Motivational Interviewing for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Motivational Interviewing Versus Brief Advice for Smoking Cessation in General Practice

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02645838
• Other study ID #: CMUGP
• Status: Not yet recruiting
• Phase: N/A
• First received: December 24, 2015
• Last updated: January 3, 2016
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: January 2016
• Source: Capital Medical University
• Contact: Yafang Huang, PHD
• Phone: +86-10-83911726
• Email: huangyafang85[@]163.com
• Is FDA regulated: No
• Health authority: China: Capital Medical University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Motivational interviewing
1. Structural motivational interviewing for one section (about 20 mins),provided by family physician;2. Follow-up telephone call,provided by family physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

References & Publications (6)

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. — View 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. Epub 2005 Sep 22. — View 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. — View 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. — View 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. Review. — View Citation

Miller RW, Rollnick S. Motivational Interviewing: Preparing people to change addictive behavior. New York: Guilford Press; 1991.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 week point prevalence abstinence (PPA)	Validation: exhaled carbon monoxide (CO) (< 10 ppm)	Self-reported PPA at 1 week follow-up	No
Secondary	1 month PPA	Validation: exhaled CO (< 10 ppm)	Self-reported 7-day PPA at 1 month follow-up	No
Secondary	3 month PPA	Validation: exhaled CO (< 10 ppm)	Self-reported 7-day PPA at 3 month follow-up	No
Secondary	6 month PPA	Validation: exhaled CO (< 10 ppm)	Self-reported 7-day PPA at 6 month follow-up	No