Smoking Cessation Coaching in High-Risk Situations: A Virtual Reality Study
- Conditions
- Smoking Cessation
- Registration Number
- NCT05654545
- Lead Sponsor
- Leiden University Medical Center
- Brief Summary
Smoking tobacco is an important preventable risk factor for chronic illnesses and premature death and is most prevalent among groups with a lower socio-economic position (SEP). High relapse rates show that smoking cessation interventions are often not sufficiently effective on the long-term. Potential reasons for this limited effectiveness are that these interventions are not tailored to lower-SEP smokers and do not provide sufficient support in situations when the (re)lapse risk is high; that is, high-risk situations (HRSs). A mobile phone application using an automated conversational agent could be a useful approach to promote long-term smoking cessation, as it can be tailored to lower-SEP smokers and provide support at any time of the day (also in HRSs). However, evidence on the effectiveness of this kind of applications is scarce and it is still unclear how automated conversational agents can effectively promote lapse prevention. Therefore, it is important to explore what type of lapse prevention strategies these conversational agents should use in HRSs and how these different types of support are experienced by smokers.
This virtual reality (VR) experiment will examine the preliminary effectiveness and usability of a conversational agent that supports smokers in personal HRSs. More specifically, the investigators primarily aim to examine whether the three different lapse prevention dialogs increase abstinence self-efficacy in adult smokers from different SEP groups during simulated HRSs, compared to a neutral dialog (i.e., control condition). In addition, the investigators examine the effect of the lapse prevention dialogs, compared to the neutral dialog, in simulated HRSs on subjective craving and affect. Finally, the investigators examine how adult smokers from different SEP groups experience the personalized support of a simulated conversational agent in simulated HRSs.
VR will be used to expose smokers to their personal HRSs and let them interact with a conversational agent via a simulated mobile phone. Using computer-based VR technology, three-dimensional environments can be created based on environments that smokers encounter in their daily lives (e.g., their living room or the train station from where they travel to work). This way, controlled but at the same time natural-looking environments can be used to expose smokers to their personal HRSs and measure their responses in this situation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 18 years or older
- Being able to read and understand Dutch
- Smoking ≥ 10 cigarettes a day
- Intention to quit smoking sometime in the future
- Being able to wear a VR helmet for approximately 30 minutes, with breaks in between
- Willingness to take and send videos and audio of three locations where the participant is most likely to smoke (i.e., highest chance of smoking when in the environment)
- Visual problems (e.g., limited visibility without glasses) that affect viewing VR environments (based on self-report)
- Currently involved in smoking cessation activity or therapy (based on self-report)
- When patients are deemed unfit to participate (due to, for example, psychological problems or medication). This decision is left to the discretion of the responsible researcher.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Abstinence self-efficacy Four times during the experiment which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4). Smoking abstinence self-efficacy will be assessed with a single question derived from the 'Smoking Abstinence Self-efficacy Questionnaire' (Spek et al., 2013). The six-item questionnaire measures self-efficacy regarding smoking abstinence in six different situations. However, in this experiment the situation is shown using VR (e.g., a personalized VR environment of a participant's favorite bar). Therefore, participants will only answer the question "Are you confident that you will not smoke in this situation?" while being exposed to the VR environment. Total scores range from 0 to 4, with a higher score indicating higher abstinence self-efficacy.
- Secondary Outcome Measures
Name Time Method User-experience / usability At the end of the experiment (post-intervention); experiment has a duration of 1.5 hours The usability of the conversational agent will be measured with a number of items of the System Usability Scale (Brooke, 1996). The total questionnaire consists of ten items and items are rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). Four questions of the original questionnaire are used in this study. In addition, to get a better in-depth understanding of the participants' user experience with the virtual coach, the following open-ended question will be asked: "Would it be useful to have a virtual coach available on your phone to assist with smoking cessation? Please explain.".
Phasic (state) tobacco craving Four times during the experiment which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4). To identify the level of subjective smoking craving experienced (in the VR environments), a single-item will be used (Shadel \& Cervone, 2006; Vinci et al., 2020). Participants are asked to indicate how strong their craving for a cigarette is right now. Answers are given on a scale ranging from 1 (no craving at all) to 10 (extremely strong craving), with a higher score indicating stronger subjective tobacco craving.
Positive and negative affect At the start of the experiment (baseline) and four times during the experiment, which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4) The level of positive and negative affect is assessed by having participants indicate to what extent they experienced the four basic emotions on a scale from 1 (not at all) to 10 (very much; Versluis et al., 2018). The scores on anger, anxiety and sadness will be averaged to represent negative affect. The average score on negative affect ranges from 3 to 30, with a higher score indicating stronger feelings of negative affect. The happiness-rating will represent positive affect. The average score on positive affect ranges from 1 to 10, with a higher score indicating stronger feelings of positive affect.
Acceptance of the conversational agent At the end of the experiment (post-intervention); experiment has a duration of 1.5 hours Acceptance of the conversational agent will be assessed using a set of six items. Two example items are: "How satisfied were you with the virtual coach?" and "How easy was it talking to the virtual coach?". Answers are given on a 7-point scale. The questionnaire was originally used in an intervention study (Provoost et al., 2020). Three of the items of the questionnaire had to be adjusted to make them applicable to the experimental set-up of this study. For example, the item "How much would you like to continue working with the virtual coach if the course continued?" was changed into "How much would you like to continue working with the virtual coach if it was available on your smartphone?". Total scores range from 6 to 42, with a higher score indicating higher acceptance of the conversational agent.
Trial Locations
- Locations (1)
Leiden University Medical Center (LUMC)
🇳🇱Leiden, Zuid-Holland, Netherlands