NCT01188018

Brief Summary

The purpose of this study is to determine, among a sample of general adult smokers, the effectiveness of three different counseling interventions for motivating quit attempts among smokers not yet ready to quit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

August 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

1.7 years

First QC Date

August 24, 2010

Last Update Submit

July 3, 2012

Conditions

Keywords

SmokingSmoking CessationNicotine DependenceTobacco Use CessationHealth EducationPatient Education

Outcome Measures

Primary Outcomes (1)

  • Quit Attempt(s)

    Any time within 26 weeks

Secondary Outcomes (1)

  • Smoking Cessation

    7 days

Study Arms (3)

Brief Advice

ACTIVE COMPARATOR
Behavioral: Brief Advice (BA)

Motivational Interviewing

EXPERIMENTAL
Behavioral: Motivational Interviewing (MI)

Health Education

ACTIVE COMPARATOR
Behavioral: Health Education (HE)

Interventions

Participants in this arm will receive a single session of brief advice. A counselor will briefly discuss the risks associated with smoking.

Brief Advice

Subjects will receive 4 counseling sessions (over 18 weeks) in which their thoughts about their smoking will be discussed. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone(weeks 6 and 18).

Motivational Interviewing

Subjects will receive 4 counseling sessions (over 18 weeks)in which they will receive educational information about the risks of smoking and the benefits of quitting. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone (weeks 6 and 18).

Health Education

Eligibility Criteria

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

You may qualify if:

  • Age 18 years and older
  • Smoke at least once a day for the past 30 days
  • Are willing to participate in all study components
  • Sufficient language skills in English for counseling and assessments
  • Has a home address
  • Has a working phone number

You may not qualify if:

  • Pregnant or planning to become pregnant in the next 6 months
  • Currently using a smoking cessation medication
  • Currently participating in smoking cessation program
  • Motivated to quit smoking
  • Planning to quit smoking in the next 2 weeks
  • Lives in a home with someone currently enrolled in the study
  • Minor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Kansas City

Kansas City, Missouri, 64110, United States

Location

Related Publications (8)

  • 2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.

    PMID: 18807274BACKGROUND
  • Soria R, Legido A, Escolano C, Lopez Yeste A, Montoya J. A randomised controlled trial of motivational interviewing for smoking cessation. Br J Gen Pract. 2006 Oct;56(531):768-74.

    PMID: 17007707BACKGROUND
  • Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.

    PMID: 17716083BACKGROUND
  • Grobe JE, Goggin K, Harris KJ, Richter KP, Resnicow K, Catley D. Race moderates the effects of Motivational Interviewing on smoking cessation induction. Patient Educ Couns. 2020 Feb;103(2):350-358. doi: 10.1016/j.pec.2019.08.023. Epub 2019 Aug 18.

  • Bani-Yaghoub M, Elhomani A, Catley D. Effectiveness of motivational interviewing, health education and brief advice in a population of smokers who are not ready to quit. BMC Med Res Methodol. 2018 Jun 13;18(1):52. doi: 10.1186/s12874-018-0511-0.

  • Harris KJ, Bradley-Ewing A, Goggin K, Richter KP, Patten C, Williams K, Lee HS, Staggs VS, Catley D. Recruiting unmotivated smokers into a smoking induction trial. Health Educ Res. 2016 Jun;31(3):363-74. doi: 10.1093/her/cyw018. Epub 2016 Apr 13.

  • Catley D, Goggin K, Harris KJ, Richter KP, Williams K, Patten C, Resnicow K, Ellerbeck EF, Bradley-Ewing A, Lee HS, Moreno JL, Grobe JE. A Randomized Trial of Motivational Interviewing: Cessation Induction Among Smokers With Low Desire to Quit. Am J Prev Med. 2016 May;50(5):573-583. doi: 10.1016/j.amepre.2015.10.013. Epub 2015 Dec 23.

  • Catley D, Harris KJ, Goggin K, Richter K, Williams K, Patten C, Resnicow K, Ellerbeck E, Bradley-Ewing A, Malomo D, Liston R. Motivational Interviewing for encouraging quit attempts among unmotivated smokers: study protocol of a randomized, controlled, efficacy trial. BMC Public Health. 2012 Jun 19;12:456. doi: 10.1186/1471-2458-12-456.

Related Links

MeSH Terms

Conditions

SmokingTobacco UseTobacco Use DisorderSmoking CessationTobacco Use CessationHealth Education

Interventions

Crisis InterventionMotivational Interviewing

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Delwyn Catley, Ph.D.

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 25, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations