The PAS study: A randomized controlled trial evaluating the effectiveness of a web-based multiple tailored smoking cessation programme and tailored counselling by practice nurses

BACKGROUND There is an ongoing debate whether or not electronic cigarettes (e-cigarettes) should be advocated for smoking cessation. Because of this uncertainty, information about the use of e-cigarettes for smoking cessation is usually not provided in governmental smoking cessation communications. However, there is an information need among smokers, because – despite this uncertainty – e-cigarettes are used by many smokers to reduce and/or quit tobacco smoking. OBJECTIVE To describe the study protocol of a Randomized Controlled Trial (RCT) to assess the effect of providing tailored information about e-cigarettes compared to not providing this information on determinants of decision-making and smoking reduction and abstinence. This information is provided in the context of a digital smoking cessation intervention. METHODS An RCT with a 6-month follow-up period will be conducted among adult smokers motivated to quit smoking within 5 years. Participants will be 1:1 randomized into either the intervention condition or control condition. Grounded on the I-Change Model, participants in both conditions will receive tailored feedback on attitude, social influence, preparatory plans, self-efficacy, and coping plans. Information on six clusters of smoking cessation methods will be provided in both conditions. Smokers in the intervention condition will also receive detailed tailored information on e-cigarettes; smokers in the control condition will not receive this information. The primary outcome measure will be the number of tobacco cigarettes smoked in the past 7 days. Secondary outcome measures will include 7-day point prevalence tobacco abstinence, 7-day point prevalence e-cigarette abstinence, and determinants of decision-making (i.e., knowledge and attitude regarding e-cigarettes). All outcomes will be self-assessed through web-based questionnaires. RESULTS Recruitment began in March 2020 and was completed by July 2020. We expect to publish the results in March 2021. CONCLUSIONS The experimental design of the study allows conclusions to be formed regarding the effects of tailored information about e-cigarettes on decision-making and smoking behavior. The findings can inform the development of future smoking cessation interventions. CLINICALTRIAL Dutch Trial Register, Trial NL8330 (https://www.trialregister.nl/trial/8330)

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A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial

JMIR Formative Research ◽

10.2196/formative.7570 ◽

2020 ◽

Vol 4 (6) ◽

pp. e7570 ◽

Cited By ~ 1

Author(s):

Christopher W Kahler ◽

Amy M Cohn ◽

Catherine Costantino ◽

Benjamin A Toll ◽

Nichea S Spillane ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Text Messaging ◽

Controlled Trial ◽

Text Messages ◽

Smoking Cessation Program ◽

Web Based ◽

Randomized Controlled ◽

To Receive ◽

Pilot Randomized Controlled Trial

Background Heavy drinking (HD) is far more common among smokers compared with nonsmokers and interferes with successful smoking cessation. Alcohol-focused smoking cessation interventions delivered by counselors have shown promise, but digital versions of these interventions—which could have far greater population reach—have not yet been tested. Objective This pilot randomized controlled trial aimed to examine the feasibility, acceptability, and effect sizes of an automated digital smoking cessation program that specifically addresses HD using an interactive web-based intervention with an optional text messaging component. Methods Participants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day. Participants were randomized to receive EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD). Outcomes were assessed by web-based surveys at 1 and 6 months. Results Participants reported high satisfaction with the website and the optional text messaging component. Total engagement with both EX-S and EX-HD was modest, with participants visiting the website a median of 2 times, and 52.9% of the participants enrolled to receive text messages. Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed. Although smoking outcomes tended to favor EX-HD, the condition effects were small and nonsignificant. A significantly smaller proportion of participants in EX-HD reported having a lapse back to smoking when drinking alcohol (7/58, 16%) compared with those in EX-S (18/61, 41%; χ21=6.2; P=.01). Conclusions This is the first trial to examine a digital smoking cessation program tailored to HD smokers. The results provide some initial evidence that delivering such a program is feasible and may reduce the risk of alcohol-involved smoking lapses. However, increasing engagement in this and other web-based interventions is a crucial challenge to address in future work. Trial Registration ClinicalTrials.gov NCT03068611; https://clinicaltrials.gov/ct2/show/NCT03068611

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