, Traditional cognitive-behavioral approach
- Keywords
- Smoking, Smoking cessation, Motivational Interviewing, Primary health care, Randomized clinical trial
- Medical subject headings
- Tobacco Smoking, Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Motivational Interview (MI) is a person-centered, communicative method whose purpose is to work and increase the user's motivation for behavior change.
Traditional cognitive-behavioral approachBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motivational Interviewing; Behavioral: 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. Receives: Behavioral: Traditional cognitive-behavioral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Smoking cessation rate
Measured: thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study startJun 2016
- Primary completionJul 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Daniel Demétrio Faustino da Silva, Hospital Nossa Senhora da Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221010
- Sponsor's protocol ID
- HNSC-Tobacco Groups
- Acronym
- MITG
- Status last verified
- Oct 2018
- First submitted
- 16 Jul 2017
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Motivational Interviewing in the Cessation of Smoking in Groups in Primary Health Care Services: a Community Clinical Trial
- ClinicalTrials.gov ID
- NCT03221010
- Acronym / sponsor ID
- MITG / HNSC-Tobacco Groups
- Conditions
- Smoking, Tobacco, Smoking Cessation
- Keywords
- Smoking, Smoking cessation, Motivational Interviewing, Primary health care, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational Interviewing, Behavioral: Traditional cognitive-behavioral approachIntervention 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. |
| Traditional cognitive-behavioral approach | Active comparator | Behavioral: Traditional cognitive-behavioral approachControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Smokers.
- Participate in group smoking treatment.
Key exclusion criteria (1 listed)
- Missing more than two sessions of the smoking group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingMotivational Interview (MI) is a person-centered, communicative method whose purpose is to work and increase the user's motivation for behavior change. | Behavioural | Motivational Interviewing |
| Traditional cognitive-behavioral approachAlso: cognitive-behavioral approachThis 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. | Behavioural | Motivational Interviewing, Traditional cognitive-behavioral approach |
Primary outcome
Smoking cessation
Time frame: thirty days
Smoking cessation rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Smoking, Tobacco
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Traditional cognitive-behavioral approach in people with Smoking, Tobacco and Smoking Cessation, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation (time frame: thirty days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.