Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial
NCT ID: NCT06261385
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2024-01-23
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Designing a Smoking Intervention for Youth Smokers Using Q-Methodology: A Pilot Randomized Controlled Trial
NCT07178899
Relapse-Prevention Booklets as an Adjunct to a Tobacco Telephone Helpline("Quitline")
NCT01352000
Mobile Chat Messaging for Smoking Relapse Prevention
NCT05370352
The Long-Term Quitting (Smoking Cessation) Study
NCT02564315
Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence
NCT00178685
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* SC counsellors from local SC clinics under Tung Wah Group of Hospitals Integrated Center on Smoking Cessation and United Christian Nethersole Community Health Service
Exclusion Criteria
* Have become pregnant in the past two months
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Health and Medical Research Fund
OTHER_GOV
The University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Derek Yee-Tak Cheung
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LKS Faculty of Medicine
Hong Kong, Hong Kong, Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
McGhee SM, Ho LM, Lapsley HM, Chau J, Cheung WL, Ho SY, Pow M, Lam TH, Hedley AJ. Cost of tobacco-related diseases, including passive smoking, in Hong Kong. Tob Control. 2006 Apr;15(2):125-30. doi: 10.1136/tc.2005.013292.
Census & Statistics Department (Hong Kong SAR government). Thematic Household Survey, Report No. 70: Pattern of Smoking. Hong Kong: Census & Statistics Department 2020.
World Health Organization. A guide for tobacco users to quit. Geneva: World Health Organization; 2014.
Lam TH. Absolute risk of tobacco deaths: one in two smokers will be killed by smoking: comment on "Smoking and all-cause mortality in older people". Arch Intern Med. 2012 Jun 11;172(11):845-6. doi: 10.1001/archinternmed.2012.1927. No abstract available.
Food and Health Bureau, Department of Health. Towards 2025: Strategy and action plan to prevent and control non-communicable diseases in Hong Kong. Hong Kong: Department of Health; 2018.
Hartmann-Boyce J, Livingstone-Banks J, Ordonez-Mena JM, Fanshawe TR, Lindson N, Freeman SC, Sutton AJ, Theodoulou A, Aveyard P. Behavioural interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD013229. doi: 10.1002/14651858.CD013229.pub2.
Jackson SE, McGowan JA, Ubhi HK, Proudfoot H, Shahab L, Brown J, West R. Modelling continuous abstinence rates over time from clinical trials of pharmacological interventions for smoking cessation. Addiction. 2019 May;114(5):787-797. doi: 10.1111/add.14549. Epub 2019 Jan 29.
Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4(4):CD006611. doi: 10.1002/14651858.CD006611.pub4.
Livingstone-Banks J, Norris E, Hartmann-Boyce J, West R, Jarvis M, Hajek P. Relapse prevention interventions for smoking cessation. Cochrane Database Syst Rev. 2019 Feb 13;2(2):CD003999. doi: 10.1002/14651858.CD003999.pub5.
Census & Statistics Department (Hong Kong SAR government). Thematic Household Survey, Report No. 64: Pattern of Smoking. Hong Kong: Census & Statistics Department 2018.
Smith AL, Chapman S, Dunlop SM. What do we know about unassisted smoking cessation in Australia? A systematic review, 2005-2012. Tob Control. 2015 Jan;24(1):18-27. doi: 10.1136/tobaccocontrol-2013-051019. Epub 2013 Sep 11.
Cheung YT, Chan CH, Lai CK, Chan WF, Wang MP, Li HC, Chan SS, Lam TH. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial. J Med Internet Res. 2015 Oct 22;17(10):e238. doi: 10.2196/jmir.4829.
Luk TT, Cheung YTD, Chan HC, Fok PW, Ho KS, Sze CD, Lam TH, Wang MP. Mobile Chat Messaging for Preventing Smoking Relapse Amid the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2023 Jan 5;25(2):291-297. doi: 10.1093/ntr/ntac045.
Tajfel H, Turner JC. The Social Identity Theory of Intergroup Behavior. In: Sidanius JTJJ, editor. Political psychology: Key readings. Key readings in social psychology. New York, NY, US: Psychology Press; 2004. p. 276-93.
Oyserman D, Smith GC, Elmore K. Identity-based motivation: Implications for health and health disparities. J Soc Iss. 2014;70(2):206-25.
Berger J, Rand L. Shifting Signals to Help Health: Using Identity Signaling to Reduce Risky Health Behaviors. Journal of Consumer Research. 2008;35(3):509-18.
Montes KS, Pearson MR. I am what I am: A meta-analysis of the association between substance user identities and substance use-related outcomes. Psychol Addict Behav. 2021 May;35(3):231-246. doi: 10.1037/adb0000721. Epub 2021 Apr 8.
Tombor I, Shahab L, Herbec A, Neale J, Michie S, West R. Smoker identity and its potential role in young adults' smoking behavior: A meta-ethnography. Health Psychol. 2015 Oct;34(10):992-1003. doi: 10.1037/hea0000191. Epub 2015 Jan 26.
Meijer E, Gebhardt WA, Dijkstra A, Willemsen MC, Van Laar C. Quitting smoking: The importance of non-smoker identity in predicting smoking behaviour and responses to a smoking ban. Psychol Health. 2015;30(12):1387-409. doi: 10.1080/08870446.2015.1049603. Epub 2015 Jun 3.
Susan ER, Isadore N. Q Methodology and Its Position in the Mixed-Methods Continuum. Operant Subjectivity. 2011;34(3):172-91.
Kufeld C. A Q-Methodology study investigating the identity self-descriptions of a group of ex-smokers. England: University of Luton; 2004.
Oyserman D. Identity-based motivation: Implications for action-readiness, procedural-readiness, and consumer behavior. J Consum Psychol. 2009;19(3):250-60.
Watts S, Stenner P. Doing the fieldwork: participants, materials and procedure. 2012 2022/03/11. In: Doing Q Methodological Research: Theory, Method and Interpretation [Internet]. London: SAGE Publications Ltd; [69-90]. Available from: https://methods.sagepub.com/book/doing-q-methodological-research.
Zabala A, Pascual U. Bootstrapping Q Methodology to Improve the Understanding of Human Perspectives. PLoS One. 2016 Feb 4;11(2):e0148087. doi: 10.1371/journal.pone.0148087. eCollection 2016.
GBD 2016 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1345-1422. doi: 10.1016/S0140-6736(17)32366-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
typology
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.