Health BehaviorNCT03219060
Motivational Interviewing for Nurses' Smoking Cessation
A study testing Motivational interviewing for smoking cessation in nurses and Brief advice in people with Health Behavior and Smoking Cessation, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
This study's objective was to test the efficacy, acceptability and feasibility of a motivational interviewing (MI) based smoking cessation intervention with nurses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Smoking Cessation, Health Personnel Attitude
- What is being tested?
- Motivational interviewing for smoking cessation in nurses and Brief advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2010to Jul 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nurses who were smokers
- Nurses willing to participate in the study
Who cannot join
- Nurses who were pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Motivational interviewing for smoking cessation in nurses, Brief advice
- Keywords
- Cognitive dissonance, Motivational interviewing, Health Professional role, Nurses, Health Promotion, Lifestyle, Smoking cessation
- Medical subject headings
- Health Behavior, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing for smoking cessation in nursesBehavioural
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.
Brief adviceBehavioural
Brief advice based on 5As
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | MI based four individual sessions Receives: Behavioral: Motivational interviewing for smoking cessation in nurses |
| Control group | Active comparator | Brief advice following 5As Receives: Behavioral: Brief advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically verified smoking cessation
Urine sample collected in nurses who self-reported being abstinent for at least one week
Measured: Following nurses' self-report of quitting (end of intervention (1 month) to 3 month follow-up)
Participant satisfaction
Client Satisfaction Questionnaire (CHQ-8) (Roberts et al 1984)
Measured: End of intervention (1 month)
Duration of sessions
Following researcher's diary records
Measured: End of intervention (1 month)
Secondary outcomes (6)
Changes in Mean cigarettes smoked
Number of cigarettes smoked
Measured: Baseline, end of intervention (1 month) and 3 month follow-up
Changes in Stages of change
Assessment of desire and readiness to quit smoking (Prochaska and Velicer, 1997)
Measured: Baseline, end of intervention (1 month) and 3 month follow-up
Changes in Nicotine Dependence
Assessment of nicotine dependence using the Fagerström Test for Nicotine Dependence (FTND) (Becoña and Vazquez, 1998)
Measured: Baseline, end of intervention (1 month) and 3 month follow-up
Changes in Self-efficacy
Assessment of general self-efficacy using GSE scale (Scholz et al, 2002)
Measured: Baseline, end of intervention (1 month) and 3 month follow-up
Changes in Depression score
Depression screening using the Patient Health Questionnaire (PHQ-9) (Kroenke et al 2001)
Measured: Baseline, end of intervention (1 month) and 3 month follow-up
Adherence to MI
Assessment of intervention fidelity and adherence to MI principles using Motivational Interviewing Treatment Integrity (MITI) Code (Moyers et al 2005)
Measured: End of intervention (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study startAug 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Navarra
- Responsible party
- Principal investigator, Agurtzane Mujika, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Agurtzane Mujika, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219060
- Sponsor's protocol ID
- PENDING
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 17 Jul 2017
- Results posted
- No
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.
PubMed 28543954Duaso 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.
PubMed 27880873Duaso 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.
PubMed 25041084Mujika 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.
PubMed 24433609
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing as a Smoking Cessation Strategy With Nurses: an Exploratory Randomized Controlled Trial Following the MRC's Framework for Complex Interventions
- ClinicalTrials.gov ID
- NCT03219060
- Acronym / sponsor ID
- PENDING
- Keywords
- Cognitive dissonance, Motivational interviewing, Health Professional role, Nurses, Health Promotion, Lifestyle, Smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Government of Navarra
- Study start
- Aug 2010 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 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.
This study's objective was to test the efficacy, acceptability and feasibility of a motivational interviewing (MI) based smoking cessation intervention with nurses.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Motivational interviewing for smoking cessation in nursesMI based four individual sessions |
| Control group | Active comparator | Behavioral: Brief adviceBrief advice following 5As |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Nurses who were smokers
- Nurses willing to participate in the study
Key exclusion criteria (1 listed)
- Nurses who were pregnant
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 interviewing for smoking cessation in nursesIntervention, 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. | Behavioural | Intervention group |
| Brief adviceBrief advice based on 5As | Behavioural | Control group |
Primary outcome
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
Participant satisfaction
Time frame: End of intervention (1 month)
Client Satisfaction Questionnaire (CHQ-8) (Roberts et al 1984)
Duration of sessions
Time frame: End of intervention (1 month)
Following researcher's diary records
6 secondary outcomes
Changes in Mean cigarettes smoked
Time frame: 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
Changes in Nicotine Dependence
Time frame: 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
Changes in Depression score
Time frame: Baseline, end of intervention (1 month) and 3 month follow-up
Adherence to MI
Time frame: End of intervention (1 month)
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 17 Jul 2017.
- Background: PubMed 28543954Mujika 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.
- Background: PubMed 27880873Duaso 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.
- Background: PubMed 25041084Duaso 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.
- Results publication: PubMed 24433609Mujika 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.
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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.
Agurtzane Mujika, PhD principal investigator
University of Navarra
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 for smoking cessation in nurses and Brief advice in people with Health Behavior and Smoking Cessation, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 17 Jul 2017. 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 Spain. 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?
Biochemically verified smoking cessation (time frame: Following nurses' self-report of quitting (end of intervention (1 month) to 3 month follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219060, which also lists 4 linked publications.
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 17 Jul 2017.