Clinical trial NCT05370352: Mobile Chat Messaging for Smoking Relapse Prevention
Official title: Effectiveness of Mobile Chat Messaging for Preventing Relapse in Smokers Who Have Recently Quit Smoking: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: relapse prevention
recurrence
mHealth
instant messaging
WhatsApp
chatbot
conversational agent
Chinese
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
name: Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
name: United Christian Nethersole Community Health Service Smoking Cessation Programme
First posted: 2022-05-11
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemically validated tobacco abstinence
timeFrame: 6 months after randomisation
Secondary outcomes:
measure: Self-reported 6-month prolonged tobacco abstinence
timeFrame: 6 months after randomisation
measure: Self-reported 7-day point prevalent tobacco abstinence
timeFrame: 3 months after randomisation
measure: Self-reported 7-day point prevalent tobacco abstinence
timeFrame: 6 months after randomisation
measure: Self-reported relapse rate
timeFrame: 3 months after randomisation
measure: Self-reported relapse rate
timeFrame: 6 months after randomisation
measure: Biochemically validated tobacco abstinence
timeFrame: 12 months after randomisation
measure: Self-reported 12-month prolonged tobacco abstinence
timeFrame: 12 months after randomisation
measure: Self-reported 7-day point prevalent tobacco abstinence
timeFrame: 12 months after randomisation
measure: Self-reported relapse rate
timeFrame: 12 months after randomisation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
city: Hong Kong
country: Hong Kong
facility: United Christian Nethersole Community Health Service Smoking Cessation Programme
Study officials:
affiliation: The University of Hong Kong
name: Tzu Tsun Luk, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.