Mobile Chat Messaging for Smoking Relapse Prevention

Smoking Cessation Clinical Trial

Official title:

Effectiveness of Mobile Chat Messaging for Preventing Relapse in Smokers Who Have Recently Quit Smoking: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370352
• Other study ID #: 19201341
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: The University of Hong Kong
• Contact: Tzu Tsun Luk, PhD, RN
• Phone: 39177574
• Email: lukkevin[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most smokers return to smoking (relapse) after making a quit attempt, but evidence of effective intervention to prevent relapse is scarce. Taking advantage of recent advances in mobile technologies, this study aims to evaluate the effectiveness of a mobile chat messaging-based relapse prevention intervention in promoting successful quitting in people who recently quit smoking (recent abstainers) using a randomised controlled trial design.

Description:

Most smokers who made quit attempts and achieved short-term abstinence return to smoking (relapse) over time, even when aided by effective smoking cessation treatment. Since relapse mostly occurred in the first 4 weeks of abstinence, relapse prevention in the early phase of abstinence could potentially boost long-term abstinence. Several behavioural interventions for smoking relapse prevention have been proposed and tested in RCTs. Yet, a 2019 Cochrane review did not find traditional approaches, including self-help materials, telephone counselling and group therapy, effective in increasing long-term abstinence at 6 months or longer.

The widespread use of mobile devices has provided a highly accessible and scalable means for novel behavioural interventions for smoking cessation. A formative qualitative study in current smokers conducted by the investigators showed that mobile chat messaging is a feasible and acceptable platform for delivering smoking cessation support. A subsequent cluster randomised controlled trial on 1148 smokers found that mobile chat messaging combined with brief intervention was effective in increasing biochemically validated abstinence at 6 months. Nonetheless, whether mobile chat messaging could prevent relapse in recent abstainers has remained untested.

The investigators did a pilot trial to confirm the feasibility and acceptability of mobile chat messaging for relapse prevention in recent abstainers. This study aims to evaluate the effectiveness of mobile chat messaging relapse prevention intervention in promoting abstinence in recent abstainers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 586
• Est. completion date: January 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hong Kong residents aged 18 years or above

• Own a smartphone with WhatsApp installed

• Enrolled in a smoking cessation program under Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation

• Smoked daily before the present quit attempt

• Abstained from smoking for 3 to 30 days

Exclusion Criteria:

• Diagnosed with a mental disease or on regular psychotropic drugs

• Participating in other ongoing smoking cessation studies

Related Conditions & MeSH terms

• Recurrence
• Smoking Cessation

Intervention

Behavioral:
• Standard smoking cessation treatment
Standard smoking cessation treatment (behavioural and pharmacotherapy) provided by Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
• Personalised chat messaging
Personalised chat messaging focusing on smoking relapse prevention for 3 months from randomisation. A trained counsellor will interact with a participant individually and provide relapse prevention advice via WhatsApp. The participant can also access a supportive chatbot in WhatsApp, which will provide on-demand smoking relapse prevention support when the counsellor is not available (e.g., during nighttime).
• SMS text messaging
SMS text messaging on generic information about the harms of smoking and the benefits of quitting for 3 months from randomisation.

Locations

Country	Name	City	State
Hong Kong	Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation	Hong Kong
Hong Kong	United Christian Nethersole Community Health Service Smoking Cessation Programme	Hong Kong

Sponsors (4)

Lead Sponsor	Collaborator
The University of Hong Kong	Health and Medical Research Fund, Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation, United Christian Nethersole Community Health Service Smoking Cessation Programme

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

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. — View Citation

Luk TT, Li WHC, Cheung DYT, Wong SW, Kwong ACS, Lai VWY, Chan SS, Lam TH, Wang MP. Chat-based instant messaging support combined with brief smoking cessation interventions for Chinese community smokers in Hong Kong: Rationale and study protocol for a pragmatic, cluster-randomized controlled trial. Contemp Clin Trials. 2019 Feb;77:70-75. doi: 10.1016/j.cct.2018.12.013. Epub 2018 Dec 26. — View Citation

Luk TT, Wong SW, Lee JJ, Chan SS, Lam TH, Wang MP. Exploring Community Smokers' Perspectives for Developing a Chat-Based Smoking Cessation Intervention Delivered Through Mobile Instant Messaging: Qualitative Study. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11954. doi: 10.2196/11954. — View Citation

Wang MP, Luk TT, Wu Y, Li WH, Cheung DY, Kwong AC, Lai V, Chan SS, Lam TH. Chat-based instant messaging support integrated with brief interventions for smoking cessation: a community-based, pragmatic, cluster-randomised controlled trial. Lancet Digit Health. 2019 Aug;1(4):e183-e192. doi: 10.1016/S2589-7500(19)30082-2. Epub 2019 Jul 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically validated tobacco abstinence	Verified by an exhaled carbon monoxide level of lower than 5 parts per million or a negative salivary cotinine test	6 months after randomisation
Secondary	Self-reported 6-month prolonged tobacco abstinence	Not more than five lapses permitted for 6 months after baseline	6 months after randomisation
Secondary	Self-reported 7-day point prevalent tobacco abstinence	Being completely smoke-free in the past 7 days	3 months after randomisation
Secondary	Self-reported 7-day point prevalent tobacco abstinence	Being completely smoke-free in the past 7 days	6 months after randomisation
Secondary	Self-reported relapse rate	Defined as use of tobacco products for 7 consecutive days or longer	3 months after randomisation
Secondary	Self-reported relapse rate	Defined as use of tobacco products for 7 consecutive days or longer	6 months after randomisation
Secondary	Biochemically validated tobacco abstinence	Verified by an exhaled carbon monoxide level of lower than 5 parts per million or a negative salivary cotinine test	12 months after randomisation
Secondary	Self-reported 12-month prolonged tobacco abstinence	Not more than five lapses permitted for 12 months after baseline	12 months after randomisation
Secondary	Self-reported 7-day point prevalent tobacco abstinence	Being completely smoke-free in the past 7 days	12 months after randomisation
Secondary	Self-reported relapse rate	Defined as use of tobacco products for 7 consecutive days or longer	12 months after randomisation