Clinical trial NCT02645838: Motivational Interviewing for Smoking Cessation
Official title: Motivational Interviewing Versus Brief Advice for Smoking Cessation in General Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: Motivational Interviewing
Smoking Cessation
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether or not motivational interviewing is effective in smoking cessation at general practice setting in China.

Detailed description: OBJECTIVES:

• To compare the effectiveness of motivational interviewing versus brief advice by conducting a randomized controlled trial in General Practice Setting in China.

OUTLINE:

This is a randomized controlled study. Patients are randomized to either the intervention arm or the control arm.

• Arm I (intervention): Patients will be given a 20 minutes personal talk in the family physician's office during the visit. The family physicians will determine the stage of change in smoking cessation (precontemplative, contemplative, action, maintenance and relapse) and use the motivational interviewing skills during the talk. The motivational interviewing skills include expressing empathy, developing discrepancy, rolling with resistance, supporting self efficacy. Up to six phone calls will be given to the patients during the follow-up, using the motivational interviewing skill.

• Arm II (control): Patients will receive brief advice for smoking cessation, lasting approximately 5 minutes. The risks of smoking and the advantages of quitting will be explained. The information provided during the talk will be standardized. No phone call will be given during the follow-up.

Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18 and 80 years.
2. Any person who replies "Yes" when asked "Do you smoke?".
3. Agree to participate the trial and be followed for at least one year.

Exclusion Criteria:

1. With severe mental illness, serious drug dependent patients.
2. Cannot understand conversation or cannot communicate, such as deafness or dementia.
3. Cannot be followed up for one year, such as not likely survive for more than one year.

Primary outcomes:
measure: 1 week point prevalence abstinence (PPA)
timeFrame: Self-reported PPA at 1 week follow-up
Secondary outcomes:
measure: 1 month PPA
timeFrame: Self-reported 7-day PPA at 1 month follow-up
measure: 3 month PPA
timeFrame: Self-reported 7-day PPA at 3 month follow-up
measure: 6 month PPA
timeFrame: Self-reported 7-day PPA at 6 month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: School of General Practice and Continuing Education, Capital Medical University
name: Yafang Huang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bock BC, Papandonatos GD, de Dios MA, Abrams DB, Azam MM, Fagan M, Sweeney PJ, Stein MD, Niaura R. Tobacco cessation among low-income smokers: motivational enhancement and nicotine patch treatment. Nicotine Tob Res. 2014 Apr;16(4):413-22. doi: 10.1093/ntr/ntt166. Epub 2013 Oct 30.
citation: Borrelli B, Novak S, Hecht J, Emmons K, Papandonatos G, Abrams D. Home health care nurses as a new channel for smoking cessation treatment: outcomes from project CARES (Community-nurse Assisted Research and Education on Smoking). Prev Med. 2005 Nov-Dec;41(5-6):815-21. doi: 10.1016/j.ypmed.2005.08.004. Epub 2005 Sep 22.
citation: Davis MF, Shapiro D, Windsor R, Whalen P, Rhode R, Miller HS, Sechrest L. Motivational interviewing versus prescriptive advice for smokers who are not ready to quit. Patient Educ Couns. 2011 Apr;83(1):129-33. doi: 10.1016/j.pec.2010.04.024.
citation: Glasgow RE, Whitlock EP, Eakin EG, Lichtenstein E. A brief smoking cessation intervention for women in low-income planned parenthood clinics. Am J Public Health. 2000 May;90(5):786-9. doi: 10.2105/ajph.90.5.786.
citation: Mantler T, Irwin JD, Morrow D. Motivational interviewing and smoking behaviors: a critical appraisal and literature review of selected cessation initiatives. Psychol Rep. 2012 Apr;110(2):445-60. doi: 10.2466/02.06.13.18.PR0.110.2.445-460.
citation: Miller RW, Rollnick S. Motivational Interviewing: Preparing people to change addictive behavior. New York: Guilford Press; 1991.