- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06148909
Small Talk Intervention With MI for Smoking Cessation
A Pilot Study on Small Talk Intervention With MI in Assisting Smokers to Quit
The goal of this pilot study is to examine the effectiveness of the STMI in promoting abstinence in unmotivated smokers. The main questions it aims to answer are:
- Do unmotivated smokers treated with STMI exhibit higher abstinence rate than those in the control group?
- Do unmotivated smokers treated with STMI show higher intention to quit than those in the control group?
- Do unmotivated smokers treated with STMI show higher smoking reduction rates than those in the control group?
- Do unmotivated smokers treated with STMI show lower level of depressive symptoms than those in the control group?
- Do unmotivated smokers treated with STMI show higher adherence than those in the control group?
- Does STMI show higher consent rates than those the control?
- How does STMI affect the smoking behaviors in unmotivated smokers?
Participants will be randomized to (1) STMI or (2) control group for smoking cessation services via telephone, and then be invited to join a semi-structured interview.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Two RAs with at least 1 year of experience in counseling or related work will be hired to deliver the intervention. The same RA will deliver the eight-session intervention weekly via telephone to the same participant within 2 months. The intervention contains eight sessions which is similar to that in YQL. Interventions will be delivered via telephone because YQL also used the same delivery mode to successfully contact and assist a considerable number of smokers to quit . Based on our team's experience in YQL, each session will last from 30 minutes to 1 hour.
In the first to third sessions, the RA will engage in small talk with the participants for 30 minutes. The RA will talk to the participants on the proposed topics including the weather, activities the participant engaged in last week and at weekends, music, food, and other hobbies, all of which were recommended in previous literature as topics that interest most people and create curiosity and enjoyment rather than animosity. From the fourth session onwards, the RA will add 30 minutes of MI about smoking cessation after engaging in small talk. During MI delivery, the RA will use core MI skills, including open-ended questions, affirmation, reflective listening, and summary, elicit-provide-elicit, evoking change talk, and roll with resistance to move the participants from engaging (first process of MI) to planning (last process of MI), as in YQL and other smoking cessation projects that use MI. The RA will aim to go through the engaging process in the fourth session, focusing process in the fifth session, focusing and evoking in the sixth session, and evoking and planning in the seventh and eighth sessions. When transitioning from small talk to MI, some simple transitional sentences are suggested, such as: "We have been talking for quite a while since our contact at the first time. Actually, I am quite interested in understanding your smoking behaviors. Do you mind talking with me about that?" If the participants refuse, the RA will continue to deliver small talk and repeat asking in the next session if the participants can move to talk about smoking or not.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ka Wai Katherine Lam, Phd
- Phone Number: 27666420
- Email: kw-katherine.lam@polyu.edu.hk
Study Locations
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Hong Kong,China
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Hong Kong, Hong Kong,China, Hong Kong, 0000
- Katherine Lam
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18-25 years old
- Have smoked any smoking products in the past 30 days
- do not intend to quit in the coming 30 days
- did not have a past-year quit attempt lasting for 24 hours or more
- are not currently in any smoking cessation programs
- are able to speak Cantonese and read Chinese
Exclusion Criteria:
- self-report having identified cognitive problems or psychosis, including schizophrenia, psychotic depression, and schizoaffective disorder will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Small Talk Motivational Interviewing (STMI)
during the 8 session of smoking cessation, the first three sessions will be used to do small talks with the participant.
And then from the fourth session onwards, the RA will add 30 minutes of MI about smoking cessation after engaging in small talk.
|
Combining small talks and skills on Motivational Interviewing in the smoking cessation services
|
|
No Intervention: Control (only MI)
Another two RA with at least one-year experience on counselling will be delivering the control group.
Participant will receive MI for 30 minutes in each of the first three sessions and 1 hour in each of the remaining sessions.
The control group will also receive the same duration and content of boosters as in the intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
biochemically-validated abstinence rate
Time Frame: 6-month follow-up
|
participants will be invited to join a breath test at 6-month time point after they joined the study, to determine if they have quitted smoking or not
|
6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported questionnaire
Time Frame: 1-week, 1-, 3-, 6-, 9-, and 12-month follow-ups
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Including self-reported quit rate, intention to quit, smoking reduction, depressive symptoms
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1-week, 1-, 3-, 6-, 9-, and 12-month follow-ups
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Collaborators and Investigators
Investigators
- Principal Investigator: Ka Wai Katherine Lam, Phd, The Polytechnic University of Hong Kong
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Small talk_smoking cessation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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