Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial

January 1, 2026 updated by: Dr. Derek Yee-Tak Cheung, The University of Hong Kong
This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counselors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot study includes three phases. The first phase will be a Q-sorting process on the Q-statements which have been developed in the pilot study. Phase 2 will be the development of a typology assessment tool, intervention protocol, and training. Phase 3 will be a pilot randomized controlled trial to examine the feasibility, acceptability and preliminary efficacy of the typology-based intervention. Ethics approval will be obtained from the Institutional Review Board of the University of Hong Kong/Hong Kong Authority Hong Kong West Cluster.

This study protocol complies with the Declaration of Helsinki and the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH-GCP).

Phase 1 Q-method study (5 months) In phase 1, ex-smokers will be recruited online and in local community-based SC clinics. Mass mails including study details will be sent to all HKU staff and students. Recruitment ads will also be posted on online platforms such as Google, Facebook, and Instagram. Participants will be directed to an online Qualtrics to complete a brief screening questionnaire and provide their contact information for the sign-up process. SC clinics or services under Tung Wah Group of Hospitals, Pok Oi Hospital, Hospital Authority (HA), and Youth Quitline of the University of Hong Kong, which offer behaviour and/or pharmacological interventions. The investigators have successful experience collaborating with these service providers in recruiting smokers for several projects. For example, the investigators recruited 1,008 ex-smokers from these service providers in an HMRF-funded project in 2018-2019 (Project No. 15163001). In these clinics, potential participants shall be identified by the SC counsellors and referred to our research assistants to proceed with enrolment. In phase 3, the investigators will only recruit ex-smokers from SC clinics, because biochemical verification of both abstinence and habitual tobacco use before quitting in ex-smokers recruited from the community does not exist.

The Q-statements have been developed in our aforementioned pilot study. The Q-sorting process will be conducted on an online platform "easyHTMLQ" (Appendix 2), which is designed for completion of the Q-sorting. In this self-explanatory website, participants can easily drag the statements into the Q-sort grid according to their agreement level, and provide detailed reasons for their choices. Also, the research assistant will communicate with participants online and monitor the Q-sorting process. After the Q-sort process, the results will be documented and exported for further data analysis.

Phase 2 Intervention development (6 months) In phase 2, the investigators shall invite SC counsellors from the above SC clinics to participate in either face-to-face or online project meetings to provide feedback on the intervention protocols.

This phase aims to develop a typology assessment tool and design a typology-based intervention protocol, using the findings in Phase 1, the 3 aforementioned principles of typology-based intervention, and current smoking cessation guidelines. The screening protocol will include distinguishing statements found in Phase 1 that can characterise ex-smokers. The intervention protocol will include specific counselling principles and content for each ex-smoker class and a series of typology-based e-messages to be delivered to the corresponding class of ex-smokers via WhatsApp after counselling. The counselling shall take 5 to 10 minutes and can be fitted in current intervention protocols (5A/5R/Motivational Interview), that can address quit motivation, smoking cues and nicotine dependence.

After intervention development, the project team will invite SC counsellors for a project meeting to provide feedback on the intervention protocols. Afterwards, the project team shall revise the protocols and deliver a briefing for the SC counsellors who will deliver the intervention in Phase 3.

Phase 3 Pilot randomized control trial (7 months) The pilot 2-arm, parallel, open-labelled RCT (allocation ratio 1:1) aims to examine the feasibility, acceptability and preliminary efficacy of the typology-based intervention. SC counsellors who attend the briefing in Phase 2 will screen and recruit their SC clients to receive the typology-based intervention for smoking cessation. The SC counsellors from local clinical settings that can recruit a relatively large number of participants within the 12-week recruitment will be included, to ensure timely recruitment of sufficient participants.

During the last remote consultation with a client (mostly at 4 weeks), the SC counsellors will assess their eligibility. If they are eligible, the SC counsellors will seek their written consent and randomize them to either the intervention group or the control group. In the intervention group, in addition to routine counselling (15-30 minutes), they will classify their identity with our screening tool (developed in Phase 2) and then apply the counselling protocol for the participants (5-10 minutes). After the counselling session, the personalized e-messages will be sent to the participants by our research staff for 4 weeks.

In the control group, routine smoking cessation counselling, including generic advice on preventing smoking relapse, will be retained, and no e-messages will be sent. The investigators only deploy usual practice but not equal contact/attention treatment for the control group because the investigators aim for a superiority trial to assess the preliminary efficacy of the new intervention.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, 00
        • LKS Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria (for Ex-smoker) :

  • Being a daily smoker before enrolling into the smoking cessation service
  • Not using cigarettes for past 7 days
  • Received at least 4 weeks of smoking cessation service before enrolling into the study
  • Aged 18 years or above
  • No barriers in speaking and listening Cantonese and Mandarin and reading Chinese

Exclusion Criteria (for Ex-smoker) :

  • Have unstable physical or psychological conditions as advised by doctors or counsellors
  • Have become pregnant in the past two months

Inclusion Criteria (for SC counsellors) :

  • SC counsellors from local SC clinics under Tung Wah Group of Hospitals Integrated Center on Smoking Cessation and United Christian Nethersole Community Health Service

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
In the intervention group, in addition to routine counselling (15-30 minutes), they will classify their identity with our screening tool (developed in Phase 2) and then apply the counselling protocol for the participants (5-10 minutes). After the counselling session, the personalized e-messages will be sent to the participants by the counsellor for 4 weeks.
Behavioral: typology-based intervention

The typology-based intervention includes:

  1. typology-based counselling,
  2. personalized E-message based on the counselling content discussed
  3. a booklet introducing the typology of quit identity.

All interventions and materials are delivered by smoking counselling.
Active Comparator: Control Group
In the control group, the routine smoking cessation counselling, including generic advice on preventing smoking relapse, will be retained, and they will receive brief e-messages that only consist of general quit advice for 4 weeks.
Behavioral: Routine Treatment

The routine smoking cessation intervention includes:

  1. Routine counselling generic advice on preventing smoking relapse
  2. Brief e-messages that consist of general quit advice for 4 weeks.

Counsellors implement both routine practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-reported abstinence in the past 30 days at 2-month follow-up
Time Frame: 2 months
2 months
iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence
Time Frame: 2 months
Participants who report tobacco abstinence will be invited for a biochemical validation to test if his/her saliva cotinine is less than 30ng/ml measured by the iScreen OFD Cotinine Saliva Test Kit.
2 months
the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group.
Time Frame: 2 months

We will have 4 feasibility questions and 4 appropriateness questions for counsellor to answer from 1 (Completely disagree) to 5 (Completely agree).

Also, we will have 4 acceptability questions for ex-smokers to answer. We would like to observe if there is a difference between the intervention group and the control group
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required for the counselling
Time Frame: End of all follow-up (approximately 6 month)
The average time required for the typological counselling in minutes
End of all follow-up (approximately 6 month)
Compliance rate of the SC counsellors in following the intervention protocol
Time Frame: End of all follow-up (approximately 6 month)
There were 26 questions in the counselling protocol. SC counsellors have to record the number of questions asked during the typological counselling. The rate is calculated by "number of questions asked"/26.
End of all follow-up (approximately 6 month)
Proportion of screened clients who participate in the RCT
Time Frame: End of all follow-up (approximately 6 month)
The proportion is calculated by "Number of enrolled participants" / "Total number of participant screened"
End of all follow-up (approximately 6 month)
Dropout rate of the participants who consent to the RCT
Time Frame: End of all follow-up (approximately 6 month)
The dropout rate is calculated by "Number of participants dropout from study" / "Total number of enrolled participant"
End of all follow-up (approximately 6 month)
Satisfaction on the SC counsellors
Time Frame: 2 months
Satisfaction on the SC counsellors is measured by a 5 point Likert scale reported by the enrolled participants.
2 months
Satisfaction on the e-messages
Time Frame: 2 months
Satisfaction on the e-messages is measured by a 10 point Likert scale reported by the enrolled participants.
2 months
Frequency of reading the e-messages
Time Frame: 2 months
The Frequency of reading the e-messages is measured by 5 point Likert scale, which includes the option (5) I read all of them, (4) I read most of them, (3) I read half of them, (2) I read some of them, and (1) I read none of them.
2 months
Perceived effectiveness on the intervention
Time Frame: 2 months
The perceived effectiveness on the intervention is measured by a 10 point likert scale. Participant will rate the usefulness of the messages in helping them to maintain smoking abstinence (10: Very useful | 0: Useless).
2 months
Satisfaction on the enrolment procedures
Time Frame: 2 months
Satisfaction on the enrolment procedures is measured by a 10 point Likert scale reported by the participants (0: The enrollment procedure is slow and complicated | 10: the enrollment procedure is fast and simple).
2 months
Intention to recommend the intervention to other smokers
Time Frame: 2 months
Intention to recommend the intervention to other smokers is measured by a 10 point Likert scale, 10: strongly recommended to other smokers | 0: not recommended to other smoker
2 months
Satisfaction about the intervention from SC counsellor
Time Frame: End of all follow-up (approximately 6 month)
Satisfaction about the intervention from SC counsellor is measured by a 5 point Likert scale. SC counsellor will rate the effectiveness of the typological counselling in helping their client to quit smoking, from 1: very ineffective to 5: very effective.
End of all follow-up (approximately 6 month)
Perceived appropriateness of the intervention length from SC counsellor
Time Frame: End of all follow-up (approximately 6 month)
The perceived appropriateness of the intervention length from SC counsellor is measured by a 5 point Likert scale. SC counsellor will be asked if they agreed that the length of the typological counselling is suitable for their client, from 1 strongly disagree to 5 strongly agree.
End of all follow-up (approximately 6 month)
Satisfaction on the enrolment and counselling procedures from SC counsellors
Time Frame: End of all follow-up (approximately 6 month)
The satisfaction on the enrolment procedures from SC counsellors is measured by a 5 point Likert scale. Counsellors will be asked if they agreed that enrolment and counselling procedures is simple and could be easily done in the SC clinics, from 1: strongly disagree to 5: strongly agree.
End of all follow-up (approximately 6 month)
Perceived effectiveness of the screening tool from SC counsellor
Time Frame: End of all follow-up (approximately 6 month)
The perceived effectiveness of the screening tool from SC counsellor is measured by a 5 point Likert scale. SC counsellor will be asked if they agreed that the typological intervention can help them screen out smokers who are prone to relapse, from 1: strongly disagree to 5: strongly agree.
End of all follow-up (approximately 6 month)
Perceived clients' acceptance of the intervention from SC counsellor
Time Frame: 2 months
The Perceived clients' acceptance of the intervention from SC counsellor is measured by a 5 point Likert scale. Participants are asked if they agreed that counselling content provided the SC counselling gain their trust and acceptance, from 1: strongly disagree to 5: strongly agree.
2 months
Intention to apply this intervention in other clients from SC counsellors
Time Frame: End of all follow-up (approximately 6 month)
Intention to apply this intervention in other clients from SC counsellors is measured by a 5 point Likert scale. SC counsellors are asked if they want to apply the typological intervention to other clients in future, 1: I will not apply it to my client in the future, 5: I want to apply it my client in the future.
End of all follow-up (approximately 6 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Health and Medical Research Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

January 1, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • typology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Research data and documentation will be available upon request

IPD Sharing Time Frame

3 years after the completion of the relevant publications

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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