NCT06148909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 20, 2023

Last Update Submit

November 20, 2023

Conditions

Keywords

Smoking CessationMotivational InterviewingSmall Talks

Outcome Measures

Primary Outcomes (1)

  • 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

    6-month follow-up

Secondary Outcomes (1)

  • Self-reported questionnaire

    1-week, 1-, 3-, 6-, 9-, and 12-month follow-ups

Study Arms (2)

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.

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.

Interventions

Combining small talks and skills on Motivational Interviewing in the smoking cessation services

Small Talk Motivational Interviewing (STMI)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katherine Lam

Hong Kong, Hong Kong,China, 0000, Hong Kong

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Ka Wai Katherine Lam, Phd

    the polytechnic university of hong kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Wai Katherine Lam, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations