Clinical trial NCT06148909: Small Talk Intervention With MI for Smoking Cessation
Official title: A Pilot Study on Small Talk Intervention With MI in Assisting Smokers to Quit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Motivation
Keywords: Smoking Cessation
Motivational Interviewing
Small Talks
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: biochemically-validated abstinence rate
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Self-reported questionnaire
timeFrame: 1-week, 1-, 3-, 6-, 9-, and 12-month follow-ups
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Katherine Lam
state: Hong Kong,China
Study officials:
affiliation: the polytechnic university of hong kong
name: Ka Wai Katherine Lam, Phd
role: PRINCIPAL_INVESTIGATOR
References: