- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03219060
Motivational Interviewing for Nurses' Smoking Cessation
July 12, 2017 updated by: Agurtzane Mujika, Clinica Universidad de Navarra, Universidad de Navarra
Motivational Interviewing as a Smoking Cessation Strategy With Nurses: an Exploratory Randomized Controlled Trial Following the MRC's Framework for Complex Interventions
This study's objective was to test the efficacy, acceptability and feasibility of a motivational interviewing (MI) based smoking cessation intervention with nurses.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Despite the important role that health professionals have in reducing tobacco use, many have a smoking habit themselves.
The prevalence of smoking is particularly high among nurses.
A smoking cessation intervention for nurses who smoked, based on MI, was designed and evaluated following the UK Medical Research Council's (MRC) framework for complex interventions.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Navarra
-
Pamplona, Navarra, Spain, 31008
- Clinica Universidad de Navarra
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Nurses who were smokers
- Nurses willing to participate in the study
Exclusion Criteria:
- Nurses who were pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
MI based four individual sessions
|
Intervention, four one-to-one sessions on an approximately weekly basis, with 3 components: MI context, toolkit, and relapse prevention.
The sessions were embedded in a MI context and followed two phases: exploratory and resolutive.
The former explored the potential ambivalence that nurses experienced and constructed motivation for change; the latter reinforced the decision to quit and developed a change plan.
Participants could choose over a range of tools: some more helpful in the exploratory phase (i.e.
decisional balance sheet) and others in the resolutive phase (i.e.
problem solving skills).
The third component was directed at maintenance strategies.
The therapy stayed with the nurses in terms of where they were in relation to they readiness for change.
|
Active Comparator: Control group
Brief advice following 5As
|
Brief advice based on 5As
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemically verified smoking cessation
Time Frame: Following nurses' self-report of quitting (end of intervention (1 month) to 3 month follow-up)
|
Urine sample collected in nurses who self-reported being abstinent for at least one week
|
Following nurses' self-report of quitting (end of intervention (1 month) to 3 month follow-up)
|
Participant satisfaction
Time Frame: End of intervention (1 month)
|
Client Satisfaction Questionnaire (CHQ-8) (Roberts et al 1984)
|
End of intervention (1 month)
|
Duration of sessions
Time Frame: End of intervention (1 month)
|
Following researcher's diary records
|
End of intervention (1 month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Mean cigarettes smoked
Time Frame: Baseline, end of intervention (1 month) and 3 month follow-up
|
Number of cigarettes smoked
|
Baseline, end of intervention (1 month) and 3 month follow-up
|
Changes in Stages of change
Time Frame: Baseline, end of intervention (1 month) and 3 month follow-up
|
Assessment of desire and readiness to quit smoking (Prochaska and Velicer, 1997)
|
Baseline, end of intervention (1 month) and 3 month follow-up
|
Changes in Nicotine Dependence
Time Frame: Baseline, end of intervention (1 month) and 3 month follow-up
|
Assessment of nicotine dependence using the Fagerström Test for Nicotine Dependence (FTND) (Becoña and Vazquez, 1998)
|
Baseline, end of intervention (1 month) and 3 month follow-up
|
Changes in Self-efficacy
Time Frame: Baseline, end of intervention (1 month) and 3 month follow-up
|
Assessment of general self-efficacy using GSE scale (Scholz et al, 2002)
|
Baseline, end of intervention (1 month) and 3 month follow-up
|
Changes in Depression score
Time Frame: Baseline, end of intervention (1 month) and 3 month follow-up
|
Depression screening using the Patient Health Questionnaire (PHQ-9) (Kroenke et al 2001)
|
Baseline, end of intervention (1 month) and 3 month follow-up
|
Adherence to MI
Time Frame: End of intervention (1 month)
|
Assessment of intervention fidelity and adherence to MI principles using Motivational Interviewing Treatment Integrity (MITI) Code (Moyers et al 2005)
|
End of intervention (1 month)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Agurtzane Mujika, PhD, University of Navarra
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mujika A, Arantzamendi M, Lopez-Dicastillo O, Forbes A. Health professionals' personal behaviours hindering health promotion: A study of nurses who smoke. J Adv Nurs. 2017 Nov;73(11):2633-2641. doi: 10.1111/jan.13343. Epub 2017 Jun 21.
- Duaso MJ, Bakhshi S, Mujika A, Purssell E, While AE. Nurses' smoking habits and their professional smoking cessation practices. A systematic review and meta-analysis. Int J Nurs Stud. 2017 Feb;67:3-11. doi: 10.1016/j.ijnurstu.2016.10.011. Epub 2016 Nov 2.
- Duaso MJ, McDermott MS, Mujika A, Purssell E, While A. Do doctors' smoking habits influence their smoking cessation practices? A systematic review and meta-analysis. Addiction. 2014 Nov;109(11):1811-23. doi: 10.1111/add.12680. Epub 2014 Aug 5.
- Mujika A, Forbes A, Canga N, de Irala J, Serrano I, Gasco P, Edwards M. Motivational interviewing as a smoking cessation strategy with nurses: an exploratory randomised controlled trial. Int J Nurs Stud. 2014 Aug;51(8):1074-82. doi: 10.1016/j.ijnurstu.2013.12.001. Epub 2013 Dec 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
July 10, 2017
First Submitted That Met QC Criteria
July 12, 2017
First Posted (Actual)
July 17, 2017
Study Record Updates
Last Update Posted (Actual)
July 17, 2017
Last Update Submitted That Met QC Criteria
July 12, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pending (Other Identifier: Pending)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
-
Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States
Clinical Trials on Motivational interviewing for smoking cessation in nurses
-
Hospital Universitari Vall d'Hebron Research InstituteDepartment of Health, Generalitat de Catalunya; GETTEII ( Grupo Enfermero de...Completed
-
Butler HospitalCompletedSmoking CessationUnited States
-
Boston UniversityThe Miriam Hospital; Harvard School of Public Health (HSPH); Boston Housing AuthorityCompletedTobacco CessationUnited States
-
Norwegian Institute of Public HealthOslo University Hospital; University Hospital of North Norway; Helse Stavanger... and other collaboratorsUnknown
-
Virginia Commonwealth UniversityVirginia Tobacco Settlement Foundation (VTSF)Completed
-
Oulu University HospitalActive, not recruiting
-
Oregon Research Behavioral Intervention Strategies...RecruitingTobacco UseUnited States
-
University of RochesterRobert Wood Johnson Foundation; Truth InitiativeCompletedSmoking Cessation | Health Care Quality, Access, and EvaluationUnited States
-
Henry Ford Health SystemCompletedObesity | Diabetes | Overweight | Blood Pressure | HypercholesteremiaUnited States
-
Morgan State UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedTobacco Use | Cigarette SmokingUnited States