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临床试验/NCT06148909
NCT06148909尚未招募不适用

A Pilot Study on Small Talk Intervention With MI in Assisting Smokers to Quit

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
biochemically-validated abstinence rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •self-report having identified cognitive problems or psychosis, including schizophrenia, psychotic depression, and schizoaffective disorder will be excluded

研究组 & 干预措施

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.

干预措施: Small Talk Motivational Interviewing (Other)

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.

结局指标

主要结局

biochemically-validated abstinence rate

时间窗: 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

次要结局

  • Self-reported questionnaire(1-week, 1-, 3-, 6-, 9-, and 12-month follow-ups)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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