Smoking CessationNCT06148909
Small Talk Intervention With MI for Smoking Cessation
A study testing Small Talk Motivational Interviewing in people with Smoking Cessation and Motivation, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Motivation
- What is being tested?
- Small Talk Motivational Interviewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2023to 1 Dec 2025
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- self-report having identified cognitive problems or psychosis, including schizophrenia, psychotic depression, and schizoaffective disorder will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Motivation
- Being tested
- Small Talk Motivational Interviewing
- Keywords
- Smoking Cessation, Motivational Interviewing, Small Talks
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Talk Motivational InterviewingOther
Combining small talks and skills on Motivational Interviewing in the smoking cessation services
| Study group | Role | What they receive |
|---|---|---|
| Small Talk Motivational Interviewing (STMI) | Experimental | 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. Receives: Other: Small Talk Motivational Interviewing |
| Control (only MI) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
biochemically-validated abstinence rate
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
Measured: 6-month follow-up
Secondary outcomes (1)
Self-reported questionnaire
Including self-reported quit rate, intention to quit, smoking reduction, depressive symptoms
Measured: 1-week, 1-, 3-, 6-, 9-, and 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ka Wai Katherine Lam, Phd, Principal investigator, the polytechnic university of hong kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148909
- Sponsor's protocol ID
- Small talk_smoking cessation
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Small Talk Intervention With MI in Assisting Smokers to Quit
- ClinicalTrials.gov ID
- NCT06148909
- Acronym / sponsor ID
- Small talk_smoking cessation
- Conditions
- Smoking Cessation, Motivation
- Keywords
- Smoking Cessation, Motivational Interviewing, Small Talks
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 28 Nov 2023 (actual)
- 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 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small Talk Motivational Interviewing (STMI) | Experimental | Other: Small Talk Motivational Interviewingduring 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. |
| Control (only MI) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- self-report having identified cognitive problems or psychosis, including schizophrenia, psychotic depression, and schizoaffective disorder will be excluded
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 |
|---|---|---|
| Small Talk Motivational InterviewingCombining small talks and skills on Motivational Interviewing in the smoking cessation services | Other | Small Talk Motivational Interviewing (STMI) |
Primary outcome
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
1 secondary outcome
Self-reported questionnaire
Time frame: 1-week, 1-, 3-, 6-, 9-, and 12-month follow-ups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
Ka Wai Katherine Lam, Phd principal investigator
the polytechnic university of hong kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Talk Motivational Interviewing in people with Smoking Cessation and Motivation, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 6 inclusion and 1 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 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ka Wai Katherine Lam, Phd (27666420, kw-katherine.lam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemically-validated abstinence rate (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.