NCT03219060

Brief Summary

This study's objective was to test the efficacy, acceptability and feasibility of a motivational interviewing (MI) based smoking cessation intervention with nurses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

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

August 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

July 10, 2017

Last Update Submit

July 12, 2017

Conditions

Keywords

Cognitive dissonanceMotivational interviewingHealth Professional roleNursesHealth PromotionLifestyleSmoking cessation

Outcome Measures

Primary Outcomes (3)

  • Biochemically verified smoking cessation

    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

    Client Satisfaction Questionnaire (CHQ-8) (Roberts et al 1984)

    End of intervention (1 month)

  • Duration of sessions

    Following researcher's diary records

    End of intervention (1 month)

Secondary Outcomes (6)

  • Changes in Mean cigarettes smoked

    Baseline, end of intervention (1 month) and 3 month follow-up

  • Changes in Stages of change

    Baseline, end of intervention (1 month) and 3 month follow-up

  • Changes in Nicotine Dependence

    Baseline, end of intervention (1 month) and 3 month follow-up

  • Changes in Self-efficacy

    Baseline, end of intervention (1 month) and 3 month follow-up

  • Changes in Depression score

    Baseline, end of intervention (1 month) and 3 month follow-up

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

MI based four individual sessions

Behavioral: Motivational interviewing for smoking cessation in nurses

Control group

ACTIVE COMPARATOR

Brief advice following 5As

Behavioral: Brief advice

Interventions

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.

Intervention group
Brief adviceBEHAVIORAL

Brief advice based on 5As

Control group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses who were smokers
  • Nurses willing to participate in the study

You may not qualify if:

  • Nurses who were pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (4)

  • 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.

    PMID: 28543954BACKGROUND
  • 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.

    PMID: 27880873BACKGROUND
  • 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.

    PMID: 25041084BACKGROUND
  • 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.

MeSH Terms

Conditions

Health BehaviorSmoking Cessation

Interventions

Motivational InterviewingNursesCrisis Intervention

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Agurtzane Mujika, PhD

    University of Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Agurtzane Mujika

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 17, 2017

Study Start

August 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 17, 2017

Record last verified: 2017-07

Locations