Smoking CessationNCT02645838
Motivational Interviewing for Smoking Cessation
A study testing Motivational interviewing in people with Smoking Cessation, run by Capital Medical University.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2018
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 80 years.
- Any person who replies "Yes" when asked "Do you smoke?".
- Agree to participate the trial and be followed for at least one year.
Who cannot join
- With severe mental illness, serious drug dependent patients.
- Cannot understand conversation or cannot communicate, such as deafness or dementia.
- Cannot be followed up for one year, such as not likely survive for more than one year.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Motivational Interviewing Versus Brief Advice for Smoking Cessation in General Practice
The purpose of this study is to determine whether or not motivational interviewing is effective in smoking cessation at general practice setting in China.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Motivational interviewing
- Keywords
- Motivational Interviewing, Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
- Structural motivational interviewing for one section (about 20 mins)，provided by family physician;2. Follow-up telephone call，provided by family physician.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing group | Experimental | 1. Structural motivational interviewing for one section (about 20 mins)，provided by family physician
2. Follow-up telephone call，provided by family physician Receives: Behavioral: Motivational interviewing |
| Brief advice group | No intervention | Brief advice without motivational interviewing (about 5 mins), provided by family physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 week point prevalence abstinence (PPA)
Validation: exhaled carbon monoxide (CO) (< 10 ppm)
Measured: Self-reported PPA at 1 week follow-up
Secondary outcomes (3)
1 month PPA
Validation: exhaled CO (< 10 ppm)
Measured: Self-reported 7-day PPA at 1 month follow-up
3 month PPA
Validation: exhaled CO (< 10 ppm)
Measured: Self-reported 7-day PPA at 3 month follow-up
6 month PPA
Validation: exhaled CO (< 10 ppm)
Measured: Self-reported 7-day PPA at 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yafang Huang, Capital Medical University
- Investigators
- Yafang Huang, PHD, Principal investigator, School of General Practice and Continuing Education, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645838
- Sponsor's protocol ID
- CMUGP
- Status last verified
- Jan 2016
- First submitted
- 24 Dec 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual patient data will be available.
Publications
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.
PubMed 24174612Borrelli 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.
PubMed 16182355Davis 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.
PubMed 20627440Glasgow 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.
PubMed 10800431Mantler 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.
PubMed 22662398Miller RW, Rollnick S. Motivational Interviewing: Preparing people to change addictive behavior. New York: Guilford Press; 1991.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing Versus Brief Advice for Smoking Cessation in General Practice
- ClinicalTrials.gov ID
- NCT02645838
- Acronym / sponsor ID
- CMUGP
- Conditions
- Smoking Cessation
- Keywords
- Motivational Interviewing, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 5 Jan 2016 (estimated)
- 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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing group | Experimental | Behavioral: Motivational interviewing1. Structural motivational interviewing for one section (about 20 mins)，provided by family physician 2. Follow-up telephone call，provided by family physician |
| Brief advice group | No intervention | –Brief advice without motivational interviewing (about 5 mins), provided by family physician |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 80 years.
- Any person who replies "Yes" when asked "Do you smoke?".
- Agree to participate the trial and be followed for at least one year.
Key exclusion criteria (3 listed)
- With severe mental illness, serious drug dependent patients.
- Cannot understand conversation or cannot communicate, such as deafness or dementia.
- Cannot be followed up for one year, such as not likely survive for more than one year.
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 interviewing1. Structural motivational interviewing for one section (about 20 mins)，provided by family physician;2. Follow-up telephone call，provided by family physician. | Behavioural | Motivational interviewing group |
Primary outcome
1 week point prevalence abstinence (PPA)
Time frame: Self-reported PPA at 1 week follow-up
Validation: exhaled carbon monoxide (CO) (< 10 ppm)
3 secondary outcomes
1 month PPA
Time frame: Self-reported 7-day PPA at 1 month follow-up
3 month PPA
Time frame: Self-reported 7-day PPA at 3 month follow-up
6 month PPA
Time frame: Self-reported 7-day PPA at 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Background: PubMed 24174612Bock 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.
- Background: PubMed 16182355Borrelli 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.
- Background: PubMed 20627440Davis 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.
- Background: PubMed 10800431Glasgow 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.
- Background: PubMed 22662398Mantler 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.
- BackgroundMiller RW, Rollnick S. Motivational Interviewing: Preparing people to change addictive behavior. New York: Guilford Press; 1991.
- Individual participant dataSharing planned: Yes. Individual patient data will be available.
Related trials for Smoking Cessation
Not yet recruitingPhase 3
iCanQuit Smoking Cessation Among Hispanic Adults
Cigarette Smoking-Related Carcinoma
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
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.
Yafang Huang, PHD principal investigator
School of General Practice and Continuing Education, Capital Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Smoking Cessation, run by Capital Medical University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yafang Huang, PHD (+86-10-83911726, huangyafang85@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 week point prevalence abstinence (PPA) (time frame: Self-reported PPA at 1 week follow-up). 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 NCT02645838, which also lists 6 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 5 Jan 2016.